Workshop on Pet Medications Issues, 40355-40358 [2012-16594]

Download as PDF sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices either electronically in www.regulations.gov or in hard copy at the OW Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OW Docket is (202) 566– 2426. FOR FURTHER INFORMATION CONTACT: Sherri Comerford, Underground Injection Control (UIC) Program, Drinking Water Protection Division, Office of Ground Water and Drinking Water (MC–4606M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564–4639; email address: Comerford.Sherri@epa.gov. For general information, visit the Underground Injection Control Program’s Hydraulic Fracturing and the Safe Drinking Water Act Web site, https://water.epa.gov/type/ groundwater/uic/class2/ hydraulicfracturing/hydraulicfracturing.cfm. SUPPLEMENTARY INFORMATION: Underground injection of fluids through wells is subject to the requirements of the Safe Drinking Water Act (SDWA) except where specifically excluded by the statute. In the 2005 Energy Policy Act (EP Act), Congress revised the SDWA definition of ‘‘underground injection’’ to specifically exclude from UIC regulation the ‘‘underground injection of fluids or propping agents (other than diesel fuels) pursuant to hydraulic fracturing operations related to oil, gas, or geothermal production activities’’ (SDWA Section 1421(d)(1)(B)). UIC regulations further provide that ‘‘[a]ny underground injection, except into a well authorized by rule or except as authorized by permit issued under the UIC program, is prohibited’’ (40 CFR 144.11). Thus, owners or operators who inject diesel fuels during hydraulic fracturing related to oil, gas, or geothermal operations must obtain a UIC permit before injection begins. While the EP Act references hydraulic fracturing related to geothermal activities, the draft guidance only covers hydraulic fracturing using diesel fuels related to oil and gas activities. Permits for oil and gas hydraulic fracturing using diesel fuels are available through the UIC Class II Program, the well class for oil and gas activities. Geothermal activities are not considered Class II. The draft guidance provides information on SDWA UIC Class II VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 requirements and recommendations for permitting hydraulic fracturing injection wells where diesel fuels are used in fluids or propping agents. The draft guidance is intended for EPA permit writers and, as a result, is relevant where EPA directly implements the UIC Class II program. Others may find the information in this document useful also. Recommendations in the draft guidance may change based on the comments we receive on the draft publication and this will be reflected in the final guidance. The deadline for submitting comments is August 23, 2012. Dated: July 3, 2012. Pamela S. Barr, Acting Director, Office of Ground Water and Drinking Water. [FR Doc. 2012–16694 Filed 7–6–12; 8:45 am] BILLING CODE 6560–50–P FEDERAL ELECTION COMMISSION Sunshine Act Meeting Federal Election Commission. Thursday, July 12, 2012 at 10:00 a.m. PLACE: 999 E Street NW., Washington, DC (Ninth Floor). STATUS: This Meeting Will Be Open to the Public. AGENCY: DATE AND TIME: Items To Be Discussed Correction and Approval of the Minutes for the Meeting of June 21, 2012; Proposed Final Audit Report on National Right to Life PAC (A09–19); Management and Administrative Matters. Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694–1040, at least 72 hours prior to the meeting date. PERSON TO CONTACT FOR INFORMATION: Judith Ingram, Press Officer, Telephone: (202) 694–1220. Shelley E. Garr, Deputy Secretary of the Commission. [FR Doc. 2012–16841 Filed 7–5–12; 4:15 pm] BILLING CODE 6715–01–P FEDERAL TRADE COMMISSION Workshop on Pet Medications Issues Federal Trade Commission. Notice of workshop and request for comments. AGENCY: ACTION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 40355 The Federal Trade Commission seeks public comments in connection with a workshop to examine competition and consumer protection issues in the pet medications industry. The workshop will consider how current industry distribution and other business practices affect consumer choice and price competition for pet medications; the ability of consumers to obtain written, portable prescriptions that they can fill wherever they choose; and the ability of consumers to verify the safety and efficacy of pet medications that they purchase. The workshop will also examine the extent to which recent changes to restricted distribution and prescription portability practices in the contact lens industry might yield lessons applicable to the pet medications industry. The Commission seeks the views of consumers, veterinarians, business representatives, economists, lawyers, academics, and other interested parties on these issues. This notice poses a series of questions relevant to those issues about which the Commission seeks comment. After conducting the workshop and reviewing comments, the Commission may prepare a report discussing these issues. DATES: The workshop will be held on October 2, 2012, in the Conference Center of the FTC office building at 601 New Jersey Avenue NW., Washington, DC. Prior to the workshop, the Commission will publish an agenda and further information on its Web site. Comments in response to this notice must be received on or before September 14, 2012. ADDRESSES: Interested parties are invited to submit written comments electronically or in paper form by following the instructions in the SUPPLEMENTARY INFORMATION section below. Comments in electronic form should be submitted by using the following Web link: https:// ftcpublic.commentworks.com/ftc/ petmedsworkshop (and following the instructions on the Web-based form). Comments filed in paper form should be mailed or delivered to the following address: Federal Trade Commission, Office of the Secretary, Room H–113 (Annex X), 600 Pennsylvania Avenue NW., Washington, DC 20580, in the manner detailed in the supplementary section below. FOR FURTHER INFORMATION CONTACT: Stephanie A. Wilkinson, Attorney, Office of Policy Planning, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580, 202–326– 2084, petmedsworkshop@ftc.gov. SUPPLEMENTARY INFORMATION: The quality and cost of pet medications is an SUMMARY: E:\FR\FM\09JYN1.SGM 09JYN1 40356 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices important pocketbook issue for many consumers. In 2011, 62 percent of U.S. households owned a pet, and Americans spent an estimated $50 billion