The ability to successfully obtain FDA approval is critical to the success of a medical device. However, sometimes even the most dedicated of efforts fall flat when FDA says “No.” What then? What can you do if FDA says it believes there is not an …
By Kurt R. Karst – Like Yogi Bear, who is always on the lookout for a better way to procure pic-i-nic baskets, we are always on the lookout for innovative strategies companies come up with to protect their market exclusivity. Two strategies have recently come by …
By Peter M. Jaensch & Alan M. Kirschenbaum – The Office of the Inspector General (“OIG”) of the Department of Health and Human Services has issued a favorable Advisory Opinion on a manufacturer-sponsored patient reminder program for a vaccine, concluding that OIG will not seek penalties under …
By Riëtte van Laack – Recent FDA enforcement actions suggest that FDA will diligently pursue companies that have received Warning Letters for certain violations – and that have allegedly failed to clean up their act. U.S. Marshals recently seized product from UAS Laboratories (“UAS”), a probiotics dietary …
By Kurt R. Karst – Earlier this week, FDA announced the availability of a final guidance document, titled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act,” explaining the Agency’s interpretation of this statutory provision …
By Peter M. Jaensch – In what a federal grand jury charges was a several-months-long effort in 2010 to maintain their job security, a clinical trial investigator and clinical trial coordinator in Kansas allegedly falsified clinical drug trial study data in submissions to the Food and …
By Susan J. Matthees – The DOJ has announced that a New Jersey jury found two dietary supplement companies and their owner and managers guilty of criminal contempt for allegedly violating a Consent Decree that had enjoined them from engaging in certain conduct. In 2009, the government …
The Food and Drug Law Institute (“FDLI”) will host an intensive one-day, must-attend conference on June 24, 2011, at the Westin City Center in Washington, DC, titled “Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy.” The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, …
By Nisha P. Shah & Kurt R. Karst – The U.S. Government Accountability Office (“GAO”) recently issued a report required by the FDA Amendments Act of 2007 (“FDAAA”) concerning the effects of the Pediatric Research Equity Act (“PREA”) (FDC Act § 505B) and the Best Pharmaceuticals …
By Carmelina G. Allis – The “Menaflex” is a collagen meniscus implant intended to reinforce damaged meniscal soft tissue. ReGen Biologics, Inc. obtained 510(k) clearance for the Menaflex in 2008 as a Class II device. On March 30, 2011, FDA rescinded this clearance. Last week, ReGen …
By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA has issued a draft guidance that would limit the sale and distribution of “Research Use Only” (RUO) and “Investigational Use Only” (IUO) products. (A copy of the Federal Register notice announcing the guidance is available here.) …
By Kurt R. Karst – Last week, in a seven-page response, FDA denied an October 18, 2010 Citizen Petition submitted on behalf of Lupin Limited (“Lupin”) requesting that FDA determine that Teva Pharmaceuticals USA, Inc.’s (“Teva’s”) ANDA No. 79-081 for a generic version of COMBIVIR (lamivudine …
By Ricardo Carvajal – FDA issued a letter of enforcement discretion for the use of certain qualified health claims on the labeling of an infant formula marketed by Nestle Nutrition (Gerber). The claims provided in FDA's letter are: Very little scientific evidence suggests that, for healthy infants …
By Jamie K. Wolszon – Trade reports recently indicated that FDA intended to issue by the end of May a draft guidance outlining its policy for “Research Use Only” (“RUO”) and “Investigational Use Only” (“IUO”) products such as reagents and instruments. Last week FDA posted on …
By Kurt R. Karst – Last Friday, Nostrum Pharmaceuticals, LLC (“Nostrum”) lodged a Complaint against FDA in the U.S. District Court for the District of New Jersey seeking declaratory and injunctive relief arising from the Agency’s decisions on pre-Medicare Modernization Act (“MMA”) 180-day exclusivity with respect …
