Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information; Availability, 56644-56649 [E9-26291]
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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
submit a complete ANADA or to submit
information in support of an ANADA
for phased review followed by the
submission of an Administrative
ANADA when FDA finds that all the
applicable technical sections for an
ANADA are complete. FDA requests
that an applicant accompany ANADAs
and requests for phased review of data
to support ANADAs with the Form FDA
356v to ensure efficient and accurate
processing of information to support
approval of the generic new animal
drug.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
FD&C Act
Section 512(n)(1)
FDA Form
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
ANADA
356 V
17
1
17
159
2,703
Phased Review
with
Administrative
ANADA
356 V
5
5
25
31.8
795
Total
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1There
3,498
are no capital costs or operating and maintenance costs associated with this collection of information.
ANADA paperwork burden (Section
512(n)(1) of the act) (21 U.S.C.
360b(b)(2)): Over the past 5 fiscal years,
from October 2003 through September
2008, FDA has received an average of 22
ANADAs per year. FDA estimates that
preparing the paperwork required under
Section 512 (n)(1) of the act to be
contained in an ANADA, whether all of
the information is submitted with the
ANADA or the applicant submits
information for phased review followed
by an Administrative ANADA that
references that information, will take
approximately 159 hours. FDA is
estimating that each ANADA that uses
the phased review process will have
approximately 5 phased reviews per
application. Therefore, assuming that 5
respondents will take advantage of the
phased review option per year and an
average of 5 phased reviews are
submitted per application, times 31.8
hours per phased review, equals 795
total hours per year or 159 hours per
application.
FDA believes that with time, more
sponsors will take advantage of the
phased review option, as it provides
greater flexibility. Eventually, phased
review will increase to the point of
being the majority of ANADAs
submitted during the course of the year.
FDA also estimates that it takes
sponsors of ANADAs approximately 25
percent less time to put together the
information to support an ANADA than
an NADA because they only need to
provide evidence of bioequivalence and
not the data required in an NADA to
support a full demonstration of safety
and effectiveness.
Form FDA 356v: FDA requests that an
applicant fill out and send in with an
ANADA and requests for phased review
of data to support an ANADAs, a Form
FDA 356v to ensure efficient and
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accurate processing of information to
support the approval of a generic new
animal drug.
This notice also refers to previously
approved collections of information
found in FDA regulations. The
collections of information under 21 CFR
514.80, which describes records and
reports that are required post approval,
have been approved under OMB Control
No. 0910–0284.
Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26290 Filed 10–30–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0521]
Authorization of Emergency Use of the
Antiviral Product Peramivir
Accompanied by Emergency Use
Information; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for peramivir 200 milligrams (mg)/20
milliliter (mL) (10 mg/mL) single use
vial manufactured for BioCryst
Pharmaceuticals, Inc. (BioCryst) for
intravenous (IV) administration in
certain adult and pediatric patients.
Peramivir is a drug that is not approved
by FDA. FDA is issuing the
Authorization under the Federal Food,
Drug, and Cosmetic Act (the act), as
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requested by the Centers for Disease
Control and Prevention (CDC). The
Authorization contains, among other
things, conditions on the emergency use
of peramivir. The Authorization follows
the determination by then Acting
Secretary of the U.S. Department of
Health and Human Services Charles E.
Johnson (then Acting Secretary) that a
public health emergency exists
involving Swine Influenza A (now
known as ‘‘2009–H1N1 Influenza’’) that
affects, or has the significant potential to
affect, national security. The
determination has been renewed. On the
basis of such determination, the
Secretary declared an emergency
justifying the authorization of the
emergency use of the antiviral
peramivir, accompanied by emergency
use information, subject to the terms of
any authorization issued under the act.
The Authorization, which includes an
explanation of the reasons for issuance,
is reprinted in this document. The
notice of the declaration of the Secretary
is announced elsewhere in this issue of
the Federal Register.
DATES: The Authorization is effective as
of October 23, 2009.
ADDRESSES: Submit written requests for
single copies of the Emergency Use
Authorization(s) to the Office of
Counterterrorism and Emerging Threats
(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
Authorization(s) may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the Authorizations.
FOR FURTHER INFORMATION CONTACT:
RADM Boris Lushniak, Office of
Counterterrorism and Emerging Threats
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(HF–29), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4067.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the act (21 U.S.C.
360bbb-3), as amended by the Project
BioShield Act of 2004 (Public Law 108–
276), allows FDA to strengthen the
public health protections against
biological, chemical, nuclear, and
radiological agents. Among other things,
section 564 of the act allows FDA to
authorize the use of an unapproved
medical product or an unapproved use
of an approved medical product during
a public health emergency that affects,
or has a significant potential to affect,
national security, and that involves
biological, chemical, radiological, or
nuclear agent or agents, or a specified
disease or condition that may be
attributable to such agent or agents.
With this EUA authority, FDA can help
assure that medical countermeasures
may be used in an emergency to
diagnose, treat, or prevent serious or
life-threatening diseases or conditions
caused by such agents, when there are
no adequate, approved, and available
alternatives.
Section 564(b)(1) of the act provides
that, before an EUA may be issued, the
Secretary must declare an emergency
justifying the authorization based on
one of the following grounds: ‘‘(A) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a specified biological, chemical,
radiological, or nuclear agent or agents;
(B) a determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces of attack with a specified
biological, chemical, radiological, or
nuclear agent or agents; or (C) a
determination by the Secretary of a
public health emergency under section
319 of the Public Health Service Act
(PHS Act) that affects, or has a
significant potential to affect, national
security, and that involves a specified
biological, chemical, radiological, or
nuclear agent or agents, or a specified
disease or condition that may be
attributable to such agent or agents.’’