on their pets,1 including nearly $7 billion for prescription and over-the-counter (OTC) pet medications.2 Drawing on the Federal Trade Commission’s expertise as a competition and consumer protection agency, the workshop will examine ways to inform and empower consumers to obtain the highest quality and most cost-effective healthcare products for their pets. Pet owners spend significantly more money on their pets than in past decades, and the market for pet medications has grown significantly in recent years.3 Manufacturers and veterinarians have introduced new and improved diagnostic and therapeutic treatments for pets; pet medications have become available at some online and brick-and-mortar retail outlets; and veterinarians and others have increasingly emphasized preventative pet care. In addition, market participants note, in recent years it has become easier to administer flea and tick control products and heartworm preventatives, and the products themselves have become more effective. These products comprise the bulk of chronic pet medications sold in the United States. Indeed, the sale of prescription and OTC flea, tick, and heartworm products totaled nearly $3.7 billion in 2011.4 Distribution Practices in the Pet Medications Industry sroberts on DSK5SPTVN1PROD with NOTICES Historically, veterinarians have been the principal dispensers of pet medications because of their unique role in the veterinarian-client-patient relationship, whereby a veterinarian examines, diagnoses, and treats the animal (patient), while also providing information to the animal’s owner (client). Consumers still purchase most of their pet medications from the veterinarians who examine their pets, and most pet medication manufacturers choose to distribute their products 1 American Pet Products Association Industry Statistics & Trends. 2 Packaged Facts estimates. 3 The size of the overall U.S. pet industry grew steadily from $17 billion in 1994 to over $50 billion in 2011. (American Pet Products Association Industry Statistics & Trends.) The size of the U.S. pet medications market grew from approximately $4.5 billion in 2006 to approximately $6.7 billion in 2011, and is projected to reach $9.25 billion by 2015. (Packaged Facts estimates.) 4 Id. Of the estimated $6.7 billion in U.S. retail sales of pet medications in 2011, 36% was for flea and tick control products, and 19% was for heartworm preventatives. (Packaged Facts estimates.) VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 exclusively through the veterinary channel. Nonetheless, pet medications are no longer sold exclusively by veterinarians. Over the last ten years, brick-and-mortar and online retail and pharmacy entities (hereinafter collectively referred to as ‘‘retailers’’) also have begun selling pet medications, especially OTC medications. Some evidence suggests that these retailers may offer substantial pro-consumer benefits, such as increased convenience and lower prices. Although retailers may obtain some portion of their pet medication products directly from manufacturers or authorized distributors, they also rely heavily on secondary supply channels. Most manufacturers state that they restrict the distribution of their pet medications to the veterinary channel, and that they use well-established tracking procedures to ensure the safety and efficacy of their products. Certain veterinarians purchase pet medications from manufacturers or authorized distributors and then resell some portion of their purchase to secondary suppliers for a profit, a practice sometimes referred to as ‘‘diversion.’’ 5 Some secondary suppliers and retailers claim to have protocols in place to verify that the retailers receive bona fide products that originated with the manufacturer. Other industry participants, however, have questioned whether secondary suppliers and retailers always receive bona fide products (as compared to, for example, counterfeit product from non-U.S. sources), thereby raising potential questions about product safety and authenticity. The workshop will examine how competition in sales of pet medications to consumers has developed in light of these practices and how prices, product supply, and product quality may be affected. In the workshop, the Commission seeks to examine issues related to the distribution of pet medications from practical, economic, and legal perspectives. The Commission invites public comment on questions relevant to this topic, including: • How are pet medications distributed to consumers? • What are the business rationales for various pet medication distribution practices? 5 It should be noted that the term ‘‘diversion’’ as used in human pharmaceutical markets means the illegal trade in prescription narcotics, in which products are not being used by the consumer in the manner intended. This is distinct from the situation in the pet medications market, in which products obtained through secondary supply channels are being used by the consumer in the manner intended. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 • How has competition to sell medications to pet owners evolved in light of these distribution practices? • How do these practices affect prices to consumers? • How do these practices affect product supply and quality? • How do these practices affect consumer choice? • How do these practices affect entry into the pet medications market? • How do these practices affect innovation in the pet medications market? • What efficiencies or inefficiencies are associated with these practices? • What, if any, product safety or counterfeiting issues exist with respect to these practices? Have there been instances in which false or misleading information about product safety risks was disseminated to consumers? • Are there other factors that should be considered when analyzing the competition and consumer protection issues related to the distribution of pet medications? Prescription Portability for Pet Medications All industry participants agree that pets should be properly examined and diagnosed by a veterinarian to determine the most appropriate course of treatment for any medical condition, including whether any medication should be prescribed. When a veterinarian writes a prescription for a medication to be dispensed and subsequently administered by a pet’s owner, the prescription must be filled with the correct medication and dosage and the owner must have access to relevant information about the medication and proper administration techniques. Some observers argue that veterinarians