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

Manufacturers of liquid supplements and energy drinks appear to be in the FDA crosshairs.

On December 3, 2009, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a draft guidance, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” The guidance took many industry insiders by surprise. Because the guidance is still in draft form, CFSAN has invited comments from stakeholders.

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The Food and Drug Administration (FDA) recently launched its Reportable Food Registry (RFR) electronic portal. In conjunction with this launch, FDA has issued a final guidance further discussing the specific requirements.

The RFR requires responsible parties to file a report through the RFR electronic portal at http://rfr.fda.gov when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are deemed by FDA to be “reportable foods.”  A “responsible party” (defined below) must notify FDA of a reportable food within 24 hours of its discovery. These new reporting requirements apply to food and animal feed products.  Infant formula and dietary supplement products are excluded.
 

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Recently, FDA issued its final guidance on the requirements for OTC drugs and dietary supplement labeling to include contact information for consumer reporting of a serious adverse event. This guidance builds upon requirements that were passed into law in the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (“the Act”).
 

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With “effective enforcement” and “transparency” as her resounding themes, the new FDA Commissioner, Margaret A. Hamburg, M.D., on August 6^th, 2009, introduced herself and the FDA’s priorities to the attendees at a conference sponsored by the Food Drug Law Institute. The Commissioner used this opportunity to emphasize her commitment to “swift, aggressive, and effective enforcement of FDA laws and regulations” as well as Agency transparency. 
 

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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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