Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments, 78929-78930 [2011-32438]

Download as PDF Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0849] Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is seeking comments on specific issues related to its authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require or order safety labeling changes for approved prescription drug products based on new safety information that becomes available after a drug product is approved. The FD&C Act specifies the timeframes within which a safety labeling change must be submitted when required or ordered by the FDA, and timeframes for FDA to conclude its review and take regulatory action regarding safety labeling changes. FDA’s regulations also provide procedures by which labeling changes that do not qualify as changes based on new safety information can be requested by FDA or by the holder of the drug approval. FDA is seeking public input to assist the Agency in establishing specific timeframes for implementing both types of labeling changes. DATES: Submit either electronic or written comments by February 21, 2012. ADDRESSES: Submit electronic comments on this document to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Kristen Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993–0002, (301) 796–0762, Fax: (301) 847–8440. SUPPLEMENTARY INFORMATION: jlentini on DSK4TPTVN1PROD with NOTICES SUMMARY: I. Background On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) was enacted. Title IX, Subtitle A, section 901 of FDAAA added to the FD&C Act new section 505(o) (21 U.S.C. 355(o)), which authorizes FDA to VerDate Mar<15>2010 16:28 Dec 19, 2011 Jkt 226001 require labeling changes when the Agency becomes aware of new safety information it believes should be included in the labeling of an approved drug product.1 Before the enactment of FDAAA, if FDA believed that a labeling change was necessary to address safety information newly identified after approval of a drug product, the Agency would ask the application holder to make the appropriate labeling changes. In most cases, application holders responded to FDA’s requests for labeling changes by negotiating appropriate language with FDA staff to address the concern, and then submitting a supplement or amended supplement to obtain approval of the changes. FDA routinely asked applicants to submit supplemental applications to revise the labeling of approved products, but the Agency lacked the authority to compel changes to product labeling based on new safety information. At times, FDA and application holders discussed the appropriate timeframe by which new labeling would be made available. Typically products that had already moved beyond the manufacturing line were not withdrawn from distribution to change existing labeling under the timeframes. Under FDAAA, FDA is now authorized to require and, if necessary, order application holders to implement safety labeling changes to reflect new safety information (section 505(o)(4) of the FD&C Act). Although the statute provides specific and relatively short timelines for submission and review of FDAAA-required safety labeling changes following a notification or order from FDA, the statute does not include specific deadlines for how soon the revised labeling must be incorporated into the packaging of the product that is offered for sale, or into other labeling (section 505(o)(4) of the FD&C Act). In an effort to make revised safety labeling available as soon as possible after the changes required under FDAAA are approved, FDA has recommended that application holders post the revised labeling on their Web sites within 10 days of approval. (See draft guidance for industry entitled ‘‘Safety Labeling Changes— Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act’’ (76 FR 20686, April 13, 2011)). In letters approving supplements with safety labeling changes, FDA has also 1 For purposes of this notice, drug product means a human drug product including a biological drug product. Labeling includes the carton or other container or packaging labels, the prescribing information, patient package inserts, and Medication Guides. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 78929 recommended that revised labeling accompany the product within ‘‘a reasonable amount of time’’ and has occasionally suggested specific timeframes when this could occur. However, we have not yet announced general timeframes in which we expect new labeling to be disseminated nor have we established the timeframe for when product packaging needs to reflect the revised label. In addition to safety labeling changes that may be required under FDAAA, FDA may continue to request safety labeling changes under existing regulations and application holders may continue to propose labeling changes on their own initiative (§§ 314.70 and 601.12 (21 CFR 314.70 and 601.12)). Existing regulations in §§ 314.70 and 601.12 describe several mechanisms for effecting proposed labeling changes to approved drug applications including the following: (1) A prior approval supplement (PAS) is used for changes that must receive approval before being implemented; (2) a changes-beingeffected supplement (CBE) is used for other kinds of labeling revisions that must be received by the Agency prior to distribution of the drug with the revised labeling; and (3) the annual report for the drug product is used for certain minor changes that need only be described in the next annual report. Current labeling regulations do not provide specific timeframes for implementing other safety labeling changes—changes not required under FDAAA—that are made by submitting