Once the Secretary has declared an
emergency justifying an authorization
under section 564 of the act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the act, FDA is required to
publish in the Federal Register, a notice
of each authorization, and each
termination or revocation of an
authorization, and an explanation of the
reasons for the action. Section 564 of the
act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use in a declared
emergency. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under sections 505, 510(k),
and 515 of the act (21 U.S.C. 355,
360(k), and 360e) or section 351 of the
Public Health Service Act (42 U.S.C.
262). FDA may issue an EUA only if,
after consultation with the National
Institutes of Health and CDC (to the
extent feasible and appropriate given
the circumstances of the emergency),
FDA1 concludes: ‘‘(1) that an agent
specified in a declaration of emergency
can cause a serious or life-threatening
disease or condition; (2) that, based on
the totality of scientific evidence
available to FDA, including data from
adequate and well-controlled clinical
trials, if available, it is reasonable to
believe that: (A) the product may be
effective in diagnosing, treating, or
preventing—(1) such disease or
condition; or (2) a serious or lifethreatening disease or condition caused
by a product authorized under Section
564, approved or cleared under this Act,
or licensed under Section 351 of the
PHS Act, for diagnosing, treating, or
preventing such a disease or condition
caused by such an agent; and (B) the
known and potential benefits of the
product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product; (3) that
there is no adequate, approved, and
available alternative to the product for
diagnosing, preventing, or treating such
disease or condition; and (4) that such
other criteria as the Secretary may by
regulation prescribe are satisfied.’’
No other criteria of issuance have
been prescribed by regulation under
section 564(c)(4) of the act. Because the
statute is self-executing, FDA does not
require regulations or guidance to
implement the EUA authority. However,
in the Federal Register of July 26, 2007
(72 FR 41083), FDA published a notice
of availability of a guidance entitled
‘‘Emergency Use Authorization of
Medical Products’’ to provide more
information for stakeholders and the
public about the EUA authority and the
agency’s process for the consideration of
EUA requests.
II. EUA Request for Peramivir
On April 26, 2009, under section
564(b)(1)(C) of the act (21 U.S.C.
360bbb-3(b)(1)(C)), the then Acting
Secretary determined that a public
health emergency exists involving
Swine Influenza A (now known as
2009–H1N1 influenza) that affects, or
has the significant potential to affect,
national security. The declaration has
been renewed. On October 20, 2009,
under section 564(b) of the act, and on
the basis of such determination, the
Secretary declared an emergency
justifying the authorization of the
emergency use of the antiviral
peramivir, accompanied by emergency
use information, subject to the terms of
any authorization issued under 21
U.S.C. 360bbb-3(a). Notice of the
declaration of the Secretary is published
elsewhere in this issue of the Federal
Register. On October 23, 2009, CDC
requested and FDA issued the EUA for
peramivir 200 mg/ 20 mL (10 mg/mL)
single use vial manufactured for
BioCryst for IV administration in certain
adult and pediatric patients,
accompanied by emergency use
instructions, subject to the terms and
conditions of the authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for
issuance of the Authorizations under
section 564(c) of the act are met, FDA
has authorized the emergency use of
peramivir 200 mg/ 20 mL (10 mg/mL)
single use vial manufactured for
BioCryst for IV administration in certain
adult and pediatric patient,
accompanied by emergency use
information, subject to the terms and
conditions of the authorization.
The Authorization for peramivir 200
mg/ 20 mL (10 mg/mL) single use vial
manufactured for BioCryst for IV
administration follows and provides an
explanation of the reasons for its
issuance, as required by section
564(h)(1) of the act:
1 The Secretary has delegated her authority to
issue an EUA under section 564 of the act to the
Commissioner of Food and Drugs.
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Federal Register / Vol. 74, No. 210 / Monday, November 2, 2009 / Notices
October 23, 2009
Thomas R. Frieden, MD, MPH
Director
Centers for Disease Control and Prevention
1600 Clifton Rd, MS D-14
Atlanta, GA 30333
Dear Dr. Frieden:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization
(EUA) for the emergency use of the unapproved drug peramivir administered intravenously for treatment of 2009 H1N1 influenza
virus (hereafter ‘‘2009 H1N1’’) in certain adult and pediatric patients, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the then Acting Secretary of the
Department of Health and Human Services (DHHS) determined that a public health emergency exists involving Swine Influenza A
(now referred to as ‘‘2009 H1N1’’) that affects or has significant potential to affect national security. The Secretary has renewed
the determination. Pursuant to section 564(b) of the Act (21 U.S.C. § 360bbb-3(b)), and on the basis of such determination, the
Secretary of DHHS declared an emergency justifying the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under section 564(a) of the Act (21 U.S.C.
§ 360bbb-3(a)).
Having consulted with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and having concluded that the criteria for issuance of this authorization under section 564(c) of the Act (21 U.S.C. § 360bbb-3(b)) are met,
I am authorizing the emergency use of peramivir1 administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and
pediatric patients meets the criteria for issuance of an authorization under section 564(c) of the Act, because I have concluded
that:
(1) 2009 H1N1 can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that peramivir may be effective when
administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients, and that the known and potential benefits of peramivir, when administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric
patients, outweigh the known and potential risks of peramivir; and
(3) there is no adequate, approved, and available alternative to the emergency use of peramivir administered intravenously for
the treatment of 2009 H1N1 in certain adult and pediatric patients.2
Therefore, I have concluded that the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in
certain adult and pediatric patients meets the above statutory criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the emergency use of
authorized peramivir for the treatment of 2009 H1N1 in certain adult and pediatric patients. The emergency use of authorized
peramivir under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and the conditions of authorization set forth below.
