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By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).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 …
Thanks to our faithful readers, we made the list for the Third Annual ABA Journal Blawg 100. One of our readers, an FDA official, said that “there is no one within the agency that does what this blog provides.” We are humbled by this honor and hope …
By Jeffrey N. Wasserstein – We missed this interesting decision in the run-up to Thanksgiving. Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest. We previously blogged on the Cell Therapeutics Inc. (“CTI”) case. To sum up …
By Kurt R. Karst – Returning from the Thanksgiving Holiday, we found our inbox chock-full of recent preemption decisions of note involving generic drugs. First off is a decision from the U.S. Court of Appeals for the Eighth Circuit in Mensing v. Wyeth. That case …
By J.P. Ellison – Earlier this month a federal district court in Georgia granted summary judgment in a Lanham Act suit that raised a number of FDA issues. The plaintiff in the suit manufactured two prescription acne products under the trade name Benziq. Defendant manufactured two …
By Riëtte van Laack – In two little noticed speeches delivered at the Council for Responsible Nutrition’s ("CRN’s") Annual Symposium on October 22, 2009, FTC’s Director David Vladeck and FDA’s Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. …
By Alan M. Kirschenbaum – Yesterday, the Senate voted 60 to 40 to send its 2,074-page health care reform bill, the “Patient Protection and Affordable Care Act,” to the floor for debate. The bill represents a merger of two bills reported by the Senate Finance Committee …
By Kurt R. Karst – In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval on an ANDA referencing the old …
By Dara Katcher Levy On November 12 and 13, FDA held a Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools. The hearing represents FDA’s second attempt at gathering information on using the internet to promote medical products – …
