Antitrust Connection Spring 2009

To: Our Clients and Friends October 30, 2009 Pharmaceuticals, Medical Devices and Biologics Regulatory and Policy Bulletin

Top News

House Reform Bill Lowers Device Tax, But No Exception for Small Companies

The updated House health care reform bill reduces the device industry excise tax to $20 billion (compared to $40 billion in the Senate bill), but includes no exceptions for small companies.

Senators Introduce Bill to Eliminate Write-Off for Drug Marketing Costs

Senators Al Franken (D-Minn.), Sherrod Brown (D-Ohio), and Sheldon Whitehouse (D- R.I.), have introduced S.1763, a bill that would eliminate the tax write-off for prescription drug marketing costs, as a means to "restore lost revenue" to the federal government. The bill covers direct-to-consumer advertising in any media and "any activity designed to promote the use of a prescription pharmaceutical directed to providers or others who may make decisions about the use of prescription pharmaceuticals (including the provision of product samples, free trials and starter kits)."

U.S.-Japan Pilot Project In Pre-Market Collaboration to Begin Soon

The FDA and its Japanese counterpart will soon name the two devices that they will use as part of a pilot project in which the countries’ agencies will collaborate on clinical trial protocol development and pre-market review of medical devices. The pilot is part of the of the Harmonization by Doing (HBD) initiative.

Pfizer, GSK and Bayer accept Ecuador’s plan to break patents

Pfizer, GlaxoSmithKline (GSK) and Bayer have expressed their support for the government of Ecuador’s decision to sidestep patents on more than 2,000 drugs, enabling the country to produce them locally or import them as “generics.” The move is similar to that seen in countries including Brazil and Thailand, who have taken similar action in an effort to reduce drug prices.

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A Nation Battling Flu, and Short on Supplies Articles in the New York Times and the Washington Post discuss the causes and effects of the government’s overestimation of the amount of flu vaccine that would be available to the public this month. The Washington Post is also reporting on the shortage of Tamiflu, a recommended treatment for swine flu.

In addition, the FDA has announced that it will combat the marketing of unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus, and has launched a website that lists such fraudulent products.

WHO to Weigh in On Swine Flu Vaccine Dosage The WHO is set to give its recommendation on whether one or two doses of the swine flu vaccine are needed to combat the disease.

DEA crackdown hurts nursing home residents who need pain drugs Senators Herb Kohl (D-Wis.) and Sheldon Whitehouse (D-R.I.), along with a coalition of pharmacists and geriatric experts, have stated that tougher enforcement of the Controlled Substances Act is denying hospice and elderly patients needed pain medication, according to an article in the Washington Post.

Stem Cell Research in the States Supporters of embryonic stem cell research are worried that legislation debated in a Michigan state Senate committee could threaten the progress of research in the state, according to an article in the Chicago Tribune.

In California, the California Institute for Regenerative Medicine has awarded $230 million in grants to 14 stem cell research projects.

Wisconsin Proposal Would Allow Sales of Drugs Below Cost A proposal has passed the Wisconsin Assembly that would exempt prescription drugs from the state’s “minimum-markup” law and allow pharmacies to sell them below cost.

Confidential Data in NCAR Restricted to Full Participants, GHTF Says The Global Harmonization Task Force (GHTF) has indicated that it is taking steps to safeguard confidential information in device adverse event reports and postmarket surveillance and has stated that only full participants in its National Competent Authority Report (NCAR) exchange program will be given access to confidential or highly sensitive information contained in the reports.

Study Finds Clinicians Favor Bending Clinical Trial Rules An article in the New York Times discusses the findings of a recent study in which investigators found that 90 percent of clinicians in clinical trials believed that ignoring certain entry criteria was acceptable if a patient could, in their estimation, benefit from the trial. In addition, more than half of clinicians surveyed indicated that they thought that researchers should deviate from study rules if doing so might improve a patient’s care.