Peramivir (a neuraminidase inhibitor) is an unapproved drug that it is currently being studied in clinical investigations. Peramivir is
not currently approved by FDA for any use in the United States.
The authorized peramivir is as follows:
• Peramivir injection: 200mg/20mL (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst). (See
Section IV.D.3. of this letter).
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1. The above peramivir product is authorized only for intravenous (IV) administration.
2. The above peramivir product is authorized for the treatment of certain patients with suspected or laboratory confirmed 2009
H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, the peramivir product is authorized only for the following patients who are admitted to a hospital and under the
care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-related adverse events):
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or
is not feasible, or
(iii) the clinician judges IV therapy is appropriate due to other circumstances.
b. Pediatric patients for whom an IV agent is clinically appropriate because:
(i) patient not responding to either oral or inhaled antiviral therapy, or
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(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or
is not feasible).
3. The above peramivir product may only include product distributed from Strategic National Stockpile (SNS), in which case such
product is authorized only to be labeled with the attached label.
4. The above peramivir product is authorized to be accompanied by the following written information pertaining to the emergency
use, which is attached and authorized to be made available to health care providers and patients (and parents/caregivers):
• Fact Sheet for Health Care Provider
• Fact Sheet for Patients and Parents/Caregivers
CDC, hospitals, and health care providers receiving authorized peramivir are also authorized to make available additional written
information relating to the emergency use of authorized peramivir that is consistent with and does not exceed the terms of this letter of authorization (including the above referenced facts sheets).
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of
authorized peramivir, when used for the treatment of H1N1 in certain adult and pediatric patients, outweigh the known and potential risks of such product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is
reasonable to believe that the authorized peramivir may be effective for the treatment of 2009 H1N1 in certain adult and pediatric
patients pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available, including the information supporting the conclusions described in Section I of this letter above, and concludes that the authorized peramivir when used
for the treatment of 2009 H1N1 in certain adult and pediatric patients, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS’s determination under section
564(b)(1)(C) described above and the Secretary of DHHS’s corresponding declaration under section 564(b)(1), the peramivir described above is authorized for the treatment of 2009 H1N1 in certain adult and pediatric patients.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when
the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
This letter covers authorized peramivir as previously manufactured for BioCryst as of the date of this letter as well as authorized
peramivir that may be manufactured for BioCryst after such date, insofar as FDA has determined that the methods used in, and
the facilities and controls used for, the manufacturing, processing and packing of authorized peramivir are adequate to preserve
its identity, strength, quality and purity.
Authorized peramivir should be held in accordance with its labeled and appropriate product storage conditions (ambient temperature, 15°C-30°C or 59°F-86°F). However, in order to ensure the delivery and availability of authorized peramivir, I am waiving current good manufacturing practice (CGMP) requirements with respect to proper storage conditions of temperature during the shipment and holding of authorized peramivir by CDC and/or its designees for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to CDC and/or its designees. Significant excursions from labeled storage conditions should be
documented to the extent practicable given the circumstances of the emergency, and need not be supported by additional testing
by CDC or its designees.?
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
A. CDC
A.1. CDC will decide how authorized peramivir will be distributed under its direction to Hospitals upon request by licensed treating
clinicians at the Hospitals to the extent such decisions are consistent with and do not exceed the terms of this letter; except
that CDC will ensure that authorized peramivir will be distributed to Hospitals as soon as possible within 24 hours of CDC’s decision to distribute such product, to the extent practicable given the circumstances of the emergency.
A.2. CDC will maintain adequate records regarding distribution under its direction of authorized peramivir (i.e., lot numbers, quantity, receiving site, receipt date, unique identifier(s) (e.g., Peramivir Request number(s))).
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A.3. CDC will notify FDA on a weekly basis (unless otherwise specified by FDA) of the quantity of and to which Hospitals authorized peramivir is distributed under its direction. CDC will also include in the notification the unique identifier(s) (e.g., Peramivir
Request number(s)).
A.4. CDC will ensure that authorized peramivir is distributed for use under its direction only within the expiry dates identified by
FDA. CDC will inform Hospitals receiving authorized peramivir under its direction of the expiry dates by which authorized
peramivir is to be used if authorized peramivir is nearing expiry. CDC will maintain adequate records regarding the expiry dates
by which authorized peramivir is to be used.
A.5. CDC will ensure that Hospitals receiving authorized peramivir under its direction are informed of this letter, including the
terms and conditions as well as any authorized amendments thereto.
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A.6. CDC will make available through appropriate means to the Hospitals receiving authorized peramivir under its direction the
authorized Fact Sheet for Health Care Providers and Fact Sheet for Patients and Parents/Caregivers as well as any authorized
amendments thereto.
A.7. CDC will perform adverse event monitoring and compliance activities (e.g., follow-up surveys) designed: (1) to ensure that
selected adverse events and all medication errors associated with the use of authorized peramivir are reported to FDA as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at https://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) to ensure that such reports include in the description section of the
MedWatch Form 3500 the words ‘‘Peramivir EUA’’ and include unique identifier(s) (e.g., Peramivir Request number(s)), and (3)
to ensure that such reports are made within seven calendar days from the onset of the event. CDC will report such information
to FDA upon request.
A.8. CDC will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed the terms of this letter (including the facts sheets referenced in Section II of
this letter).
A.9. CDC will make available to FDA upon request any records maintained in connection with this letter.
B. Hospitals to Which Authorized Peramivir is Distributed
B.1 Such Hospitals will make available through appropriate means to relevant health care providers this letter, including the terms
and conditions as well as any authorized amendments thereto.