a PAS or CBE, or by reporting the change in the annual report. II. Purpose of Request for Comments Because safety labeling changes may be related to serious risks, this information must be promptly communicated to prescribers and patients. Thus, it is important for FDA to clarify its expectations regarding the timeframes for applicants to implement safety labeling changes to ensure that the labeling is updated in a timely manner. FDA anticipates that in most cases, as in the past, it will not be necessary for products with existing labeling to be withdrawn from distribution and that under certain circumstances it may be appropriate for products with existing labeling to remain in distribution until the current product inventory is exhausted. FDA is interested in hearing from application holders, manufacturers, distributors, and other stakeholders about their experience with and views on the practical implementation of revised product labeling, including their views as to how factors in the following E:\FR\FM\20DEN1.SGM 20DEN1 78930 Federal Register / Vol. 76, No. 244 / Tuesday, December 20, 2011 / Notices three categories may affect implementation: (1) Drug manufacturing and packaging, and printing labels and other labeling; (2) supply chain issues; and, (3) other issues. FDA may use the information received to develop draft guidance for industry regarding timeframes for revising product labeling following the approval of safety labeling changes, and may apply these timeframes to particular safety labeling changes. III. Questions Posed by FDA With this notice, FDA is soliciting comments from application holders, manufacturers, distributors, and other stakeholders on the following questions: A. Considerations Related to Drug Manufacturing and Packaging, and to Printing Labeling newly shipped product) and the type of labeling change. 8. Are there other considerations or options related to implementing safety labeling changes of which FDA should be aware? IV. Comments Interested persons may submit either electronic or written comments regarding this document to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, as well as at https://www.regulations.gov. 1. What are the considerations related to drug manufacturing and packaging, of which FDA should be aware, as they relate to implementation of revised product labeling? 2. What are the considerations related to printing labels and other types of labeling of which FDA should be aware, as they relate to implementation of different types of revised product labeling? Dated: December 14, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. B. Supply Chain Issues [Docket No. FDA–2011–D–0476] 3. What are the supply chain factors (including storage, shipping, and distribution factors) of which FDA should be aware that limit or otherwise affect how quickly a labeling change can be implemented? Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability jlentini on DSK4TPTVN1PROD with NOTICES C. Other Considerations 16:28 Dec 19, 2011 BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration AGENCY: 4. What alternative labeling mechanisms (e.g., having labeling available on a product Web site) could be used to disseminate new safety information quickly to patients and health care providers? 5. How should the relative seriousness of the new safety information, or whether the new safety information describes a newly identified risk, or strengthens a risk already identified in current labeling, affect timelines for implementing revised product labeling? 6. What are the implementation considerations when the safety labeling change is to prescriber versus patient labeling (or both)? 7. What would be a reasonable timeframe following approval of revised safety related labeling changes for applicants to implement the revised labeling? Please relate this timeframe to the optimal point in the supply chain (e.g., newly manufactured product, VerDate Mar<15>2010 [FR Doc. 2011–32438 Filed 12–19–11; 8:45 am] Jkt 226001 Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.’’ This document describes FDA’s intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Radiology Devices’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to (301) 847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5543, Silver Spring, MD 20993–0002, (301) 796–6217. SUPPLEMENTARY INFORMATION: I. Background FDA has identified certain Class I and Class II in vitro diagnostic and radiology devices that have established safety and effectiveness profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would reclassify the Class II devices and amend the classification regulations of the Class I devices, FDA no longer believes it is necessary to review premarket notification (510(k)) submissions for these devices before they enter the market. FDA is issuing a guidance concerning a policy of exercising enforcement discretion with regard to the 510(k) requirement for such devices. The guidance lists the devices for which FDA intends to exercise enforcement discretion with regard to premarket notification requirements, subject to the limitations to the exemption criteria found in 21 CFR 862.9, 21 CFR 864.9, 21 CFR 866.9, and 21 CFR 892.9. FDA intends to continue to enforce all other applicable requirements under the FD&C Act, including, but not limited to: Registration and listing (part 807 (21 CFR part 807)); labeling (part 801 (21 CFR part 801) and § 809.10 (21 CFR 809.10)); good manufacturing practice requirements as set forth in the Quality System regulation (part 820 (21 CFR part 820)); and Medical Device Reporting requirements (part 803 (21 E:\FR\FM\20DEN1.SGM 20DEN1

