By Kurt R. Karst – The growing application backlog and median time for ANDA approval by FDA’s Office of Generic Drugs (“OGD”) has been a thorn in the side of the generic drug industry for quite some time now. As we previously reported, the …
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Hyman Phelps McNamara
- Blown 30-Month ANDA Tentative Approval and Approval Dates – A Growing Industry Concern; Is Litigation in the Works?May 11th, 2010
- (877)RX-DDMAC – What Happens in the Doctor’s Office, May Not Always Stay in the Doctor’s OfficeMay 11th, 2010
By Dara Katcher Levy – On May 11, FDA announced the launch of the “Bad Ad Program,” an effort to educate Health Care Professionals on misleading prescription drug promotion and provide them with an easy way to report it (just dial 877-RX-DDMAC). The program, which …
- FDA Posts its First Dietary Supplement GMP Warning LetterMay 10th, 2010
By Ricardo Carvajal & Wes Siegner – FDA recently posted what appears to be the first warning letter to a firm for violations of the dietary supplement good manufacturing practice ("GMP") regulations in 21 CFR Part 111. The warning letter marks a point of transition …
- Federal Circuit Affirms Two District Court Decisions Concerning PTE Availability; Decisions Embrace an “Active Ingredient” Approach to PTEsMay 10th, 2010
By Kurt R. Karst – On May 10, 2010, a 3-judge panel of the U.S. Court of Appeals for the Federal Circuit (Circuit Judges Newman, Rader, and Linn) issued its unanimous decisions in two cases that should solidify as to when a patent covering …
- After Five Years, FDA Takes Initial Steps to Use Sanitary Food Transport AuthorityMay 6th, 2010
By Riëtte van Laack – In 2005, the Sanitary Food Transportation Act of 2005 (“SFTA”) was enacted. This law shifted responsibility for safe transportation of food from the U.S. Department of Transportation to FDA. Among other things, the SFTA amended the FDCA to include section …
- DDMAC Digs Deep to Link Unbranded Websites to Violative Promotional PracticesMay 5th, 2010
By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance websites”), which included disease-state information and clinical data about gastrointestinal stromal tumors (“GIST”) and chronic …
- It’s Not A Section 518 Mandatory Recall, But The Baxter Infusion Pump Recall Comes CloseMay 5th, 2010
By Jeffrey K. Shapiro – On May 3, FDA announced that it has ordered Baxter to recall and destroy an estimated 200,000 Colleague infusion pumps in use, reimburse customers for the “value” of the recalled device, and assist in finding a replacement. The press release …
- U.S. Sentencing Commission Adopts Amendments to Organizational Guidelines But Does Not Adopt Changes That Would Have Negatively Impacted Companies Regulated by FDAMay 4th, 2010
By Peter M. Jaensch – On Friday, April 30th, 2010, the U.S. Sentencing Commission sent Congress amendments to the federal Sentencing Guidelines applicable to organizations such as corporations. On January 21, 2010, we reported on proposed changes to the federal Sentencing Guidelines. The changes would have apparently …
- A New Hope? Second Circuit Invites Further Review in CIPRO Patent Settlement CaseMay 4th, 2010
By Kurt R. Karst – Last week’s decision by a 3-judge panel of the U.S. Court of Appeals for the Second Circuit in In re: Ciprofloxacin Hydrochloride Antitrust Litigation affirming a 2005 decision by the U.S. District Court for the Eastern District of New York …
- Federal Circuit Sides with FDA and PTO in CYDECTIN PTE Decision; Court Rules that Approval Phase Begins when Administrative NADA is Initially SubmittedMay 3rd, 2010
By Kurt R. Karst – Earlier today, the U.S. Court of Appeals for the Federal Circuit ruled 3-0 to affirm a March 2009 decision from the U.S. District Court for the District of Columbia granting summary judgment to FDA and the U.S. Patent and Trademark …
- CMS Issues Proposed Guidance on Part D Coverage Gap DiscountMay 2nd, 2010
By Alan M. Kirschenbaum – Five weeks after the enactment of health care reform, CMS has, with surprising alacrity, issued a draft guidance on one of the provisions of the legislation that will be most costly to brand drug manufacturers – the Medicare Part D …
- Smaller Cigarette Manufacturers Challenge Constitutionality of FDA’s Restriction on Certain Product NamesApril 30th, 2010
By Ricardo Carvajal – Some smaller cigarette manufacturers have sued FDA to invalidate a provision in FDA’s recently issued final rule that would restrict a manufacturer from using certain product names on the ground that the restriction violates the First and Fifth Amendments, among other …
- Voluntary Front-of-Pack Food Labeling: A Way to Combat the Obesity Epidemic?April 27th, 2010
By Cassandra A. Soltis – That’s what the Food and Drug Administration (“FDA”) is hoping anyway. In a notice expected to be published in the Federal Register on Thursday, April 29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” …
- NAD Takes a Crack at BioavailabilityApril 26th, 2010
By Cassandra A. Soltis – In an advertising challenge brought by the Perrigo Company (“Perrigo”), the National Advertising Division (“NAD”) of the Better Business Bureau recommended that Pharmavite, LLC (Pharmavite) refrain from making several claims for its Nature Made® Prenatal + DHA Liquid Softgel Vitamins …
- FTC Annual Report Highlights the Commission’s Patent Settlement EffortsApril 25th, 2010
By Kurt R. Karst – Last Friday, at the American Bar Association’s Section of Antitrust Law Spring Meeting in Washington, D.C., Federal Trade Commission (“FTC”) Chairman Jon Leibowitz issued the FTC’s 2010 Annual Report. Among other things, including allegedly false or unsupported claims concerning dietary …