On May 2, 2007, FDA announced the availability of a report, titled “Critical Path Opportunities For Generic Drugs.” The report identifies several unanswered scientific questions that FDA believes impede the development of generic versions of commonly used brand name drugs, and is part of FDA’s …
As we previously reported, FDA has promised to accelerate its enforcement efforts against marketed unapproved drugs in 2007. Indeed, in the past month, FDA has announced two enforcement actions, and future actions are likely. In early April 2007, FDA announced that companies must stop manufacturing and …
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & Hartson. Mr. Shapiro’s practice focuses primarily on assisting medical device and …
On April 20, 2007, Arnold & Porter submitted a citizen petition and a petition for stay of action on behalf of Medicis Pharmaceutical Corp. asking FDA to change the Agency’s policy with respect to Hatch-Waxman patent and exclusivity benefits for combination drugs containing a so-called …
On April 20, 2007, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) issued a Warning Letter to Alcon Laboratories, Inc. concerning the company’s promotion of CIPRODEX (ciprofloxacin, 0.3%; dexamethasone, 0.1%) Sterile Otic Suspension in a retail sell sheet and a sales aid. FDA approved …
On April 13, 2007, the U.S. Court of Appeals for the District of Columbia ruled in Moms Against Mercury v. FDA that the court lacks subject matter jurisdiction to decide whether FDA should classify “pre-amendment” Encapsulated Amalgam Alloy and Dental Mercury (“EAADM”) devices. The Petitioners, …
On April 16, 2007, Cell Therapeutics, Inc. (“CTI”) agreed to pay $10.5 million to resolve allegations of the company’s illegal marketing of TRISENOX (arsenic trioxide), a prescription drug indicated for treatment of refractory or relapsed acute promyelocytic leukemia. The case arose out of a complaint …
On April 18, 2007, Analysis Group, Inc. announced the release of a report assessing the effects of the market entry of authorized generics on paragraph IV patent certifications. FDA has described an authorized generic as “[a]ny marketing by an NDA holder or authorized by an …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Carrie S. Martin has joined the firm as an associate. Ms. Martin earned a law degree with honors from The George Washington University Law School in 2004. She served as an Articles Editor for the …
Earlier today, FDA issued its decision with respect to amlodipine generics and the applicability of Mylan’s 180-day exclusivity and Pfizer’s pediatric exclusivity. The U.S. District Court for the District of Columbia in Mylan v. Leavitt had ordered FDA to respond to Mylan’s TRO motion by …
On April 12, 2007, the Association of American Physicians & Surgeons (“AAPS”), Concerned Women for America, Family Research Council, and Safe Drugs For Women filed a complaint in the U.S. District Court for the District of Columbia against FDA seeking declaratory and injunctive relief concerning …
On April 4, 2007, FDA published proposed regulations for the labeling of irradiated foods and dietary supplements. The proposed revisions are in response to the Farm Security and Rural Investment Act of 2002, which directed FDA to propose changes to the current regulations at 21 …
On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy. The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, …
The Government Accountability Office (“GAO”) recently released a report detailing the revenue information from certain companies that participate in the Medical Device User Fee Program (“MDUFMA”). MDUFMA authorizes FDA to charge user fees to review applications for the clearance or approval of medical devices. MDUFMA …
Last week, we reported on several citizen petitions submitted to FDA by Mylan and Pfizer concerning the availability and applicability of 180-day exclusivity and pediatric exclusivity to amlodipine drug products. FDA has also established a separate docket to solicit the views of interested parties on …