Agencies

[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Pages 78929-78930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32438]

[[Page 78929]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0849]

Establishing Timeframes for Implementation of Product Safety
Labeling Changes; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is seeking comments on
specific issues related to its authority under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to require or order safety labeling
changes for approved prescription drug products based on new safety
information that becomes available after a drug product is approved.
The FD&C Act specifies the timeframes within which a safety labeling
change must be submitted when required or ordered by the FDA, and
timeframes for FDA to conclude its review and take regulatory action
regarding safety labeling changes. FDA's regulations also provide
procedures by which labeling changes that do not qualify as changes
based on new safety information can be requested by FDA or by the
holder of the drug approval. FDA is seeking public input to assist the
Agency in establishing specific timeframes for implementing both types
of labeling changes.

DATES: Submit either electronic or written comments by February 21,
2012.

ADDRESSES: Submit electronic comments on this document to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. All comments should be identified with
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kristen Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, (301)
796-0762, Fax: (301) 847-8440.

SUPPLEMENTARY INFORMATION:

I. Background

On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA) was enacted. Title IX, Subtitle A, section 901 of
FDAAA added to the FD&C Act new section 505(o) (21 U.S.C. 355(o)),
which authorizes FDA to require labeling changes when the Agency
becomes aware of new safety information it believes should be included
in the labeling of an approved drug product.\1\
---------------------------------------------------------------------------

\1\ For purposes of this notice, drug product means a human drug
product including a biological drug product. Labeling includes the
carton or other container or packaging labels, the prescribing
information, patient package inserts, and Medication Guides.
---------------------------------------------------------------------------

Before the enactment of FDAAA, if FDA believed that a labeling
change was necessary to address safety information newly identified
after approval of a drug product, the Agency would ask the application
holder to make the appropriate labeling changes. In most cases,
application holders responded to FDA's requests for labeling changes by
negotiating appropriate language with FDA staff to address the concern,
and then submitting a supplement or amended supplement to obtain
approval of the changes. FDA routinely asked applicants to submit
supplemental applications to revise the labeling of approved products,
but the Agency lacked the authority to compel changes to product
labeling based on new safety information. At times, FDA and application
holders discussed the appropriate timeframe by which new labeling would
be made available. Typically products that had already moved beyond the
manufacturing line were not withdrawn from distribution to change
existing labeling under the timeframes.
Under FDAAA, FDA is now authorized to require and, if necessary,
order application holders to implement safety labeling changes to
reflect new safety information (section 505(o)(4) of the FD&C Act).
Although the statute provides specific and relatively short timelines
for submission and review of FDAAA-required safety labeling changes
following a notification or order from FDA, the statute does not
include specific deadlines for how soon the revised labeling must be
incorporated into the packaging of the product that is offered for
sale, or into other labeling (section 505(o)(4) of the FD&C Act).
In an effort to make revised safety labeling available as soon as
possible after the changes required under FDAAA are approved, FDA has
recommended that application holders post the revised labeling on their
Web sites within 10 days of approval. (See draft guidance for industry
entitled ``Safety Labeling Changes--Implementation of Section 505(o)(4)
of the Federal Food, Drug, and Cosmetic Act'' (76 FR 20686, April 13,
2011)). In letters approving supplements with safety labeling changes,
FDA has also recommended that revised labeling accompany the product
within ``a reasonable amount of time'' and has occasionally suggested
specific timeframes when this could occur. However, we have not yet
announced general timeframes in which we expect new labeling to be
disseminated nor have we established the timeframe for when product
packaging needs to reflect the revised label.
In addition to safety labeling changes that may be required under
FDAAA, FDA may continue to request safety labeling changes under
existing regulations and application holders may continue to propose
labeling changes on their own initiative (Sec. Sec. 314.70 and 601.12
(21 CFR 314.70 and 601.12)). Existing regulations in Sec. Sec. 314.70
and 601.12 describe several mechanisms for effecting proposed labeling
changes to approved drug applications including the following: (1) A
prior approval supplement (PAS) is used for changes that must receive
approval before being implemented; (2) a changes-being-effected
supplement (CBE) is used for other kinds of labeling revisions that
must be received by the Agency prior to distribution of the drug with
the revised labeling; and (3) the annual report for the drug product is
used for certain minor changes that need only be described in the next
annual report.
Current labeling regulations do not provide specific timeframes for
implementing other safety labeling changes--changes not required under
FDAAA--that are made by submitting a PAS or CBE, or by reporting the
change in the annual report.