B.2. Such Hospitals will make available through appropriate means to relevant health care providers and patients and/or parents/
caregivers the authorized Fact Sheet for Health Care Providers and Fact Sheet for Patients and Parents/Caregivers as well as
any authorized amendments thereto.
B.3. Such Hospitals will ensure that relevant health care providers abide by the institutional procedures regarding drug accountability. Such Hospitals will maintain adequate records showing receipt, use, and disposition of authorized peramivir.
B.4. Such Hospitals will ensure that the emergency use of authorized peramivir is limited to patients who are under the care or
consultation of a licensed clinician (e.g., skilled in the diagnosis and management of patients with systemic illness, including
recognition and management of medication-related adverse events).
B.5. Such Hospitals will conduct any follow-up requested by FDA and/or CDC regarding medication errors and adverse events.
B.6. Such Hospitals will only make available additional written information relating to the emergency use of authorized peramivir
to the extent that it is consistent with and does not exceed the terms of this letter of authorization (including the facts sheets
referenced in Section II of this letter).
B.7. Such Hospitals will make available to FDA and/or CDC upon request any records maintained in connection with this letter.
Upon request, such Hospitals will report to FDA and/or CDC information with respect to the emergency use of authorized
peramivir.
C. Health Care Providers Conducting Activities With Respect to Authorized Peramivir3
C.1. Health Care Providers will be aware of this letter, including the terms and conditions as well as any authorized amendments
thereto. Health Care Providers will read the Fact Sheet for Health Care Providers, including the sections on Mandatory Requirements for Peramivir Administration Under Emergency Use Authorization and Considerations Prior to Peramivir Use Under EUA
as well as any amendments thereto. (See Fact Sheet for Health Care Providers).
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C.2. Health Care Providers prescribing and/or administering authorized peramivir will ensure that the authorized Fact Sheet for
Patients and Parents/Caregivers, as well as any authorized amendments thereto, have been made available to patients and/or
parents/caregivers through appropriate means. Such Health Care Providers (to the extent practicable given the circumstances
of the emergency) will document in the patient’s medical record that: (a) patients/caregivers have been given the Fact Sheet for
Patients and Parents/Caregivers, (b) patients/caregivers have been informed of the alternatives to receiving authorized
peramivir, and (c) patients/caregivers have been informed that peramivir is an unapproved drug that is authorized for use under
Emergency Use Authorization.
C.3. Prescribing Health Care Providers (or their designees) will ensure that: (1) selected adverse events and all medication errors
associated with the use of authorized peramivir are reported as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at https://www.fda.gov/
medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) OR by mail (MedWatch, 5600 Fishers Lane,
Rockville, MD 20852-9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) that
such reports include in the description section of the MedWatch Form 3500 the words ‘‘Peramivir EUA’’ and include unique
identifier(s); and (3) that such reports are made within seven calendar days from the onset of the event. Such Health Care Providers or their designees will conduct any follow-up requested by FDA and/or CDC.
C.4. Health Care Providers will prescribe and/or administer authorized peramivir only for the treatment of certain patients with
suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be
2009 H1N1 based on community epidemiology. Specifically, peramivir is authorized only for the following patients who are admitted to a hospital and under the care or consultation of a licensed clinical (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-related adverse events):
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a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable
or is not feasible, or
(iii) the clinician judges IV therapy is appropriate due to other circumstances.
b. Pediatric patients for whom an IV agent is clinically appropriate because:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable
or is not feasible).
C.5. Health Care Providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to peramivir dose calculation and first administration. (See Fact Sheet For Health Care Providers; Dosage and Administration for Impaired Renal Function Dosing).
C.6. Health Care Providers prescribing and/or administering authorized peramivir will ensure that patients with history of severe
allergic reaction to any other neuraminidase inhibitor (zanamivir or oseltamivir) or any ingredient of peramivir will not receive authorized peramivir. (See Fact Sheet for Health Care Providers; Product Description.)
C.7. Health Care Providers will only make available additional written information relating to the emergency use of authorized
peramivir to the extent that it is consistent with and does not exceed the terms of this letter of authorization (including the facts
sheets referenced in Section II of this letter).
C.8. Heath Care Providers will make available to FDA and/or CDC upon request any records maintained in connection with this
letter. Upon request, Health Care Providers will report to FDA and/or CDC information with respect to the emergency use of authorized peramivir.
D. BioCryst
D.1. BioCryst will post on its website the following statement: ‘‘For information about the FDA-authorized emergency use of
peramivir, please see www.cdc.gov/h1n1flu/eua.’’
D.2. BioCryst will distribute authorized peramivir only to CDC and/or its designees subject to the terms and conditions of this letter.
D.3 BioCryst will contact FDA concerning the need for any FDA review and approval before any changes are made to the manufacturing, packaging, and labeling processes authorized as of the date of this letter.
D.4. BioCryst (or anyone acting on behalf of BioCryst) will not represent authorized peramivir in a promotional context or otherwise promote authorized peramivir.
D.5. BioCryst will make available to FDA and (as reasonably appropriate) CDC upon request any records maintained in connection with this letter. Upon request, BioCryst will report to FDA and/or (as reasonably appropriate) CDC information with respect
to the emergency use of authorized peramivir.
The emergency use of authorized peramivir as described in this letter of authorization must comply with the conditions above and
all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
srobinson on DSKHWCL6B1PROD with NOTICES
1 FDA is authorizing the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and
pediatric patients as described in the scope section of this letter (Section II of this letter). For ease of reference, this letter of authorization will also use the term ‘‘authorized peramivir.’’