are in the best position to carry out these responsibilities; these observers believe, therefore, that veterinarians alone should dispense prescription pet medications to their clients. Others argue that licensed pharmacists are equally capable of dispensing pet medications to consumers, provided the pharmacists dispense the correct medication and dosage as prescribed by a veterinarian; these advocates point out that veterinarians can still provide relevant information and follow-up care to their clients even if they do not dispense the medication. Concerns about the safety of pet medications dispensed by pharmacists appear less pronounced for OTC medications, which do not require a prescription and typically do not require direct supervision by a veterinarian. E:\FR\FM\09JYN1.SGM 09JYN1 sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices A consumer cannot legally obtain prescription pet medications from a retailer without a written, portable prescription from a veterinarian. The American Veterinary Medical Association (AVMA) advises veterinarians to honor a client’s request for a prescription, provided that a valid veterinarian-client-patient relationship exists.6 This guidance is not mandatory, however. State regulations vary as to whether veterinarians are legally required to provide written prescriptions to clients, and it is unclear to what extent such regulatory obligations may be actively enforced against veterinarians. It appears that, while many veterinarians provide written prescriptions to their clients when requested, some veterinarians have refused to provide prescriptions or otherwise have discouraged their clients from obtaining pet medications from retailers. Federal legislation proposed in House Bill 1406 (‘‘H.R. 1406’’ or ‘‘the Bill’’) would require veterinarians to provide clients with written prescriptions for all pet medications, regardless of whether requested, and to inform clients of their right to have pet medications dispensed elsewhere.7 The Bill also would prohibit veterinarians from charging a fee or requiring waivers of liability for providing written prescriptions. H.R. 1406 would require the Federal Trade Commission to promulgate rules implementing the statute within 180 days of its enactment. In the workshop, the Commission seeks to examine issues related to the portability of pet medication prescriptions from practical, economic, and legal perspectives. The Commission invites public comment on questions relevant to this topic, including: • How varied are current veterinarian practices with respect to providing written, portable prescriptions to clients? • To what extent are consumers aware that they can request a portable prescription from their veterinarian and have the prescription dispensed elsewhere? • Which states require prescription portability for pet medications? Which do not? Are there states in which a proposal for prescription portability for pet medications was rejected by the legislature and, if so, why? • In states that do require prescription portability, what recourse 6 See Principles of Veterinary Medical Ethics of the AVMA, III.C.1. 7 See Fairness to Pet Owners Act, H.R. 1406, 112th Cong. (2011), available at https:// www.gpo.gov/fdsys/pkg/BILLS–112hr1406ih/pdf/ BILLS–112hr1406ih.pdf. VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 do consumers have if a veterinarian refuses to provide a written, portable prescription? • What evidence exists to support a need for federal legislation requiring veterinarians to provide written prescriptions to their clients? • What price and non-price benefits can accrue to consumers from prescription portability for pet medications? • What risks or inefficiencies may be posed by prescription portability for pet medications? • Is there a need for federal legislation requiring veterinarians to notify clients that they have the right to fill their prescriptions at the pharmacy of their choice? • Is it appropriate to deny veterinarians the ability to charge a fee or require a waiver of liability for providing a written prescription to clients? • How might the passage of H.R. 1406 affect price, consumer choice, and other forms of competition in the pet medications market? • How can the prices charged to consumers for pet medications by veterinary clinics and retailers best be quantified and compared? • To what extent do retailer prices for pet medications affect the prices of medications sold at veterinary practices, or other aspects of veterinary clinic operations? • To what extent would H.R. 1406 affect veterinarians’ sales of pet medications? • What compliance costs would veterinarians face if H.R. 1406 were enacted? • How might the passage of H.R. 1406 affect pet medication distribution practices? • Should possible amendments to H.R. 1406 be considered? • Are there other factors that should be considered when analyzing the competition and consumer protection issues related to the portability of pet medication prescriptions? Comparison to Fairness to Contact Lens Consumers Act Some restricted distribution and prescription portability issues existed in the contact lens industry at the time that Congress passed the Fairness to Contact Lens Consumers Act (‘‘FCLCA’’), Public Law 108–164. Industry participants have noted both similarities and differences between the contact lens industry and the pet medications industry. The workshop will examine whether consumer experiences with the FCLCA might provide insights about the potential impact of H.R. 1406. The PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 40357 Commission invites public comment on questions relevant to this topic, including: • What was the impact of the FCLCA, if any, to consumers? • What was the impact of the FCLCA, if any, to optometrists and ophthalmologists? • What was the impact of the FCLCA, if any, on entry into the contact lens industry? • What was the impact of the FCLCA, if any, on innovation in the contact lens industry? • What was the impact of the FCLCA, if any, to contact lens distribution practices? • Are there significant similarities or differences between the contact lens industry and the pet medications industry, particularly with respect to industry distribution practices and issues of prescription portability? If so, how should those similarities or differences be taken into account in assessing the likely effects of H.R. 1406 compared to the FCLCA? • Are there other factors that should be considered when analyzing the competition and consumer protection issues related to the FCLCA, and how consumer experiences with the FCLCA might provide insights about the potential impact of H.R. 1406? Instructions for Filing Public Comments Interested parties are invited to submit written comments electronically or in paper form. We must receive your comment by September 14, 2012. Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please consider submitting your comments in electronic form. Comments filed in electronic form should be submitted using the following Web link: https:// ftcpublic.commentworks.com/ftc/ petmedsworkshop (and following the instructions on the Web-based form). To ensure that the Commission considers an electronic comment, you must file it on the Web-based form at the Web link: https://ftcpublic.commentworks.com/ ftc/petmedsworkshop. If this notice appears at https://www.regulations.gov/ #!home, you may also file an electronic comment through that Web site. The Commission will consider all comments that regulations.gov forwards to it. You may also visit the FTC Web site at https://www.ftc.gov to read the notice and the news release describing it. Comments should refer to ‘‘Pet Medications Workshop, Project No. P12–1201’’ to facilitate the organization of comments. Please note that your comment—including your name and your State—will be placed on the public E:\FR\FM\09JYN1.SGM 09JYN1 40358 Federal Register / Vol. 77, No. 131 / Monday, July 9, 2012 / Notices sroberts on DSK5SPTVN1PROD with NOTICES record of this proceeding, including on the publicly accessible FTC Web site, at https://www.ftc.gov/os/ publiccomments.shtm. Because comments will be made public, they should not include any sensitive personal information, such as any individual’s Social Security Number; date of birth; driver’s license number or other State identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include ‘‘trade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential’’ as provided in Section 6(f) of the Federal Trade Commission Act (FTC Act), 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c).8 A comment filed in paper form should include the ‘‘Pet Medications Workshop, Project No. P12–1201’’ reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission, Office of the Secretary, Room H–113 (Annex X), 600 Pennsylvania Avenue NW., Washington, DC 20580. The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives, whether filed in paper or electronic form. Comments received will be available to the public on the FTC Web site, to the extent practicable, at https://www.ftc.gov/os/ publiccomments.shtm. As a matter of discretion, the FTC makes every effort to remove home contact information for 8 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR 4.9(c). VerDate Mar<15>2010 16:20 Jul 06, 2012 Jkt 226001 individuals from the public comments it receives before placing those comments on the FTC Web site. More information, including routine uses permitted by the Privacy Act, may be found in the FTC’s privacy policy, at https://www.ftc.gov/ ftc/privacy.htm. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2012–16594 Filed 7–6–12; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Meeting announcement and request for comments. AGENCY: Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of a meeting of SACATM on September 5–6, 2012, at the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. The meeting is open to the public with attendance limited only by the space available. The meeting will be webcast through a link at (https:// www.niehs.nih.gov/news/video/live). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. DATES: The SACATM meeting will be held on September 5–6, 2012. The meeting is tentatively scheduled from 8:30 a.m. Eastern Daylight Time to 5:30 p.m. on September 5 and 8:30 a.m. until adjournment on September 6. All individuals who plan to attend are encouraged to register online at the NTP Web site (https://ntp.niehs.nih.gov/go/ 32822) by August 29, 2012. In order to facilitate planning, persons wishing to make an oral presentation are asked to notify Dr. Lori White, NTP Designated Federal Officer, via online registration, phone, or email by August 29, 2012 (see ADDRESSES below). Written comments should also be received by August 29, 2012, to enable review by SACATM and NIEHS/DNTP staff before the meeting. TTY users should contact the Federal TTY Relay Service at 800–877–8339. Requests should be made at least 5 business days in advance of the event. ADDRESSES: The SACATM meeting will be held at the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. Public comments and other correspondence should be directed to Dr. Lori White (Office of Liaison, Policy and Review, DNTP, NIEHS, P.O. Box 12233, MD K2–03, SUMMARY: GENERAL SERVICES ADMINISTRATION [FMR Bulletin—PBS–2012–03; Docket 2012– 0002; Sequence 11] Federal Management Regulation; FMR Bulletin PBS–2012–03; Redesignations of Federal Buildings: Correction Public Buildings Service (PBS), General Services Administration (GSA). ACTION: Notice of a bulletin; correction. AGENCY: The U.S. General Services Administration published in the Federal Register of June 13, 2012, a bulletin announcing the designation and redesignation of three Federal buildings. Inadvertently, the two-letter State ‘‘AL’’ was incorrectly identified with the city of Anchorage. This document corrects the abbreviation of the State of Anchorage to ‘‘AK’’. DATES: Effective Date: July 9, 2012. FOR FURTHER INFORMATION CONTACT: U.S. General Services Administration, Public Buildings Service (PBS), 1800 F Street NW., Washington, DC 20405, telephone number: 202–501–1100. SUPPLEMENTARY INFORMATION: The GSA published a document in the Federal Register of June 13, 2012, (77 FR 35393). Inadvertently, the two-letter State for the city Anchorage was identified incorrectly. This document corrects the abbreviation of the State for the city Anchorage to read ‘‘AK’’. SUMMARY: Correction In FR Doc. 2012–14416 published in the Federal Register at 77 FR 35393, June 13, 2012 make the following correction: On page 35393, in the table, first and second columns, second entries, remove ‘‘Anchorage, AL’’ and add ‘‘Anchorage, AK’’ in their places. Dated: June 21, 2012. Dan Tangherlini, Acting Administrator of General Services. [FR Doc. 2012–16712 Filed 7–6–12; 8:45 am] BILLING CODE 6820–23–P PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 77, Number 131 (Monday, July 9, 2012)]
[Notices]
[Pages 40355-40358]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16594]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION


