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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Hyman Phelps McNamara
- 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. …
- California Proposition 37’s Take On “Natural”October 23rd, 2012
By Ricardo Carvajal – As the November 6 election draws near, debate over California’s Proposition 37 is heating up. If the measure passes, genetically engineered ("GE") foods sold at retail in the state would have to be labeled as such – a requirement that would have …
- Rep. Markey Asks Department of Justice to Investigate New England Compounding Center, and to Probe into DEA’s Past Oversight of Pharmaceutical CompoundingOctober 22nd, 2012
By Karla L. Palmer & Larry K. Houck – Representative Edward Markey (D-MA) sent a written request to the U.S. Department of Justice on October 15th asking Attorney General Eric Holder to commence an investigation into whether the New England Compounding Center (“NECC”) violated the …
- DEA Takes Further Action on Scheduling And Control of Synthetic CathinonesOctober 21st, 2012
By Karla L. Palmer & Delia A. Stubbs – Last week, DEA continued the temporary scheduling of a single synthetic cathinone, methylone (3, 4-methylenedioxy-N-methylcathinone) in Schedule I of the Controlled Substances Act (“CSA”). The temporary scheduling will expire on April 20, 2013, or upon completion of …
- 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 …
- Lawmakers’ Concerns Highlight DEA Deficiencies in Establishing Clear Requirements for Identifying and Reporting Suspicious OrderOctober 14th, 2012
By John A. Gilbert, Jr. & Larry K. Houck – A bipartisan group of thirteen congressional representatives penned a letter to Administrator Michele Leonhart last week requesting “clarification, guidance and collaboration” about the Drug Enforcement Administration’s (“DEA’s”) efforts to combat prescription drug abuse. While voicing …
- FDA Petitions D.C. Circuit for Rehearing on Cigarette Graphic WarningsOctober 12th, 2012
By Ricardo Carvajal – A few weeks ago, we posted on a decision by a divided three-judge panel of the D.C. Circuit Court of Appeals vacating FDA’s regulations that require graphic warnings on cigarette packages (see here). FDA has now petitioned the D.C. Circuit Court of …
- USP Recognizes Work of Food Ingredients Expert CommitteeOctober 11th, 2012
The U.S. Pharmacopeial Convention (“USP”) recently announced at an Awards and Recognition Program for USP Expert Volunteers that the 2012 USP Award for an Innovative Response to Public Health Challenges went to the Food Ingredients Expert Committee. Hyman, Phelps & McNamara, P.C. Director Diane B. …
- 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 …
- A Difference of Opinion: CDRH’s SOP for Internal Supervisory AppealsOctober 8th, 2012
By Jeffrey K. Shapiro & Jessica A. Ritsick – Under FDA’s regulations (10 C.F.R. § 10.75), the decision of an FDA employee (other than the Commissioner) is subject to supervisory review in four circumstances: (1) when an employee so requests; (2) when a supervisor initiates review; …
- 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 …
- Who Should Regulate Medical Mobile Apps? FDA or Some Other HHS Agency?October 4th, 2012
By Carmelina G. Allis – Should FDA’s Center for Devices and Radiological Health (“CDRH”) regulate medical mobile apps? Or should medical mobile apps be regulated by another office within FDA? Or should they be regulated by a separate entity under the Department of Health and …