2 No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
3 The activities with respect to authorized peramivir refer to requesting, preparing, prescribing, and/or administering authorized
peramivir, unless otherwise specified.
Dated: October 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26291 Filed 10–30–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
VerDate Nov<24>2008
17:03 Oct 30, 2009
Jkt 220001
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
E:\FR\FM\02NON1.SGM
02NON1
]]>Agencies
[Federal Register Volume 74, Number 210 (Monday, November 2, 2009)]
[Notices]
[Pages 56644-56649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26291]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0521]
Authorization of Emergency Use of the Antiviral Product Peramivir
Accompanied by Emergency Use Information; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for peramivir 200 milligrams (mg)/20 milliliter (mL) (10 mg/mL) single
use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst) for
intravenous (IV) administration in certain adult and pediatric
patients. Peramivir is a drug that is not approved by FDA. FDA is
issuing the Authorization under the Federal Food, Drug, and Cosmetic
Act (the act), as requested by the Centers for Disease Control and
Prevention (CDC). The Authorization contains, among other things,
conditions on the emergency use of peramivir. The Authorization follows
the determination by then Acting Secretary of the U.S. Department of
Health and Human Services Charles E. Johnson (then Acting Secretary)
that a public health emergency exists involving Swine Influenza A (now
known as ``2009-H1N1 Influenza'') that affects, or has the significant
potential to affect, national security. The determination has been
renewed. On the basis of such determination, the Secretary declared an
emergency justifying the authorization of the emergency use of the
antiviral peramivir, accompanied by emergency use information, subject
to the terms of any authorization issued under the act. The
Authorization, which includes an explanation of the reasons for
issuance, is reprinted in this document. The notice of the declaration
of the Secretary is announced elsewhere in this issue of the Federal
Register.
DATES: The Authorization is effective as of October 23, 2009.
ADDRESSES: Submit written requests for single copies of the Emergency
Use Authorization(s) to the Office of Counterterrorism and Emerging
Threats (HF-29), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization(s) may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.
FOR FURTHER INFORMATION CONTACT: RADM Boris Lushniak, Office of
Counterterrorism and Emerging Threats
[[Page 56645]]
(HF-29), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-4067.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the act (21 U.S.C. 360bbb-3), as amended by the
Project BioShield Act of 2004 (Public Law 108-276), allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product during a
public health emergency that affects, or has a significant potential to
affect, national security, and that involves biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents. With this
EUA authority, FDA can help assure that medical countermeasures may be
used in an emergency to diagnose, treat, or prevent serious or life-
threatening diseases or conditions caused by such agents, when there
are no adequate, approved, and available alternatives.
Section 564(b)(1) of the act provides that, before an EUA may be
issued, the Secretary must declare an emergency justifying the
authorization based on one of the following grounds: ``(A) a
determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a specified
biological, chemical, radiological, or nuclear agent or agents; (B) a
determination by the Secretary of Defense that there is a military
emergency, or a significant potential for a military emergency,
involving a heightened risk to United States military forces of attack
with a specified biological, chemical, radiological, or nuclear agent
or agents; or (C) a determination by the Secretary of a public health
emergency under section 319 of the Public Health Service Act (PHS Act)
that affects, or has a significant potential to affect, national
security, and that involves a specified biological, chemical,
radiological, or nuclear agent or agents, or a specified disease or
condition that may be attributable to such agent or agents.''
Once the Secretary has declared an emergency justifying an
authorization under section 564 of the act, FDA may authorize the
emergency use of a drug, device, or biological product if the agency
concludes that the statutory criteria are satisfied. Under section
564(h)(1) of the act, FDA is required to publish in the Federal
Register, a notice of each authorization, and each termination or
revocation of an authorization, and an explanation of the reasons for
the action. Section 564 of the act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use in a declared emergency. Products appropriate
for emergency use may include products and uses that are not approved,
cleared, or licensed under sections 505, 510(k), and 515 of the act (21
U.S.C. 355, 360(k), and 360e) or section 351 of the Public Health
Service Act (42 U.S.C. 262). FDA may issue an EUA only if, after
consultation with the National Institutes of Health and CDC (to the
extent feasible and appropriate given the circumstances of the
emergency), FDA\1\ concludes: ``(1) that an agent specified in a
declaration of emergency can cause a serious or life-threatening
disease or condition; (2) that, based on the totality of scientific
evidence available to FDA, including data from adequate and well-
controlled clinical trials, if available, it is reasonable to believe
that: (A) the product may be effective in diagnosing, treating, or
preventing--(1) such disease or condition; or (2) a serious or life-
threatening disease or condition caused by a product authorized under
Section 564, approved or cleared under this Act, or licensed under
Section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product; (3) that there is no adequate, approved, and
available alternative to the product for diagnosing, preventing, or
treating such disease or condition; and (4) that such other criteria as
the Secretary may by regulation prescribe are satisfied.''
---------------------------------------------------------------------------
\1\ The Secretary has delegated her authority to issue an EUA
under section 564 of the act to the Commissioner of Food and Drugs.
---------------------------------------------------------------------------
No other criteria of issuance have been prescribed by regulation
under section 564(c)(4) of the act. Because the statute is self-
executing, FDA does not require regulations or guidance to implement
the EUA authority. However, in the Federal Register of July 26, 2007
(72 FR 41083), FDA published a notice of availability of a guidance
entitled ``Emergency Use Authorization of Medical Products'' to provide
more information for stakeholders and the public about the EUA
authority and the agency's process for the consideration of EUA
requests.
II. EUA Request for Peramivir
On April 26, 2009, under section 564(b)(1)(C) of the act (21 U.S.C.