EFPIA Launches Pilot to Combat Counterfeiting The European Federation of Pharmaceutical and Industries Association (EFPIA) is launching a pilot that will apply 2D barcode labelling to 110,000 drug products in 25 pharmacies in Sweden, in an effort to reduce counterfeiting.

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Alpha acquires CRO to target Mass bio Environmental laboratory Alpha Analytical has acquired CRO Boston Analytical and is now targeting the Massachusetts, US biotech sector, according to its president Mark Woelfel.

Novotech Opens Management Hub in Malaysia Contract research organisation Novotech has opened a new “management hub” in Kuala Lumpur, Malaysia, in what the CRO says will serve as a base for expansion in the booming Asia-Pacific contract research sector.

Japan’s Astellas to Pay Up to $765M for Prostate Cancer Drug Rights Astellas Pharma Inc., Japan’s second-largest drugmaker, has agreed to pay $110 million up front and as much as $655 million in future payments to Medivation Inc. for global rights to develop and sell an experimental medicine for prostate cancer.

Novartis Prepares For Diovan Patent Expiries Novartis has stated that it is shifting marketing efforts away from its drug Diovan and focusing on drugs such as Tekturna or Exforge in an effort to forestall generic competition that will begin to surface in two years.

Judge Dismisses Medtronic Product Liability Claims A Minnesota district judge has dismissed 600 lawsuits filed by patients who claimed they were harmed by a faulty heart defibrillator lead made by Medtronic Inc.

Allergan Wins Continued Product Protection for Alphagan Allergan, Inc. has won continued product protection after a judge ruled that generic drugmakers Apotex Inc and Exela PharmSci infringed patents for its Alphagan glaucoma treatment.

Sanofi-Aventis Alleges Patent Infringement Sanofi-Aventis has alleged that competitors Hospira Inc. and Apotex Inc. have infringed its patents for cancer drug Taxotere.

Appeals Court Rules Bayer Patent Invalid The U.S. Court of Appeals for the Federal Circuit in Washington has ruled that Bayer AG’s patent on birth-control pill Yasmin is invalid.

Jury Finds Pfizer Liable for $3.7 M damages for concealing breast cancer risks A Philadelphia jury has concluded that Pfizer is liable for $3.7 million in damages for concealing the risks of developing breast cancer from its hormone-replacement therapy drug Prempro.

Johnson & Johnson Whistle-Blowing Trial Begins The trial has begun in the case of a former Johnson & Johnson employee who claims she was wrongfully terminated after blowing the whistle on the company’s off-label promotion of its drug Risperdal. Thus far, a sales representative from the company has testified that he encouraged doctors to prescribe the drug for unapproved uses.

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ISO to Develop Tighter Standards for Glucose Monitors by 2012 The International Organization for Standardization’s (ISO) clinical laboratory testing and in vitro diagnostic test systems technical committee has announced that it has launched an initiative to tighten accuracy standards for glucose monitoring devices, which it expects to complete in three years.

FDA Completes UDI Pilot, But Anxieties Over Data Requirements Remain Participants in a six-week pilot program aimed at assessing the feasibility of collecting and storing unique device identification data have shared concerns about the volume and type of information that would be required under the program.

Medco to Undertake Cost Effectiveness Study

Medco has announced that it will undertake a "Genotype-Guided Comparison of Clopidogrel and Prasugrel Outcomes Study" to generate cost effectiveness data comparing Bristol-Myers Squibb's Plavix with the recently launched Effient. The study is part of the firm’s "Genetics for Generics" project.

FDA Gives Vyvanse Five Years Exclusivity Shire PLC has announced that the FDA has reaffirmed its prior decision and will give its drug Vyvanse five years of market exclusivity.

FDA Panel Backs First Non-Drug Asthma Treatment An FDA panel of respiratory device experts has voted in favor of approving Asthmatx's Alair System for use under certain conditions, including long-term safety monitoring of patients, according to an article in the New York Times.

FDA Authorizes Emergency Use of Intravenous Antiviral Peramivir for 2009 H1N1 Influenza for Certain Patients, Settings The FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors associated with peramivir to FDA’s MedWatch program within 7 calendar days from the onset of the adverse event.

