By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).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 – …
By A. Wes Siegner, Jr. and Ricardo Carvajal Sen. Kerry has introduced the Medical Foods Equity Act of 2009 with the goal of securing insurance coverage for certain medical foods. The legislation would secure coverage under federal insurance plans (e.g., Medicaid and Medicare), plans governed by the …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation. Mr. …
By David B. Clissold and Ricardo Carvajal The Center for Tobacco Products has scheduled a web-based training session on use of the eSubmitter program to electronically submit establishment registration and product listing information (see here). Submission of that information by December 31 is required under …
By Jeffrey N. Wasserstein Your faithful bloggers at FDA Law Blog are, as you might expect, big fans of social media tools. After all, we blog, we tweet, and we are on LinkedIn, and Facebook (but no, we’re not friending all of our readers). (We also …
By Kurt R. Karst – Buried in the Conference Report (Report No. 111-279) accompanying the recently-enacted Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) is a request that FDA examine and report on “A” rated …