360bbb-3(b)(1)(C)), the then Acting Secretary determined that a public
health emergency exists involving Swine Influenza A (now known as 2009-
H1N1 influenza) that affects, or has the significant potential to
affect, national security. The declaration has been renewed. On October
20, 2009, under section 564(b) of the act, and on the basis of such
determination, the Secretary declared an emergency justifying the
authorization of the emergency use of the antiviral peramivir,
accompanied by emergency use information, subject to the terms of any
authorization issued under 21 U.S.C. 360bbb-3(a). Notice of the
declaration of the Secretary is published elsewhere in this issue of
the Federal Register. On October 23, 2009, CDC requested and FDA issued
the EUA for peramivir 200 mg/ 20 mL (10 mg/mL) single use vial
manufactured for BioCryst for IV administration in certain adult and
pediatric patients, accompanied by emergency use instructions, subject
to the terms and conditions of the authorization.
III. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the Internet at https://www.regulations.gov.
IV. The Authorization
Having concluded that the criteria for issuance of the
Authorizations under section 564(c) of the act are met, FDA has
authorized the emergency use of peramivir 200 mg/ 20 mL (10 mg/mL)
single use vial manufactured for BioCryst for IV administration in
certain adult and pediatric patient, accompanied by emergency use
information, subject to the terms and conditions of the authorization.
The Authorization for peramivir 200 mg/ 20 mL (10 mg/mL) single use
vial manufactured for BioCryst for IV administration follows and
provides an explanation of the reasons for its issuance, as required by
section 564(h)(1) of the act:
[[Page 56646]]
October 23, 2009
Thomas R. Frieden, MD, MPH
Director
Centers for Disease Control and Prevention
1600 Clifton Rd, MS D-14
Atlanta, GA 30333
Dear Dr. Frieden:
This letter is in response to your request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for the emergency use of the unapproved drug peramivir
administered intravenously for treatment of 2009 H1N1 influenza virus (hereafter ``2009 H1N1'') in certain adult and pediatric patients, pursuant to section 564 of the Federal Food, Drug, and
Cosmetic Act (the Act) (21 U.S.C. Sec. 360bbb-3).
On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. Sec. 360bbb-3(b)(1)(C)), the then Acting Secretary of the Department of Health and Human Services (DHHS) determined
that a public health emergency exists involving Swine Influenza A (now referred to as ``2009 H1N1'') that affects or has significant potential to affect national security. The Secretary has
renewed the determination. Pursuant to section 564(b) of the Act (21 U.S.C. Sec. 360bbb-3(b)), and on the basis of such determination, the Secretary of DHHS declared an emergency justifying
the authorization of the emergency use of the antiviral peramivir, accompanied by emergency use information, subject to the terms of any authorization issued under section 564(a) of the Act
(21 U.S.C. Sec. 360bbb-3(a)).
Having consulted with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), and having concluded that the criteria for issuance of this
authorization under section 564(c) of the Act (21 U.S.C. Sec. 360bbb-3(b)) are met, I am authorizing the emergency use of peramivir\1\ administered intravenously for treatment of 2009 H1N1
in certain adult and pediatric patients, subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients meets the criteria for issuance of an
authorization under section 564(c) of the Act, because I have concluded that:
(1) 2009 H1N1 can cause influenza, a serious or life-threatening disease or condition;
(2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that peramivir may be effective when administered intravenously for the treatment of 2009
H1N1 in certain adult and pediatric patients, and that the known and potential benefits of peramivir, when administered intravenously for the treatment of 2009 H1N1 in certain adult and
pediatric patients, outweigh the known and potential risks of peramivir; and
(3) there is no adequate, approved, and available alternative to the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric
patients.\2\
Therefore, I have concluded that the emergency use of peramivir administered intravenously for the treatment of 2009 H1N1 in certain adult and pediatric patients meets the above statutory
criteria for issuance of an authorization.
II. Scope of Authorization
I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is limited to the emergency use of authorized peramivir for the treatment of 2009 H1N1 in
certain adult and pediatric patients. The emergency use of authorized peramivir under this EUA must be consistent with, and may not exceed, the terms of this letter, including the scope and
the conditions of authorization set forth below.
Peramivir (a neuraminidase inhibitor) is an unapproved drug that it is currently being studied in clinical investigations. Peramivir is not currently approved by FDA for any use in the United
States.
The authorized peramivir is as follows:
Peramivir injection: 200mg/20mL (10 mg/mL) single use vial manufactured for BioCryst Pharmaceuticals, Inc. (BioCryst). (See Section IV.D.3. of this letter).
1. The above peramivir product is authorized only for intravenous (IV) administration.
2. The above peramivir product is authorized for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A
virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, the peramivir product is authorized only for the following patients who are admitted to a hospital and under the
care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-
related adverse events):
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
(iii) the clinician judges IV therapy is appropriate due to other circumstances.
b. Pediatric patients for whom an IV agent is clinically appropriate because:
(i) patient not responding to either oral or inhaled antiviral therapy, or
[[Page 56647]]
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible).
3. The above peramivir product may only include product distributed from Strategic National Stockpile (SNS), in which case such product is authorized only to be labeled with the attached
label.
4. The above peramivir product is authorized to be accompanied by the following written information pertaining to the emergency use, which is attached and authorized to be made available to
health care providers and patients (and parents/caregivers):
Fact Sheet for Health Care Provider
Fact Sheet for Patients and Parents/Caregivers
CDC, hospitals, and health care providers receiving authorized peramivir are also authorized to make available additional written information relating to the emergency use of authorized
peramivir that is consistent with and does not exceed the terms of this letter of authorization (including the above referenced facts sheets).
