By Michelle L. Butler & Alan M. Kirschenbaum – On August 3, CMS issued final versions of three agreements to implement the Medicare Coverage Gap Discount Program. We previously described the guidance CMS developed with regard to this program as well as the draft agreements …
By Kurt R. Karst – For years now, folks (of the Hatch-Waxman type) have clamored for a full list of 180-day exclusivity decisions. FDA has not put together such a list, so we decided to try and put together our own list – the …
By Carrie S. Martin – On July 28, a district court in the State of Washington granted a motion for summary judgment in favor of Plaintiff which sought coverage of Medicare claims for a medical device. International Rehabilitative Sciences, Inc. v. Sebelius, No. C08-5442-RBL (W.D. …
By Carmelina G. Allis – Since September 2009, the Center for Devices and Radiological Health (“CDRH”) has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. This week, the 510(k) Working Group and the Task …
By Dara Katcher Levy - In what we believe is DDMAC’s first foray into tackling one of the “gray-areas” created by social media, on July 29, DDMAC issued an Untitled Letter to Novartis Pharmaceuticals for Rx drug content “grabbed” by a Facebook Share widget. For those that …
By Kurt R. Karst – Yesterday, Senator Sam Brownback (R-KS) (along with Sen. Sherrod Brown (D-OH)) introduced S. 3697, the Creating Hope Act of 2010. The bill would amend FDC Act § 524 to change the transferable Priority Review Voucher (“PRV”) program created by …
By Kurt R. Karst – FDA’s recent denial of a citizen petition concerning labeling carve-out issues related to the approval of generic versions of LYRICA (pregabalin) – which, by the way, contains some of the most useful insight in years into FDA’s thinking on …
By Kurt R. Karst – On August 3rd, Judge Claude Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) granted The Medicines Company’s (“MDCO’s”) Motion for Summary Judgment in a long-running dispute (involving all three branches of the federal …
By Kurt R. Karst – Last week, the Natural Resources Defense Council (“NRDC”) filed a Complaint in the U.S. District Court for the Southern District of New York against FDA in an effort to force the Agency to finalize its topical antimicrobial drug products Over-the-Counter …
By Kurt R. Karst – In a Federal Register notice scheduled for publication on August 4th, FDA will announce the Prescription Drug User Fee Act (“PDUFA”) user fee rates for Fiscal Year (“FY”) 2011. As in all previous years under the fourth iteration of PDUFA, …
On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, …
By Susan J. Matthees – POM Wonderful is still in court. The maker of POM Wonderful pomegranate juice brought suit against Coca-Cola, alleging the Coca-Cola’s Minute Maid Enhanced Pomegranate Blueberry Flavored 100% Juice Blend is misleading and deceptive to consumers because the name suggests that …
By Kurt R. Karst – On Thursday, the U.S. Senate Committee on Appropriations approved the inclusion of the “Preserve Access to Affordable Generics Act” in the report (Senate Report No. 111-238; pages 144-148 & 150-151) accompanying the Fiscal Year 2011 Financial Services and General …
By Ricardo Carvajal – FDA released a report summarizing the first seven months of the agency’s experience with its Reportable Food Registry (for more on recent developments pertaining to the RFR, see our prior posting here). The data summarized by FDA show how the potential …
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the Federal Circuit denied Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco”) and Sun Pharmaceutical Laboratories, Ltd.’s (“Sun”) Petition for Panel Rehearing and Rehearing en banc of an April 14, 2010 Federal Circuit decision in …
