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”).
 Continue Reading OTC Drug and Dietary Supplement Labeling: Adverse Event Reporting Information

With “effective enforcement” and “transparency” as her resounding themes, the new FDA Commissioner, Margaret A. Hamburg, M.D., on August 6th, 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. 
 Continue Reading Hamburg at the Helm: FDA Commissioner Sets New Enforcement Priorities

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.
Continue Reading Vermont Data Mining Law Under Review By 2nd Circuit Appeals Court

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.Continue Reading Reverse Payment Issue Continues to Sizzle

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.
 Continue Reading Restaurants, Too?

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. 
 Continue Reading EU Cosmetics Regulation Receives Welcome Facelift