I have concluded, pursuant to section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of authorized peramivir, when used for the treatment of H1N1
in certain adult and pediatric patients, outweigh the known and potential risks of such product.
I have concluded, pursuant to section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that the authorized peramivir may
be effective for the treatment of 2009 H1N1 in certain adult and pediatric patients pursuant to section 564(c)(2)(A) of the Act. FDA has reviewed the scientific information available,
including the information supporting the conclusions described in Section I of this letter above, and concludes that the authorized peramivir when used for the treatment of 2009 H1N1 in
certain adult and pediatric patients, meets the criteria set forth in section 564(c) of the Act concerning safety and potential effectiveness.
Subject to the terms of this EUA and under the circumstances set forth in the Secretary of DHHS's determination under section 564(b)(1)(C) described above and the Secretary of DHHS's
corresponding declaration under section 564(b)(1), the peramivir described above is authorized for the treatment of 2009 H1N1 in certain adult and pediatric patients.
This EUA will cease to be effective when the declaration of emergency is terminated under section 564(b)(2) of the Act or when the EUA is revoked under section 564(g) of the Act.
III. Current Good Manufacturing Practice
This letter covers authorized peramivir as previously manufactured for BioCryst as of the date of this letter as well as authorized peramivir that may be manufactured for BioCryst after such
date, insofar as FDA has determined that the methods used in, and the facilities and controls used for, the manufacturing, processing and packing of authorized peramivir are adequate to
preserve its identity, strength, quality and purity.
Authorized peramivir should be held in accordance with its labeled and appropriate product storage conditions (ambient temperature, 15[deg]C-30[deg]C or 59[deg]F-86[deg]F). However, in order
to ensure the delivery and availability of authorized peramivir, I am waiving current good manufacturing practice (CGMP) requirements with respect to proper storage conditions of temperature
during the shipment and holding of authorized peramivir by CDC and/or its designees for a maximum of 90 days (consecutive or non-consecutive) from the date of shipment to CDC and/or its
designees. Significant excursions from labeled storage conditions should be documented to the extent practicable given the circumstances of the emergency, and need not be supported by
additional testing by CDC or its designees.?
IV. Conditions of Authorization
Pursuant to section 564 of the Act, I am establishing the following conditions on this authorization:
A. CDC
A.1. CDC will decide how authorized peramivir will be distributed under its direction to Hospitals upon request by licensed treating clinicians at the Hospitals to the extent such decisions
are consistent with and do not exceed the terms of this letter; except that CDC will ensure that authorized peramivir will be distributed to Hospitals as soon as possible within 24 hours of
CDC's decision to distribute such product, to the extent practicable given the circumstances of the emergency.
A.2. CDC will maintain adequate records regarding distribution under its direction of authorized peramivir (i.e., lot numbers, quantity, receiving site, receipt date, unique identifier(s)
(e.g., Peramivir Request number(s))).
A.3. CDC will notify FDA on a weekly basis (unless otherwise specified by FDA) of the quantity of and to which Hospitals authorized peramivir is distributed under its direction. CDC will
also include in the notification the unique identifier(s) (e.g., Peramivir Request number(s)).
A.4. CDC will ensure that authorized peramivir is distributed for use under its direction only within the expiry dates identified by FDA. CDC will inform Hospitals receiving authorized
peramivir under its direction of the expiry dates by which authorized peramivir is to be used if authorized peramivir is nearing expiry. CDC will maintain adequate records regarding the
expiry dates by which authorized peramivir is to be used.
A.5. CDC will ensure that Hospitals receiving authorized peramivir under its direction are informed of this letter, including the terms and conditions as well as any authorized amendments
thereto.
[[Page 56648]]
A.6. CDC will make available through appropriate means to the Hospitals receiving authorized peramivir under its direction the authorized Fact Sheet for Health Care Providers and Fact Sheet
for Patients and Parents/Caregivers as well as any authorized amendments thereto.
A.7. CDC will perform adverse event monitoring and compliance activities (e.g., follow-up surveys) designed: (1) to ensure that selected adverse events and all medication errors associated
with the use of authorized peramivir are reported to FDA as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid
FDA Form 3500 (available at https://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-
9787). If there is no online internet access such reports must be made by calling 1-800-FDA-1088; (2) to ensure that such reports include in the description section of the MedWatch Form
3500 the words ``Peramivir EUA'' and include unique identifier(s) (e.g., Peramivir Request number(s)), and (3) to ensure that such reports are made within seven calendar days from the onset
of the event. CDC will report such information to FDA upon request.
A.8. CDC will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed the terms
of this letter (including the facts sheets referenced in Section II of this letter).
A.9. CDC will make available to FDA upon request any records maintained in connection with this letter.
B. Hospitals to Which Authorized Peramivir is Distributed
B.1 Such Hospitals will make available through appropriate means to relevant health care providers this letter, including the terms and conditions as well as any authorized amendments
thereto.
B.2. Such Hospitals will make available through appropriate means to relevant health care providers and patients and/or parents/caregivers the authorized Fact Sheet for Health Care Providers
and Fact Sheet for Patients and Parents/Caregivers as well as any authorized amendments thereto.
B.3. Such Hospitals will ensure that relevant health care providers abide by the institutional procedures regarding drug accountability. Such Hospitals will maintain adequate records showing
receipt, use, and disposition of authorized peramivir.
B.4. Such Hospitals will ensure that the emergency use of authorized peramivir is limited to patients who are under the care or consultation of a licensed clinician (e.g., skilled in the
diagnosis and management of patients with systemic illness, including recognition and management of medication-related adverse events).