Workshop on Pet Medications Issues

AGENCY: Federal Trade Commission.

ACTION: Notice of workshop and request for comments.

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

SUMMARY: The Federal Trade Commission seeks public comments in 
connection with a workshop to examine competition and consumer 
protection issues in the pet medications industry. The workshop will 
consider how current industry distribution and other business practices 
affect consumer choice and price competition for pet medications; the 
ability of consumers to obtain written, portable prescriptions that 
they can fill wherever they choose; and the ability of consumers to 
verify the safety and efficacy of pet medications that they purchase. 
The workshop will also examine the extent to which recent changes to 
restricted distribution and prescription portability practices in the 
contact lens industry might yield lessons applicable to the pet 
medications industry. The Commission seeks the views of consumers, 
veterinarians, business representatives, economists, lawyers, 
academics, and other interested parties on these issues. This notice 
poses a series of questions relevant to those issues about which the 
Commission seeks comment. After conducting the workshop and reviewing 
comments, the Commission may prepare a report discussing these issues.

DATES: The workshop will be held on October 2, 2012, in the Conference 
Center of the FTC office building at 601 New Jersey Avenue NW., 
Washington, DC. Prior to the workshop, the Commission will publish an 
agenda and further information on its Web site. Comments in response to 
this notice must be received on or before September 14, 2012.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form by following the instructions in the 
SUPPLEMENTARY INFORMATION section below. Comments in electronic form 
should be submitted by using the following Web link: https://ftcpublic.commentworks.com/ftc/petmedsworkshop (and following the 
instructions on the Web-based form). Comments filed in paper form 
should be mailed or delivered to the following address: Federal Trade 
Commission, Office of the Secretary, Room H-113 (Annex X), 600 
Pennsylvania Avenue NW., Washington, DC 20580, in the manner detailed 
in the supplementary section below.

FOR FURTHER INFORMATION CONTACT: Stephanie A. Wilkinson, Attorney, 
Office of Policy Planning, Federal Trade Commission, 600 Pennsylvania 
Avenue NW., Washington, DC 20580, 202-326-2084, 
petmedsworkshop@ftc.gov.

