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 …
By Susan J. Matthees & A. Wes Siegner – Last week FDA published a new guidance document titled “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods.” The guidance document includes a …
By Kurt R. Karst – Although much discussion has been devoted over the past few days to Sen. Byron Dorgan’s (D-ND) proposed amendment (SA 2793) to the Senate Health Care Reform Bill that would let U.S. pharmacies and drug wholesalers import FDA-approved drugs from certain …
By Jamie K. Wolszon – The U.S. Government Accountability Office (“GAO”) released a report earlier this week finding that FDA’s postmarket drug safety decision-making and oversight, while improved since a prior investigation a few years ago, continues to have gaps. The GAO recommended that FDA …
By Kurt R. Karst – A recent decision from the Patent and Trademark Office (“PTO”) in which the Office granted an interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,407,914 but denied interim extensions for U.S. Patent Nos. 5,260,273 and 5,789,381 covering the drug product …
By Ricardo Carvajal – When FDA sent letters to manufacturers of caffeinated alcoholic beverages asking them to furnish evidence supporting a conclusion that the use of caffeine in an alcoholic beverage is generally recognized as safe (GRAS) or prior sanctioned, the agency allowed 30 days …
By Alan Kirschenbaum − We previously reported on a March 2009 Department of Defense (DoD) regulation establishing a prescription drug “refund” program to implement section 703 of the National Defense Authorization Act of 2008 (NDAA 08). That section provides that prescriptions filled on or after January …
By William T. Koustas – We previously reported that the United States District Court for the District of Columbia ruled in favor of the American Bar Association and prevented the Federal Trade Commission ("FTC") from enforcing its Red Flags Rule (“the Rule”) on attorneys. On …
By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s). FDCA section 911(a) prohibits the introduction of an MRTP into interstate commerce unless FDA has issued …
By Carrie S. Martin – On November 19, the Washington Legal Foundation (“WLF”), along with three other organizations, filed an amicus curiae brief in support of Allergan, Inc.’s First Amendment challenge to FDA’s ban on “truthful, accurate and nonmisleading speech” proactively disseminated to health care …
