By Kurt R. Karst – In what might be the longest citizen petition response of all-time (87-pages!), FDA, on April 9, 2012, largely denied a March 17, 2006 petition for stay of action (here and here) (Docket No. FDA-2006-P-0007) submitted by ViroPharma Incorporated (“ViroPharma”) concerning the …
By Ricardo Carvajal – Warning letters issued by FDA since late February provide an indication of the types of violations that could trigger reinspection fees under the authority provided by the Food Safety Modernization Act (“FSMA”). As we noted in a prior blog posting, FSMA authorized …
By Kurt R. Karst – It was yet another exciting day in the Hatch-Waxman world when news broke Wednesday morning that Teva Pharmaceuticals USA, Inc. (“Teva”) and Cephalon, Inc. (“Cephalon”) filed a Complaint and Motions for a Temporary Restraining Order and Preliminary Injunction against FDA in …
By Carmelina G. Allis – In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and …
By Kurt R. Karst – We recently got our hands on a copy of the latest report FDA submitted to Congress on citizen petitions covered by FDC Act § 505(q). The report, titled “Third Annual Report On Delays In Approvals Of Applications Related To Citizen …
By Riëtte van Laack – On March 30, FDA denied a petition submitted by the Natural Resources Defense Council ("NRDC") to ban bisphenol A ("BPA") in food packaging. As FDA explains in its 15-page response, the science NRDC presented in the petition was insufficient to support a conclusion …
By David B. Clissold & Ricardo Carvajal – Last Friday, the FDA Center for Tobacco Products announced two new draft guidance documents for tobacco products. The first guidance, entitled “Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the …
By Kurt R. Karst – Fans of Saturday Night Live know popular Weekend Update correspondent Oscar Rogers (played by Kenan Thompson) and his three-step approach to addressing important issues of the day: Step 1: Fix. Step 2: It. Step 3: FIXIT! That approach sums up the …
By Alan M. Kirschenbaum – Two days ago, during argument before the Supreme Court on the Affordable Care Act ("ACA"), Justice Breyer referred to “loads” of miscellaneous provisions of the Act outside the core insurance provisions. One of these is section 6004, which requires manufacturers and …
By Kurt R. Karst – Last week, the New York Times ran an editorial calling on Congress to enact legislation to address the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011). In Mensing, the Court ruled …
By Kurt R. Karst – In litigation that moved at breakneck speed on March 28, 2012, Judge Beryl A. Howell of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Motion for Temporary Restraining Order (Complaint here) seeking to vacate FDA’s …
By Jennifer D. Newberger – On March 27, 2012, FDA announced the release of a final guidance document, “Factors to Consider When Making Benefit-Risk Determination in Medical Device Premarket Approval and De Novo Classifications.” (A copy of FDA's March 28, 2012 Federal Register notice announcing the …
By Kurt R. Karst – In a decision and accompanying Order handed down on March 27, 2012, Judge Richard J. Leon of the U.S. District Court for the District of Columbia ordered that FDA “immediately notify any and all state correctional departments which it has reason …
By Kurt R. Karst – In a decision that if left intact could have far-reaching implications for FDA, the U.S. District Court for the Southern District of New York recently granted a Motion for Summary Judgment filed by the National Resources Defense Council (“NRDC”) and three other …
By Carmelina G. Allis – Amid recent reports alleging safety and effectiveness issues with a number of implant devices, a bipartisan group of Senators have introduced a bill entitled the “Ensuring Safe Medical Devices for Patients” (S. 2193). This bill is intended to strengthen FDA’s postmarket surveillance …