SUPPLEMENTARY INFORMATION: The quality and cost of pet medications is 
an

[[Page 40356]]

important pocketbook issue for many consumers. In 2011, 62 percent of 
U.S. households owned a pet, and Americans spent an estimated $50 
billion on their pets,\1\ including nearly $7 billion for prescription 
and over-the-counter (OTC) pet medications.\2\ Drawing on the Federal 
Trade Commission's expertise as a competition and consumer protection 
agency, the workshop will examine ways to inform and empower consumers 
to obtain the highest quality and most cost-effective healthcare 
products for their pets.
---------------------------------------------------------------------------

    \1\ American Pet Products Association Industry Statistics & 
Trends.
    \2\ Packaged Facts estimates.
---------------------------------------------------------------------------

    Pet owners spend significantly more money on their pets than in 
past decades, and the market for pet medications has grown 
significantly in recent years.\3\ Manufacturers and veterinarians have 
introduced new and improved diagnostic and therapeutic treatments for 
pets; pet medications have become available at some online and brick-
and-mortar retail outlets; and veterinarians and others have 
increasingly emphasized preventative pet care. In addition, market 
participants note, in recent years it has become easier to administer 
flea and tick control products and heartworm preventatives, and the 
products themselves have become more effective. These products comprise 
the bulk of chronic pet medications sold in the United States. Indeed, 
the sale of prescription and OTC flea, tick, and heartworm products 
totaled nearly $3.7 billion in 2011.\4\
---------------------------------------------------------------------------

    \3\ The size of the overall U.S. pet industry grew steadily from 
$17 billion in 1994 to over $50 billion in 2011. (American Pet 
Products Association Industry Statistics & Trends.) The size of the 
U.S. pet medications market grew from approximately $4.5 billion in 
2006 to approximately $6.7 billion in 2011, and is projected to 
reach $9.25 billion by 2015. (Packaged Facts estimates.)
    \4\ Id. Of the estimated $6.7 billion in U.S. retail sales of 
pet medications in 2011, 36% was for flea and tick control products, 
and 19% was for heartworm preventatives. (Packaged Facts estimates.)
---------------------------------------------------------------------------

Distribution Practices in the Pet Medications Industry

    Historically, veterinarians have been the principal dispensers of 
pet medications because of their unique role in the veterinarian-
client-patient relationship, whereby a veterinarian examines, 
diagnoses, and treats the animal (patient), while also providing 
information to the animal's owner (client). Consumers still purchase 
most of their pet medications from the veterinarians who examine their 
pets, and most pet medication manufacturers choose to distribute their 
products exclusively through the veterinary channel.
    Nonetheless, pet medications are no longer sold exclusively by 
veterinarians. Over the last ten years, brick-and-mortar and online 
retail and pharmacy entities (hereinafter collectively referred to as 
``retailers'') also have begun selling pet medications, especially OTC 
medications. Some evidence suggests that these retailers may offer 
substantial pro-consumer benefits, such as increased convenience and 
lower prices.
    Although retailers may obtain some portion of their pet medication 
products directly from manufacturers or authorized distributors, they 
also rely heavily on secondary supply channels. Most manufacturers 
state that they restrict the distribution of their pet medications to 
the veterinary channel, and that they use well-established tracking 
procedures to ensure the safety and efficacy of their products. Certain 
veterinarians purchase pet medications from manufacturers or authorized 
distributors and then resell some portion of their purchase to 
secondary suppliers for a profit, a practice sometimes referred to as 
``diversion.'' \5\ Some secondary suppliers and retailers claim to have 
protocols in place to verify that the retailers receive bona fide 
products that originated with the manufacturer. Other industry 
participants, however, have questioned whether secondary suppliers and 
retailers always receive bona fide products (as compared to, for 
example, counterfeit product from non-U.S. sources), thereby raising 
potential questions about product safety and authenticity. The workshop 
will examine how competition in sales of pet medications to consumers 
has developed in light of these practices and how prices, product 
supply, and product quality may be affected.
---------------------------------------------------------------------------

    \5\ It should be noted that the term ``diversion'' as used in 
human pharmaceutical markets means the illegal trade in prescription 
narcotics, in which products are not being used by the consumer in 
the manner intended. This is distinct from the situation in the pet 
medications market, in which products obtained through secondary 
supply channels are being used by the consumer in the manner 
intended.
---------------------------------------------------------------------------

    In the workshop, the Commission seeks to examine issues related to 
the distribution of pet medications from practical, economic, and legal 
perspectives. The Commission invites public comment on questions 
relevant to this topic, including:
     How are pet medications distributed to consumers?
     What are the business rationales for various pet 
medication distribution practices?
     How has competition to sell medications to pet owners 
evolved in light of these distribution practices?
     How do these practices affect prices to consumers?
     How do these practices affect product supply and quality?
     How do these practices affect consumer choice?
     How do these practices affect entry into the pet 
medications market?
     How do these practices affect innovation in the pet 
medications market?
     What efficiencies or inefficiencies are associated with 
these practices?
     What, if any, product safety or counterfeiting issues 
exist with respect to these practices? Have there been instances in 
which false or misleading information about product safety risks was 
disseminated to consumers?
     Are there other factors that should be considered when 
analyzing the competition and consumer protection issues related to the 
distribution of pet medications?