FDA Approves New Treatment for Chronic Lymphocytic Leukemia The FDA has approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia.

FDA Questions Human Genome Drug The FDA has stated that Human Genome Sciences’ experimental anthrax treatment may not be more effective than older therapies, according to articles in the Washington Post and Bloomberg.

FDA Holds Up Transcept Drug Due to Side Effects The FDA has issued a "complete response" letter for the Transcept Pharmaceuticals' application for its drug Intermezzo, which would be the first insomnia drug to treat middle-of-the-night awakenings, over the possibility of residual side effects.

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Amgen to Use SRE Data to Attempt to Escape New Trial Requirement Amgen will attempt to use data from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve the FDA's questions about the drug's effects in cancer patients, that the agency raised in its "complete response" letter on d- mab's use in treating patients with bone loss due to hormone ablation therapy.

Repros, NIH amend license for suspended drug Proellex Repros Therapeutics and NIH have agreed to amend Repros’ license for Proellex in order to give the company more time to resolve issues that prompted the FDA to put the uterine fibroid drug on clinical hold.

AstraZeneca Pulls Approval Applications for Cancer Drug Zactima AstraZeneca has withdrawn its regulatory submissions for its cancer treatment Zactima after an updated analysis showed adding the drug to chemotherapy resulted in no overall survival advantage.

Genentech and FDA notify healthcare professionals about Rituxan and PML Genentech and FDA are notifying healthcare professionals about a third case of progressive multifocal leukoencephalopathy [PML], the first case of PML in a patient with rheumatoid arthritis [RA] treated with Rituxan who has not previously received treatment with a TNF antagonist. Information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.

Recall of Accusure Insulin Syringes Qualitest Pharmaceuticals and the FDA have notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall.

FDA Issues Warning Letters The FDA has issued a warning letter to King Pharmaceuticals for its EMBEDA Extended Release Capsules. It has also issued a warning letter to Sanofi Aventis for its UROXATRAL® (alfuzosin HCl) Extended-Release Tablets.

Stryker Unit, Ex-Chief, Indicted for Misleading FDA A grand jury has indicted a Stryker Corp. unit that makes bone-surgery products and its former president for misleading the U.S. Food & Drug Administration about the uses of its products.

FDA Updates Listing of Resolved Drug Shortages The FDA has updated its listing of Resolved Drug Shortages to include Oxycodone Immediate Release Tablets, Dexrazoxane for Injection, and Zinecard.

CMS Announces Reversal of Avastin Reimbursement Policy The Centers for Medicare and Medicaid Services has announced that it will reverse its decision to cut reimbursement for Avastin. The earlier payment decision had the effect of forcing doctors to use a more expensive drug.

GAO Publishes Reports on Oversight of Clinical Investigators, New Drug Approval The GAO has released two new reports – one entitled “Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators” and another entitled ”FDA Needs to

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Enhance Its Oversight of Drugs Approved on the Basis of Surrogate Endpoints.” An article in the New York Times discusses the implications of GAO’s report on new drug approval.

CBO Issues Report on Pharmaceutical R&D CBO has issued a report entitled “Pharmaceutical R&D and the Evolving Market for Prescription Drugs.”

HHS Issues Report on Adverse Event Reporting for Medical Devices The HHS Office of Inspector General has published a report entitled “Adverse Event Reporting for Medical Devices.”

Regulatory Notices

FDA Publishes Guidance on Protecting the Rights, Safety, and Welfare of Study Subjects The FDA has announced that it has published a guidance for industry entitled “Investigator Responsibilities--Protecting the Rights, Safety, and Welfare of Study Subjects.” Comments on the guidance may be submitted at any time. More information is available at http://edocket.access.gpo.gov/2009/E9-25629.htm.

