By Kurt R. Karst – In what appears to be a further sign of FDA’s efforts to clamp down on differences between brand-name Reference Listed Drugs (“RLDs”) and their proposed generic counterparts, FDA’s Office of Generic Drugs (“OGD”) is now looking more closely at tablet size …
By Kurt R. Karst – Representatives Cliff Stearns (R-FL) and Ed Towns (D-NY) recently introduced H.R. 3737, the Unlocking Lifesaving Treatments for Rare-Diseases Act (“ULTRA”). The bill would amend the FDC Act to “improve access to the existing accelerated approval pathway for patients with life threatening …
By Jennifer M. Thomas – A Government Accountability Office (“GAO”) Report released on December 15, 2011, the same day as a Senate Committee hearing, finds that FDA needs increased authority in order to address the growing problem of drug shortages. In her statement before the Senate …
By Kurt R. Karst – We had hoped that our post from earlier this week, titled Pending DESI Program Proceedings – The List, would stimulate some discussion. And it did. One comment in particular that we received from an authoritative source caught our attention and deserves greater …
By James R. Phelps – Many seasoned FDA watchers are surprised by the kerfuffle raised when HHS overturned FDA’s plan to allow Plan B emergency contraception available over the counter (see here and here). This is first time HHS has publicly put its thumb on the …
By Kurt R. Karst – For years we’ve heard rumors of a relatively current list, compiled by FDA, of proceedings pending under the Drug Efficacy Study Implementation (“DESI”) program. At one time, in the early 1980s, the list was included as an addendum to the Orange …
By Kurt R. Karst – Just one day after FDA announced a December 16th public meeting and comment period to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017 (see our post here), the …
By Kurt R. Karst – On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a …
By Kurt R. Karst – In what appears to be the second guidance of its kind, FDA proposed in a draft bioequivalence guidance document issued earlier this week that companies seeking approval to market generic versions of RITALIN LA (methylphenidate HCl) Extended-Release Capsules must, in addition …
The International Conference on Drug Development (“ICD2”), formerly known as the International Industrial Pharmacy Conference, continues its annual tradition of offering an informal forum for the exchange of ideas concerning the drug discovery and development process. The 2012 conference, which is presented by The University …
By Kurt R. Karst – Almost a year after having notified Genentech of a proposal to withdraw the approval of Avastin® (bevacizumab) for use with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer, and almost five months after …
By Kurt R. Karst – Less than a month before the U.S. Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, Docket No. No. 10-844 (see here and here), concerning whether the patent delisting counterclaim provisions at FDC …
By Kurt R. Karst – On November 16th, Senators Jeff Bingaman (D-NM), David Vitter (R-LA), Sherrod Brown (D-OH), and Jeff Merkley (D-OR) announced the introduction of the Fair And Immediate Release of Generic Drugs Act, or the “FAIR GENERxICS Act,” a draft version of which is …
By Kurt R. Karst – In a lawsuit filed in the U.S. District Court for the District of Columbia, Florida-based Hill Dermaceuticals, Inc. (“Hill”) is seeking declaratory and injunctive relief after FDA approved, on October 17, 2011, three ANDAs submitted by Identi Pharmaceuticals Inc. (“Identi”) – …
By Kurt R. Karst – Politico recently published an opinion piece authored by Federal Trade Commission (“FTC”) Chairman Jon Leibowitz, who is up for reappointment for a second term on the Commission, in which he stated he wanted to throw in his “two cents” on how …