Prescription Portability for Pet Medications

    All industry participants agree that pets should be properly 
examined and diagnosed by a veterinarian to determine the most 
appropriate course of treatment for any medical condition, including 
whether any medication should be prescribed. When a veterinarian writes 
a prescription for a medication to be dispensed and subsequently 
administered by a pet's owner, the prescription must be filled with the 
correct medication and dosage and the owner must have access to 
relevant information about the medication and proper administration 
techniques. Some observers argue that veterinarians are in the best 
position to carry out these responsibilities; these observers believe, 
therefore, that veterinarians alone should dispense prescription pet 
medications to their clients. Others argue that licensed pharmacists 
are equally capable of dispensing pet medications to consumers, 
provided the pharmacists dispense the correct medication and dosage as 
prescribed by a veterinarian; these advocates point out that 
veterinarians can still provide relevant information and follow-up care 
to their clients even if they do not dispense the medication. Concerns 
about the safety of pet medications dispensed by pharmacists appear 
less pronounced for OTC medications, which do not require a 
prescription and typically do not require direct supervision by a 
veterinarian.

[[Page 40357]]

    A consumer cannot legally obtain prescription pet medications from 
a retailer without a written, portable prescription from a 
veterinarian. The American Veterinary Medical Association (AVMA) 
advises veterinarians to honor a client's request for a prescription, 
provided that a valid veterinarian-client-patient relationship 
exists.\6\ This guidance is not mandatory, however. State regulations 
vary as to whether veterinarians are legally required to provide 
written prescriptions to clients, and it is unclear to what extent such 
regulatory obligations may be actively enforced against veterinarians. 
It appears that, while many veterinarians provide written prescriptions 
to their clients when requested, some veterinarians have refused to 
provide prescriptions or otherwise have discouraged their clients from 
obtaining pet medications from retailers.
---------------------------------------------------------------------------

    \6\ See Principles of Veterinary Medical Ethics of the AVMA, 
III.C.1.
---------------------------------------------------------------------------

    Federal legislation proposed in House Bill 1406 (``H.R. 1406'' or 
``the Bill'') would require veterinarians to provide clients with 
written prescriptions for all pet medications, regardless of whether 
requested, and to inform clients of their right to have pet medications 
dispensed elsewhere.\7\ The Bill also would prohibit veterinarians from 
charging a fee or requiring waivers of liability for providing written 
prescriptions. H.R. 1406 would require the Federal Trade Commission to 
promulgate rules implementing the statute within 180 days of its 
enactment.
---------------------------------------------------------------------------

    \7\ See Fairness to Pet Owners Act, H.R. 1406, 112th Cong. 
(2011), available at https://www.gpo.gov/fdsys/pkg/BILLS-112hr1406ih/pdf/BILLS-112hr1406ih.pdf.
---------------------------------------------------------------------------

    In the workshop, the Commission seeks to examine issues related to 
the portability of pet medication prescriptions from practical, 
economic, and legal perspectives. The Commission invites public comment 
on questions relevant to this topic, including:
     How varied are current veterinarian practices with respect 
to providing written, portable prescriptions to clients?
     To what extent are consumers aware that they can request a 
portable prescription from their veterinarian and have the prescription 
dispensed elsewhere?
     Which states require prescription portability for pet 
medications? Which do not? Are there states in which a proposal for 
prescription portability for pet medications was rejected by the 
legislature and, if so, why?
     In states that do require prescription portability, what 
recourse do consumers have if a veterinarian refuses to provide a 
written, portable prescription?
     What evidence exists to support a need for federal 
legislation requiring veterinarians to provide written prescriptions to 
their clients?
     What price and non-price benefits can accrue to consumers 
from prescription portability for pet medications?
     What risks or inefficiencies may be posed by prescription 
portability for pet medications?
     Is there a need for federal legislation requiring 
veterinarians to notify clients that they have the right to fill their 
prescriptions at the pharmacy of their choice?
     Is it appropriate to deny veterinarians the ability to 
charge a fee or require a waiver of liability for providing a written 
prescription to clients?
     How might the passage of H.R. 1406 affect price, consumer 
choice, and other forms of competition in the pet medications market?
     How can the prices charged to consumers for pet 
medications by veterinary clinics and retailers best be quantified and 
compared?
     To what extent do retailer prices for pet medications 
affect the prices of medications sold at veterinary practices, or other 
aspects of veterinary clinic operations?
     To what extent would H.R. 1406 affect veterinarians' sales 
of pet medications?
     What compliance costs would veterinarians face if H.R. 
1406 were enacted?
     How might the passage of H.R. 1406 affect pet medication 
distribution practices?
     Should possible amendments to H.R. 1406 be considered?
     Are there other factors that should be considered when 
analyzing the competition and consumer protection issues related to the 
portability of pet medication prescriptions?

