By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Kurt R. Karst – FDA’s recent approval of ANDAs for generic versions of sanofi-aventis’ (“sanofi’s”) blockbuster blood thinner drug PLAVIX (clopidogrel bisulfate) Tablets (approved under NDA No. 020839) upon the May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent …
By Michelle L. Butler – Abbott Laboratories (“Abbott”) recently submitted a citizen petition to FDA regarding biosimilars under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Specifically, the citizen petition requests that FDA not accept for filing, file, approve, or discuss with any company …
By Kurt R. Karst – A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011. At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR). Petitions, FDA decisions, lawsuits, …
By Kurt R. Karst – Two new reports were published this week analyzing FDA’s performance under the Prescription Drug User Fee Act (“PDUFA”). The reports – one from the California Health Institute (“CHI”) and The Boston Consulting Group (“BCG’), and another from the Tufts Center for …
By Kurt R. Karst – Following the recent decision by the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical Co., which our friends over at the Drug and Device Law Blog commented on as making no sense (“while a simple warning …
By Kurt R. Karst – On Tuesday, May 8th, the House Energy and Commerce Committee, Subcommittee on Health is scheduled to hold a markup session to consider draft legislation to ensure the continuation of existing FDA user fee programs (i.e., PDUFA and MDUFA) and the creation …
By Alan M. Kirschenbaum – On May 3, 2012, CMS posted on its website a notice announcing that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before January 1, 2013. As we have …
By Kurt R. Karst – Representative Tom Reed (R-NY) recently introduced legislation (H.R. 5283) that is intended to clarify that the PHS Act’s clinical trial registry data bank reporting requirements apply to clinical trials regardless of a trial’s outcomes. The bill would also amend the PHS …
By Kurt R. Karst – A report released earlier this week by the Government Accountability Office (“GAO”) says that FDA has met most of the Agency’s PDUFA performance goals for priority and standard original NDA and BLA submissions and for priority and standard original efficacy supplements …
By Nisha P. Shah – FDA issued a final rule that amends the regulations to expand the scope of disqualification of clinical investigators. 77 Fed. Reg. 25353 (Apr. 30, 2012). We previously reported on the proposed rule issued in April 2011, and there are no substantive …
By Kurt R. Karst – In yet another decision out of the U.S. Court of Appeals for the Eleventh Circuit concerning patent settlements (or what opponents refer to as "pay-for-delay" deals), the Court affirmed a February 2010 decision by the U.S. District Court for the …
By Jennifer D. Newberger – On Tuesday, April 17, 2012, Senators Burr and Coburn introduced the Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act, or the “PATIENTS’ FDA Act.” This bill is intended to complement the proposed user fee agreements negotiated between FDA and …
By Kurt R. Karst – Carrying through on his promise to introduce legislation to legislatively overturn the U.S. Supreme Court’s June 23, 2011 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), Senator Patrick Leahy (D-VT), along with co-sponsor Sens. Al Franken (D-MN), Jeff …
