By Kurt R. Karst – Section 11 of the Best Pharmaceuticals for Children Act (“BPCA”) of 2002 amended the FDC Act to add a new provision, which was reauthorized under the FDA Amendments Act of 2007 and is located at FDC Act § 505A(o), to …
Menu
Hyman Phelps McNamara
- BPCA Section 11 and Pediatric Labeling; Revised Labeling Carve-Out Citizen Petition ScorecardJune 22nd, 2009
- The United States Files Criminal Charges Against Orthopedic Device Manufacturers and Four ExecutivesJune 18th, 2009
By Carmelina G. Allis – We previously reported that the State of New Jersey had entered into an agreement with Synthes, Inc. to settle allegations that the company failed to disclose financial conflicts of interest among doctors who conducted clinical testing on its products. Now, …
- Pet Food Business Owners Plea to FDC Act Misdemeanors in Connection with Pet Food ScandalJune 17th, 2009
JP Ellison – The U.S. Attorney's Office for the Western District of Missouri announced three guilty pleas to misdemeanor violations of the FDC Act in connection with the "nationwide recall of pet food and the death and serious illness of countless pets across the United States …
- Reportable Food Registry Will be Operational in September 2009June 17th, 2009
By Riëtte van Laack – The FDA Amendments Act (“FDAAA”) amended the Food, Drug, and Cosmetic Act (“FDC Act”) to create section 417, which directs FDA to establish a Reportable Food Registry (“Registry”). The purpose of the Registry is to provide a “reliable mechanism to …
- Will FDA Apply a Presumption in Favor of NCE Status for Pancreatic Enzyme Products?June 16th, 2009
By Kurt R. Karst & Frank J. Sasinowski – FDA’s recent decision to approve the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) to help patients with cystic fibrosis and others with Exocrine Pancreatic Insufficiency (“EPI”) digest and absorb nutrients from foods has apparently left the Agency …
- Federal Judge Rejects Effort to Invoke First Amendment to Overcome Misbranding and Fraud Indictment; Holds that Press Release in Case is LabelingJune 15th, 2009
By Jamie K. Wolszon – Earlier this month, a U.S. District Court for the Northern District of California judge refused to dismiss a criminal indictment of the former Chief Executive Officer (“CEO”) of InterMune for misbranding and wire fraud charges connected to the off-label promotion …
- FDA Takes Canned Pet Food Processor Off-LineJune 15th, 2009
By Ricardo Carvajal – In an increasingly common exercise of the agency’s authority under FDC Act § 404, FDA announced that is has it has suspended the temporary Emergency Permit issued to Evanger's Dog & Cat Food Co., Inc. in April 2008. Under § 404 …
- FDA’s Holding-on-the-Merits Standard – Will it Apply Post-MMA?June 14th, 2009
By Kurt R. Karst – Will FDA apply the Agency’s pre-Medicare Modernization Act (“MMA”) “holding-on-the-merits standard” to the post-MMA “failure to market” 180-day exclusivity forfeiture provisions? It is a reasonable question, and one that FDA has not yet definitively answered. Nevertheless, there appears to be …
- Congress Passes The Family Smoking Prevention and Tobacco Control Act; HP&M Analysis to FollowJune 12th, 2009
On June 12th, the U.S. House of Representatives voted 307-97 on final passage of H.R. 1256 – The Family Smoking Prevention and Tobacco Control Act. The U.S. Senate overwhelmingly passed the bill on June 11th with a 79-17 vote. President Obama is expected to sign …
- With Draft Food Safety Legislation, Heavy Burdens All AroundJune 11th, 2009
By Ricardo Carvajal – Much ink has already been spilled detailing the burdens that draft federal food safety legislation would impose on industry (click here for the latest version of the Food Safety Enhancement Act of 2009 (“FSEA”)). Little has yet been said about the burdens …
- FTC Issues Highly Anticipated Report on Follow-On Biologics; Report Concludes that Special Legislative Exclusivity Incentives are Largely Unwarranted for Innovators and GenericsJune 10th, 2009
By Kurt R. Karst – On June 10th, the Federal Trade Commission (“FTC”) announced the release of its highly anticipated report on Follow-On Biologics (“FOBs”). The 120-page report, titled “Emerging Health Care Issues: Follow-On Biologic Drug Competition” is the product of an FTC Roundtable held …
- Multiple PTEs; Federal Circuit Decision in Generic OMNICEF Litigation Puts the Issue on Hold for Another DayJune 8th, 2009
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit’s recent decision in Abbott Labs. v. Sandoz, Inc. concerning U.S. Patent No. 4,935,507 (“the ‘507 patent”) covering OMNICEF (cefdinir) has been discussed at length in the blogosphere for its possible implications …
- Galderma Submits New QI Act 30-Month Stay Citizen Petition; a New Variation on an Old ThemeJune 4th, 2009
By Kurt R. Karst – Galderma Laboratories L.P. (“Galderma”) recently submitted a citizen petition to FDA (also see our Citizen Petition Tracker) requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval of …
- PhotoCure and Wyeth District Court PTE Decisions Appealed to the Federal Circuit; Effects of the PhotoCure Decision are Already EvidentJune 4th, 2009
By Kurt R. Karst – Recent decisions by the U.S. District Court for the Eastern District of Virginia and the U.S. District Court for the District of Columbia in PhotoCure ASA v. Dudas and Wyeth Holding Corp. v. United States, respectively, concerning certain Patent Term Extension …
- FDA Establishes Task Force to Increase Transparency; Will Hold June 24th Meeting to Gather ViewpointsJune 3rd, 2009
By Jamie K. Wolszon – FDA has announced the establishment of a cross-agency task force to craft recommendations on how to increase transparency regarding the agency’s operations, activities, processes and decisionmaking, including product approvals, enforcement actions, and product recalls, while protecting confidential information. The agency …