FDA Law Update : FDA Regulation Lawyer & Attorney : Sheppard Mullin Law Firm : Food & Drug Administration Product Regulations

We reported recently that Vermont’s data mining law (i.e. Vermont’s Prescription Confidentiality Law), which is to take effect on July 1, was upheld by the U.S. District Court for the District of Vermont. The law will ban all use of prescriber data for marketing purposes unless a physician explicitly agrees to a waiver. On June 23, 2009, the 2nd Circuit was petitioned to prevent enactment of the law in an appeal from a district court holding that although prescriber data is protected speech under the First Amendment, the law itself is not unconstitutional because it satisfies the three-prong test used by courts to analyze statutory limitations of commercial speech.
 

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We reported recently that the issue of reverse settlement payments to generic drug manufacturers was continuing to heat up this summer.  FTC Chairman Jon Leibowitz’s recent comments on the issue further support this forecast. In a speech before the Center for American Progress, Leibowitz stated that the FTC "has made stopping these deals a top priority," and he urged Congress to do the same.

Reverse settlement payments occur after a brand-name drug manufacturer sues a generic manufacturer for patent infringement. In settling the case, the companies enter a "pay-for-delay" agreement, whereby the generic accepts a payment to stay out of the marketplace for a certain period of time.
 

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On June 12, 2009, Congress passed a legislation empowering the Food and Drug Administration to regulate cigarettes and tobacco products. Just one day after the Senate approved the bill, the House decided to forgo its own version of the bill and passed the Senate bill with a final vote of 307-97. President Obama stated he will promptly sign the bill into law. Enactment of such legislation will end a long battle over the years to give FDA the authority to regulate the manufacturing, marketing and sale of cigarettes and other tobacco products. The bill, authorizes sweeping regulation of the tobacco industry.
 

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As the Senate works toward health-care reform legislation, the Senate HELP Committee has released the 615 page bill that Senator Chris Dodd (D-Conn.) will soon introduce on behalf of Senator Edward Kennedy (D-MA), The Affordable Health Choices Act. The Senate’s HELP and Judiciary committees expect to begin the markup process this month.

Included with a plan to cover millions of uninsured, the bill aims to lower health-care spending by mandating various preventive measures.  One of these: A requirement to disclose nutrition facts for menu items served in America's chain restaurants.
 

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The issue of a patent litigation settlement in the form of payments by a brand name drug company to the defendant to delay marketing a generic version of its brand name counterpart is heating up this summer. Indeed, it is currently both before the Supreme Court and Congress.

A group of indirect purchasers filed a petition with the Supreme Court seeking review of the Federal Circuit’s decision in In Re:Ciprofloxacin finding that Bayer’s $398 million payment to Barr and Hoechst Marion Roussel (now Sanofi-Aventis) to delay marketing a generic version of a drug did not violate federal antitrust laws. Arkansas Carpenters Health and Welfare Fund is asking the court to determine whether reverse payments to settle patent litigation are per se lawful without regard to the amount paid or strength of the underlying patent challenge. This is the third time the issue of reverse payments has been brought to the Supreme Court. The Court refused to hear the prior two cases.
 

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Pharmaceutical companies may face increasing hurdles in marketing their products to physicians as states begin to ban prescription data mining. To date, legal challenges to such state laws have largely failed. Prescription data mining is an important marketing tool for pharmaceutical companies.
 

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Pharmaceutical Research and Manufacturing of America (“PhRMA”) has revised its Principles on Clinical Trials to further reflect its commitment to transparency in clinical trials and build upon FDAAA requirements. PhRMA's updated principles trial address four key issues: protecting research participants; conduct of clinical trials; ensuring research objectivity; and providing clinical trial information. The PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results take effect on October 1, 2009.
 

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Last month, the European Parliament approved new rules that will increase cosmetic safety and simplify regulatory procedures in the European Union. The legislation, which resulted from a compromise negotiation between Parliament and Council representatives, will take the form of a single regulation that applies to all member states simultaneously, and will replace the patchwork of 27 sets of national rules and 55 amendments that comprise the EU Cosmetic Directive of 1976. 
 

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Clinical trials are the lifeblood of biotech. Finding the right service providers (CROs, safety, IVRS, consultants, contract manufacturers and many others), as well as the right clinical investigators and sites, results in a complex web of legal obligations and potential liabilities. Limitation of liability clauses can reduce a party's exposure if a contractual obligation is breached. More often, limitations of liability provisions are used to shift risk to the sponsor of the clinical trial. But, if your contracts are well negotiated and drafted, the risks can be carefully and fairly allocated between the parties in a balanced and reasonable manner. Because of the complexity of the legal relationships and liabilities found in clinical trials, this article is limited to a brief description of limitation of liability clauses, and their general strengths and weaknesses.
 

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