II. Purpose of Request for Comments

Because safety labeling changes may be related to serious risks,
this information must be promptly communicated to prescribers and
patients. Thus, it is important for FDA to clarify its expectations
regarding the timeframes for applicants to implement safety labeling
changes to ensure that the labeling is updated in a timely manner. FDA
anticipates that in most cases, as in the past, it will not be
necessary for products with existing labeling to be withdrawn from
distribution and that under certain circumstances it may be appropriate
for products with existing labeling to remain in distribution until the
current product inventory is exhausted.
FDA is interested in hearing from application holders,
manufacturers, distributors, and other stakeholders about their
experience with and views on the practical implementation of revised
product labeling, including their views as to how factors in the
following

[[Page 78930]]

three categories may affect implementation: (1) Drug manufacturing and
packaging, and printing labels and other labeling; (2) supply chain
issues; and, (3) other issues. FDA may use the information received to
develop draft guidance for industry regarding timeframes for revising
product labeling following the approval of safety labeling changes, and
may apply these timeframes to particular safety labeling changes.

III. Questions Posed by FDA

With this notice, FDA is soliciting comments from application
holders, manufacturers, distributors, and other stakeholders on the
following questions:

A. Considerations Related to Drug Manufacturing and Packaging, and to
Printing Labeling

1. What are the considerations related to drug manufacturing and
packaging, of which FDA should be aware, as they relate to
implementation of revised product labeling?
2. What are the considerations related to printing labels and other
types of labeling of which FDA should be aware, as they relate to
implementation of different types of revised product labeling?

B. Supply Chain Issues

3. What are the supply chain factors (including storage, shipping,
and distribution factors) of which FDA should be aware that limit or
otherwise affect how quickly a labeling change can be implemented?

C. Other Considerations

4. What alternative labeling mechanisms (e.g., having labeling
available on a product Web site) could be used to disseminate new
safety information quickly to patients and health care providers?
5. How should the relative seriousness of the new safety
information, or whether the new safety information describes a newly
identified risk, or strengthens a risk already identified in current
labeling, affect timelines for implementing revised product labeling?
6. What are the implementation considerations when the safety
labeling change is to prescriber versus patient labeling (or both)?
7. What would be a reasonable timeframe following approval of
revised safety related labeling changes for applicants to implement the
revised labeling? Please relate this timeframe to the optimal point in
the supply chain (e.g., newly manufactured product, newly shipped
product) and the type of labeling change.
8. Are there other considerations or options related to
implementing safety labeling changes of which FDA should be aware?

IV. Comments

Interested persons may submit either electronic or written comments
regarding this document to the Division of Dockets Management (see
ADDRESSES). It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, as well as
at https://www.regulations.gov.

Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32438 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P

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