Our colleague and friend, Stephen H. McNamara passed away on December 28, 2009 of complications from cancer at the age of 66. Steve is survived by Caroline, his wife of 43 years, and his children, Matthew (Veronica) McNamara, and Deborah (Nicholas) Hutchins and six grandchildren. Steve was …
By William T. Koustas – As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is …
By Alan M. Kirschenbaum, Kurt R. Karst & J.P. Ellison – On Thursday morning, the U.S. Senate passed, by a 60-39 vote, H.R. 3590, the Patient Protection and Affordable Care Act. Last weekend, Sen. Harry Reid (D-NV) unveiled a 383-page Manager’s Amendment to the bill. …
By Nisha P. Shah – On December 8, 2009, the Food and Drug Administration ("FDA") issued its final, non-binding guidance for industry on “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” A draft guidance was published in February 2006. The final …
By Carmelina G. Allis – Earlier this month, the United States Court of Appeals for the Second Circuit rendered a summary order affirming the District Court’s judgment for dismissal of the case. We previously reported that FDA had moved to dismiss HiFi DNA Tech, LLC’s (“HiFi’s”) …
By Michelle L. Butler – The Consumer Product Safety Commission (“CPSC” or “Commission”) has now voted to lift the stay of the testing and certification requirements for certain products and extend the stay for others. The Commission issued a press release last Friday regarding the decision, …
By Riëtte van Laack– Earlier this month, a citizen petition was submitted to FDA requesting that the Agency issue an order confirming that prescription prenatal vitamins containing 1-4 mg folic acid, either alone or in combination with other vitamins and minerals, and used to reduce the …
By Kurt R. Karst – A recent decision from the U.S. District Court for the Northern District of Illinois (Eastern Division) presents an interesting solution to a concern about the forfeiture of 180-day exclusivity when a company submits an ANDA containing both a Paragraph IV Certification …
By Michelle L. Butler – On December 16, 2009, the Consumer Product Safety Commission (“CPSC” or “Commission”) posted on its website a draft Federal Register notice that would announce the Commission’s decision to revise the terms of its stay of enforcement of certain testing and …
By Kurt R. Karst – Earlier today, FDA Commissioner Dr. Margaret Hamburg announced in an Agency-wide e-mail that Ralph S. Tyler has been appointed to serve as FDA’s Chief Counsel. Mr. Tyler, who is currently serving as Insurance Commissioner of the State of Maryland, will …
By Cassandra A. Soltis – At the Federal Trade Commission’s ("FTC’s") conference yesterday on food marketing and childhood obesity, officials from the FTC, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the United States Department of Agriculture unveiled tentative proposed …
By Carrie S. Martin – New Jersey’s Attorney General recently endorsed a report prepared by the Division of Consumer Affairs (the “Division”), recommending certain restrictions and obligations on physicians and industry to limit potential conflicts of interest. Many of the recommendations are similar to those …
By Kurt R. Karst – Tick tock! Tick tock! Like sand through the hourglass so too are the days that The Medicines Company (“TMC”) has to convince Congress or the U.S. Patent and Trademark Office (“PTO”) to allow a Patent Term Extension for U.S. Patent …
By Nisha P. Shah & Michelle L. Butler – We recently blogged about an action commenced by Winston Laboratories, Inc. (“Winston”) against FDA, which denied a small business waiver for a new drug application (“NDA”) user fee under the Prescription Drug User Fee Act. See …
By Ricardo Carvajal – FDA has prevailed on summary judgment in a lawsuit brought by BBK Tobacco & Foods, LLP ("BBK") which sought a declaration that separately sold flavored rolling papers are not tobacco products subject to regulation under the FDCA. Previously, FDA issued a draft …