FDA Publishes Guidance on Structured Product Labeling Standard The FDA has published a draft revised guidance for industry and reviewers entitled “SPL Standard for Content of Labeling Technical Qs & As.'' The guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) in extensible markup language (XML). While the FDA will accept comments on the guidance at any time, comments must be submitted by December 28, 2009, to be considered before the FDA begins drafting its final version of the guidance. More information is available at http://edocket.access.gpo.gov/2009/E9- 25940.htm.

FDA Issues Corrections to 2010 Fee Rates for Prescription Drug User Fee Act The FDA has issued a notice to correct its August 3, 2009, Federal Register Notice (74 FR 38451) announcing the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. More information is available at http://edocket.access.gpo.gov/2009/E9-25804.htm.

FDA Withdraws Notice of Eligibility Permitting Consideration of S. boulardii for Addition to the Monograph for OTC Antidiarrheal Drug Products The FDA has published a notice that it has determined that Saccharomyces boulardii is more appropriately regulated as a biological product under the biologics license application system than as an OTC drug product under the monograph system, and is withdrawing its notice of eligibility permitting consideration of S. boulardii for addition to the monograph for OTC antidiarrheal drug products. More information is available at http://edocket.access.gpo.gov/2009/E9-25803.htm.

FDA Amends IND Application Regulations The FDA has issued a notice that it is amending its investigational new drug application regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. More information is available at http://edocket.access.gpo.gov/2009/E9-26095.htm.

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Public Meetings

FDA Announces Meeting of Anti-Infective Drugs Advisory Committee The FDA has announced that the Anti-Infective Drugs Advisory Committee will meet on December 9, 2009, from 8 a.m. to 5 p.m. and on December 10, 2009, from 8 a.m. to 4:30 p.m. in Gaithersburg, Maryland. The Committee is expected to review inhalable aztreonam lysine, Gilead Sciences Inc.’s investigational antibiotic for cystic fibrosis patients with deadly infections. More information is available at http://edocket.access.gpo.gov/2009/E9-25628.htm and http://edocket.access.gpo.gov/2009/E9-25627.htm.

FDA Announces Meeting of Endocrinologic and Metabolic Drugs Advisory Committee The FDA has announced that the Endocrinologic and Metabolic Drugs Advisory Committee will meet on December 15, 2009, from 8 a.m. to 5 p.m., in Gaithersburg, Maryland. More information is available at http://edocket.access.gpo.gov/2009/E9-25805.htm.

FDA Announces Meeting of Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee The FDA has announced that the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet on December 15, 2009, from 8 a.m. to 5 p.m. in Gaithersburg, Maryland. More information is available at http://edocket.access.gpo.gov/2009/E9-25806.htm.

FDA Announces Public Workshop on Transmission of Arboviruses The FDA has announced that it will be hosting a public workshop entitled “Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ Safety.” The purpose of the workshop is to assess the risk and discuss approaches to minimize the incidence of transmission of arboviruses (arthropod-borne viruses), by transfusion, infusion, implantation, or transplantation in the United States. The workshop will be held on December 14, 2009, from 8:30 a.m. to 5:30 p.m. and December 15, 2009, from 8:30 a.m. to 5:30 p.m. in Bethesda, Maryland. More information is available at http://edocket.access.gpo.gov/2009/E9-25802.htm.

FDA Announces SAB Meeting The FDA has announced that the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR) will meet on November 17, 2009, from 8:15 a.m. to 5 p.m. and on November 18, 2009, from 8:15 a.m. to 2 p.m. in Jefferson, AR. At least one portion of the meeting will be closed to the public. More information is available at http://edocket.access.gpo.gov/2009/E9-25941.htm.

More Information If you have any questions regarding any of these issues, please contact:

Mark Mansour Partner [email protected] 1 202 508 6019 Washington

Alan K. Parver Partner [email protected] 1 202 508 6332 Washington

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Steven Kent Stranne Partner [email protected] 1 202 508 6349 Washington

Megan A. Gajewski Associate [email protected] 1 202 508 6302 Washington

Patrice M. Hayden Associate [email protected] 1 202 508 6147 Washington

Emily K. Strunk Associate [email protected] 1 202 508 6360 Washington

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