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 …
By Kurt R. Karst – In a 33-page decision handed down late last Friday, Judge Colleen Kollar-Kotelly of the U.S. District Court for the District of Columbia denied AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) Application for Prelimiary Injunction and dismissed without prejudice the action AstraZeneca filed on March …
By JP Ellison – We previously reported on the oral arguments in the Supreme Court case Sackett v. EPA that raised the question of when agency action was sufficiently final to allow a party to seek review in federal court. Earlier this week the Supreme Court …
By Jennifer D. Newberger – On March 20, 2012, FDA published a notice in the Federal Register announcing a public meeting to discuss proposed recommendations (here and here) for the reauthorization of the Medical Device User Fee Act (“MDUFA”) for fiscal years 2013 through 2017. 77 …
By Ricardo Carvajal – A divided 6th Circuit panel affirmed a lower court’s ruling that some provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) are unconstitutional, but others are not. As we noted in a prior posting, a federal district court ruled …
By Kurt R. Karst – FDA’s issuance of three long-awaited and highly anticipated draft biosimilar guidances earlier this year (see our previous post here) seems to have hardly whet industry’s appetite for information on the Agency’s interpretation of Section 351(k) of the Biologics Price Competition and …
By Ricardo Carvajal – Linda Birnbaum, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, published an editorial discussing the most recent evidence that certain environmental chemicals, including suspected endocrine disruptors such as BPA, “can have effects that would …
By Kurt R. Karst – As myriad failure-to-warn cases against generic drug manufacturers work through the judicial system in light of the U.S. Supreme Court’s June 23, 2011, 5-4 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), as well as a recent petition …
By Larry K. Houck – The Drug Enforcement Administration (“DEA”) has published a Final Rule increasing initial registration and renewal fees for all registrants. 77 Fed. Reg. 15,234 (Mar. 15, 2011). DEA published the applicable Notice of Proposed Rulemaking (“NPRM”) on July 6, 2011, which was …
