By Alan M. Kirschenbaum – Late last year, we reported on a decision of the D.C. District Court upholding the Department of Defense’s ("DOD’s") authority to apply Federal Ceiling Price ("FCP") limitations to all prescriptions filled on or after January 28, 2008 under the TRICARE …
By Kurt R. Karst – Two recent rulings out of the U.S. District Court for the Eastern District of Pennsylvania stemming from allegations about antitrust violations from the submission of citizen petitions have once again raised the issue of so-called “sham” citizen petitions and, insofar …
Hyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-chief blogger at fdalawblog.net and self-described social media guru) will be speaking on the regulation of social media at the American Conference Institute’s 8th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry, taking place in …
By Kurt R. Karst – FDA’s ability to force a prescription-to-over-the-counter switch (“Rx-to-OTC switch”) has been hotly contested over the past decade. The crux of the debate concerning forced Rx-to-OTC switches is whether FDA, absent a New Drug Application (“NDA”) sponsor’s consent, has the authority …
By Michelle L. Butler – This week, the parties in the Winston Laboratories case filed a Stipulation of Dismissal with Prejudice Pursuant to Fed. R. Civ. P. 41(a). This case involved FDA’s interpretation of the term “affiliate” in its decision to deny Winston a small …
By Kurt R. Karst – Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (“Graceway”) requesting that the Agency refuse to approve Abbreviated New Drug Applications (“ANDAs”) for generic versions of Graceway’s ALDARA (imiquimod) Cream, 5%, unless such applications contain, among …
By Kurt R. Karst & Frank J. Sasinowski – We recently reported on the banner year FDA’s Office of Orphan Products Development (“OOPD”) had in 2009, surpassing the 2,000 orphan drug designation mark and designating a near-record 160 products for orphan (i.e., rare) diseases and …
By Kurt R. Karst – As we predicted, Massachusetts-based The Medicines Company (“TMC”) has sued the U.S. Patent and Trademark Office (“PTO”) and FDA in connection with the company’s efforts to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) …
For heavily-regulated companies, such as those regulated by the Food and Drug Administration, it is common for companies to seek advice from in-house and outside counsel regarding whether proposed conduct would violate the law. It has become increasingly popular for federal prosecutors to target the …
By Kurt R. Karst – Is an ANDA applicant who cites a 505(b)(2) drug as the Reference Listed Drug (“RLD”) required to certify to Orange Book-listed patents covering the 505(b)(2) RLD drug as well as to Orange Book-listed patents covering the original listed drug approved …
By Ricardo Carvajal & Diane B. McColl – In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to …
By Kurt R. Karst – Now that we are a little more than six years after the December 8, 2003 enactment of Title XI of the Medicare Modernization Act (“MMA”), which, among other things, amended the FDC Act to create a new 180-day exclusivity regime …
Hyman, Phelps & McNamara, P.C.’s Josephine Torrente will be co-chairing and speaking at ACI’s upcoming two-day Risk Evaluation and Mitigation Strategies Conference. Ms. Torrente will be presenting on post-marketing safety requirements and applicants’ obligations under FDAAA. The conference is scheduled for April 19-20 at the …
By James R. Phelps – By a series of treaties, the nations of the world have given the United Nations (“UN”) a significant role in the development of systems of regulation of substances, including vitally needed medicines, that might be abused. The World Health Organization …
By Ricardo Carvajal – According to a press release issued by Senator Mark Pryor's office, Senator Pryor (D-AR) has teamed up with Senator Benjamin Cardin (D-MD) to introduce the Nanotechnology Safety Act of 2010. The bill, introduced on January 21, 2010 as S. 2942, is …