Comparison to Fairness to Contact Lens Consumers Act

    Some restricted distribution and prescription portability issues 
existed in the contact lens industry at the time that Congress passed 
the Fairness to Contact Lens Consumers Act (``FCLCA''), Public Law 108-
164. Industry participants have noted both similarities and differences 
between the contact lens industry and the pet medications industry. The 
workshop will examine whether consumer experiences with the FCLCA might 
provide insights about the potential impact of H.R. 1406. The 
Commission invites public comment on questions relevant to this topic, 
including:
     What was the impact of the FCLCA, if any, to consumers?
     What was the impact of the FCLCA, if any, to optometrists 
and ophthalmologists?
     What was the impact of the FCLCA, if any, on entry into 
the contact lens industry?
     What was the impact of the FCLCA, if any, on innovation in 
the contact lens industry?
     What was the impact of the FCLCA, if any, to contact lens 
distribution practices?
     Are there significant similarities or differences between 
the contact lens industry and the pet medications industry, 
particularly with respect to industry distribution practices and issues 
of prescription portability? If so, how should those similarities or 
differences be taken into account in assessing the likely effects of 
H.R. 1406 compared to the FCLCA?
     Are there other factors that should be considered when 
analyzing the competition and consumer protection issues related to the 
FCLCA, and how consumer experiences with the FCLCA might provide 
insights about the potential impact of H.R. 1406?

Instructions for Filing Public Comments

    Interested parties are invited to submit written comments 
electronically or in paper form. We must receive your comment by 
September 14, 2012. Because paper mail addressed to the FTC is subject 
to delay due to heightened security screening, please consider 
submitting your comments in electronic form. Comments filed in 
electronic form should be submitted using the following Web link: 
https://ftcpublic.commentworks.com/ftc/petmedsworkshop (and following 
the instructions on the Web-based form). To ensure that the Commission 
considers an electronic comment, you must file it on the Web-based form 
at the Web link: https://ftcpublic.commentworks.com/ftc/petmedsworkshop. If this notice appears at https://www.regulations.gov/#!home, you may also file an electronic comment through that Web site. 
The Commission will consider all comments that regulations.gov forwards 
to it. You may also visit the FTC Web site at https://www.ftc.gov to 
read the notice and the news release describing it.
    Comments should refer to ``Pet Medications Workshop, Project No. 
P12-1201'' to facilitate the organization of comments. Please note that 
your comment--including your name and your State--will be placed on the 
public

[[Page 40358]]

record of this proceeding, including on the publicly accessible FTC Web 
site, at https://www.ftc.gov/os/publiccomments.shtm. Because comments 
will be made public, they should not include any sensitive personal 
information, such as any individual's Social Security Number; date of 
birth; driver's license number or other State identification number, or 
foreign country equivalent; passport number; financial account number; 
or credit or debit card number. Comments also should not include any 
sensitive health information, such as medical records or other 
individually identifiable health information. In addition, comments 
should not include ``trade secret or any commercial or financial 
information which is obtained from any person and which is privileged 
or confidential'' as provided in Section 6(f) of the Federal Trade 
Commission Act (FTC Act), 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 
CFR 4.10(a)(2). Comments containing material for which confidential 
treatment is requested must be filed in paper form, must be clearly 
labeled ``Confidential,'' and must comply with FTC Rule 4.9(c).\8\
---------------------------------------------------------------------------

    \8\ The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR 
4.9(c).
---------------------------------------------------------------------------

    A comment filed in paper form should include the ``Pet Medications 
Workshop, Project No. P12-1201'' reference both in the text and on the 
envelope, and should be mailed or delivered to the following address: 
Federal Trade Commission, Office of the Secretary, Room H-113 (Annex 
X), 600 Pennsylvania Avenue NW., Washington, DC 20580. The FTC is 
requesting that any comment filed in paper form be sent by courier or 
overnight service, if possible, because U.S. postal mail in the 
Washington area and at the Commission is subject to delay due to 
heightened security precautions. The FTC Act and other laws that the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC Web site, to the extent practicable, 
at https://www.ftc.gov/os/publiccomments.shtm. As a matter of 
discretion, the FTC makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC Web site. More information, including 
routine uses permitted by the Privacy Act, may be found in the FTC's 
privacy policy, at https://www.ftc.gov/ftc/privacy.htm.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2012-16594 Filed 7-6-12; 8:45 am]
BILLING CODE 6750-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.