B.5. Such Hospitals will conduct any follow-up requested by FDA and/or CDC regarding medication errors and adverse events.
B.6. Such Hospitals will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not exceed
the terms of this letter of authorization (including the facts sheets referenced in Section II of this letter).
B.7. Such Hospitals will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon request, such Hospitals will report to FDA and/or CDC
information with respect to the emergency use of authorized peramivir.
C. Health Care Providers Conducting Activities With Respect to Authorized Peramivir\3\
C.1. Health Care Providers will be aware of this letter, including the terms and conditions as well as any authorized amendments thereto. Health Care Providers will read the Fact Sheet for
Health Care Providers, including the sections on Mandatory Requirements for Peramivir Administration Under Emergency Use Authorization and Considerations Prior to Peramivir Use Under EUA as
well as any amendments thereto. (See Fact Sheet for Health Care Providers).
C.2. Health Care Providers prescribing and/or administering authorized peramivir will ensure that the authorized Fact Sheet for Patients and Parents/Caregivers, as well as any authorized
amendments thereto, have been made available to patients and/or parents/caregivers through appropriate means. Such Health Care Providers (to the extent practicable given the circumstances
of the emergency) will document in the patient's medical record that: (a) patients/caregivers have been given the Fact Sheet for Patients and Parents/Caregivers, (b) patients/caregivers
have been informed of the alternatives to receiving authorized peramivir, and (c) patients/caregivers have been informed that peramivir is an unapproved drug that is authorized for use
under Emergency Use Authorization.
C.3. Prescribing Health Care Providers (or their designees) will ensure that: (1) selected adverse events and all medication errors associated with the use of authorized peramivir are
reported as follows: the MedWatch FDA Form 3500 must be completed either online at www.fda.gov/medwatch/report.htm or by using a postage-paid FDA Form 3500 (available at https://www.fda.gov/medwatch/safety/FDA-3500_fillable.pdf) and returning by fax (1-800-FDA-0178) or by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787). If there is no online internet access such
reports must be made by calling 1-800-FDA-1088; (2) that such reports include in the description section of the MedWatch Form 3500 the words ``Peramivir EUA'' and include unique
identifier(s); and (3) that such reports are made within seven calendar days from the onset of the event. Such Health Care Providers or their designees will conduct any follow-up requested
by FDA and/or CDC.
C.4. Health Care Providers will prescribe and/or administer authorized peramivir only for the treatment of certain patients with suspected or laboratory confirmed 2009 H1N1 infection or
infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, peramivir is authorized only for the following patients who are
admitted to a hospital and under the care or consultation of a licensed clinical (skilled in the diagnosis and management of patients with potentially life-threatening illness and the
ability to recognize and manage medication-related adverse events):
[[Page 56649]]
a. Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
(iii) the clinician judges IV therapy is appropriate due to other circumstances.
b. Pediatric patients for whom an IV agent is clinically appropriate because:
(i) patient not responding to either oral or inhaled antiviral therapy, or
(ii) drug delivery by a route other than IV (e.g., enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible).
C.5. Health Care Providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to peramivir dose calculation and first
administration. (See Fact Sheet For Health Care Providers; Dosage and Administration for Impaired Renal Function Dosing).
C.6. Health Care Providers prescribing and/or administering authorized peramivir will ensure that patients with history of severe allergic reaction to any other neuraminidase inhibitor
(zanamivir or oseltamivir) or any ingredient of peramivir will not receive authorized peramivir. (See Fact Sheet for Health Care Providers; Product Description.)
C.7. Health Care Providers will only make available additional written information relating to the emergency use of authorized peramivir to the extent that it is consistent with and does not
exceed the terms of this letter of authorization (including the facts sheets referenced in Section II of this letter).
C.8. Heath Care Providers will make available to FDA and/or CDC upon request any records maintained in connection with this letter. Upon request, Health Care Providers will report to FDA and/
or CDC information with respect to the emergency use of authorized peramivir.
D. BioCryst
D.1. BioCryst will post on its website the following statement: ``For information about the FDA-authorized emergency use of peramivir, please see www.cdc.gov/h1n1flu/eua.''
D.2. BioCryst will distribute authorized peramivir only to CDC and/or its designees subject to the terms and conditions of this letter.
D.3 BioCryst will contact FDA concerning the need for any FDA review and approval before any changes are made to the manufacturing, packaging, and labeling processes authorized as of the
date of this letter.
D.4. BioCryst (or anyone acting on behalf of BioCryst) will not represent authorized peramivir in a promotional context or otherwise promote authorized peramivir.
D.5. BioCryst will make available to FDA and (as reasonably appropriate) CDC upon request any records maintained in connection with this letter. Upon request, BioCryst will report to FDA and/
or (as reasonably appropriate) CDC information with respect to the emergency use of authorized peramivir.
The emergency use of authorized peramivir as described in this letter of authorization must comply with the conditions above and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration of emergency is terminated under section 564(b)(2) of the Act or the EUA is revoked under section 564(g) of the Act.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
\1\ FDA is authorizing the emergency use of peramivir administered intravenously for treatment of 2009 H1N1 in certain adult and pediatric patients as described in the scope section of this
letter (Section II of this letter). For ease of reference, this letter of authorization will also use the term ``authorized peramivir.''
\2\ No other criteria of issuance have been prescribed by regulation under section 564(c)(4) of the Act.
\3\ The activities with respect to authorized peramivir refer to requesting, preparing, prescribing, and/or administering authorized peramivir, unless otherwise specified.
Dated: October 26, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26291 Filed 10-30-09; 8:45 am]
BILLING CODE 4160-01-S
