By Kurt R. Karst – A lot has been happening at FDA over the past two months – and in particular in recent weeks – as the Agency works diligently to implement the Generic Drug User Fee Amendments of 2012 (“GDUFA”). There have been various …
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Prescription Drugs and Biologics
- Our GDUFA Cup Runneth Over! FDA Sets Several FY 2013 User Fee RatesOctober 25th, 2012
- Rehearing Sought in Hatch-Waxman “Safe Harbor” Case; Plaintiffs-Appellees Contend that the Federal Circuit’s Panel Decision Expands “Safe Harbor” Into a “Safe Ocean”October 23rd, 2012
By Kurt R. Karst – We were hardly surprised when we learned that Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Plaintiffs-Appellees”) filed a Petition for Rehearing en banc seeking reconsideration of an August 3, 2012 decision by a divided (2-1) panel of judges from the U.S. …
- The End of the Road: Franck’s Compounding Case is MootOctober 16th, 2012
By Kurt R. Karst & Jeffrey N. Gibbs – We’ve been following litigation involving the Florida veterinary compounding pharmacy Franck’s Lab, Inc. (“Franck’s”) for a couple of years. We won’t get into all of the case details here – for that, see our previous posts …
- “No-AG” Agreements are Anticompetitive, Says the FTC for a Second TimeOctober 15th, 2012
By Kurt R. Karst – The Federal Trade Commission (“FTC”) is seeking leave to file a second amicus brief in private antitrust litigation espousing the Commission’s views that a branded drug company’s commitment, as part of a settlement agreement, not to launch an Authorized Generic …
- Fungal Meningitis Outbreak Prompts Calls for Greater Regulation of CompoundersOctober 10th, 2012
By Kurt R. Karst – It was 50 years ago today (October 10th) that President John F. Kennedy signed into law the Kefauver-Harris Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962), which amended the 1938 FDC Act to require, among other things, …
- Actelion Preemptively Sues Generic Companies Over REMS and Biostudy Product Availability Issues; Case Could be a Bellwether for Future EffortsOctober 9th, 2012
By Kurt R. Karst – In a Complaint recently filed in the U.S. District Court for the District of New Jersey, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) seek declaratory relief that Actelion is under no duty or obligation to supply prospective …
- U.S. Supreme Court is Again Asked to Take Up Drug Patent Settlement Agreements; This Time It’s ANDROGELOctober 8th, 2012
By Kurt R. Karst – Just weeks after Federal Trade Commssion (“FTC”) Chairman Jon Leibowitz signaled in a speech that the Commission would appeal to the U.S. Supreme Court the U.S. Court of Appeals for the Eleventh Circuit’s April 2012 ruling (and subsequent July 2012 …
- What’s the Hang-up? Apotex Sues FDA Over Compliance Failure That’s Stalling ANDA ApprovalsOctober 4th, 2012
By Kurt R. Karst – Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process. This is particularly true for ANDA generic drug …
- FDA Sued Over Generic DIOVAN 180-Day Exclusivity; Lawsuit Takes Issue With FDA Forfeiture Decision and “Trust Me” Approach to Exclusivity DecisionsOctober 3rd, 2012
By Kurt R. Karst – The question was not whether, but when, FDA would be sued over a decision involving 180-day generic drug exclusivity and the so-called “failure to obtain timely tentative approval” forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV). That day has finally come. …
- New Legislation Would Provide Exclusivity Add-on for Significant Drug CombinationsOctober 2nd, 2012
By Kurt R. Karst – Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing …
- White House Releases Major Paper on Propelling Innovation in Drug Development and Recognizes HP&M’s Frank Sasinowski for ContributionsSeptember 27th, 2012
By Alexander J. Varond – On September 25, 2012, the President’s Council of Advisors on Science and Technology (“PCAST”) released a report entitled “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” PCAST is a commission of leading scientists and engineers who …
- Another Orphan Drug Battle; Depomed Sues FDA Over GRALISE Orphan Drug ExclusivitySeptember 27th, 2012
By Kurt R. Karst – Public turmoil over FDA decisions involving orphan drug exclusivity has been relatively rare in recent years. That has changed over the past several months. First there was the lawsuit brough against FDA by K-V Pharmaceutical Company to “restore” …
- Legislative Fix Would Allow FDA to Collect GDUFA User FeesSeptember 19th, 2012
By Kurt R. Karst – Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). …
- Patent Settlement Agreements: The Next BarrageSeptember 17th, 2012
By Kurt R. Karst – In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s …
- Revised Formula Yields a Lower Priority Review Voucher User Fee of $3,559,000; Will That Help Spark Greater Interest in the Program?September 12th, 2012
By Kurt R. Karst – While Congress and The White House debate whether user fees paid pursuant to various UFAs – User Fee Acts – will be sequestered under the terms of the Budget Control Act (see here), FDA continues to move forward with planning …