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 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 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 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 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 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 Kurt R. Karst – As we noted at the end of a post earlier this week (see here), we thought a lawsuit against FDA over the approval of generic versions of AstraZeneca’s quetiapine fumarate franchise – i.e., SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639) and …
By Jennifer M. Thomas & Jeffrey N. Wasserstein – Many pharmaceutical companies sponsor prescription drug coupons and other cost-savings programs to help reduce the burden of co-payments and co-insurance. Lawsuits filed against nine pharmaceutical companies in four federal district courts on March 7 by various union health …
By Kurt R. Karst – Ever since FDA came up with the idea of a so-called “180-day exclusivity punt,” the Agency has taken a shine to using it with impunity, as a quick perusal of our 180-Day Exclusivity Tracker shows. FDA’s recent approval of ANDAs for …
By Alex J. Varond - On March 5, 2012, the Department of Veterans Affairs ("VA") issued a final regulation on promotion of drug and drug-related products (i.e., supplies related to the use of a drug, such as insulin needles and inhalers) by pharmaceutical company representatives at …
By Kurt R. Karst – Last week, as Congress, FDA, and industry continue to ramp up debate on what changes or modifications should be made to the FDC Act and PHS Act as part of a user fee package of bills expected to be enacted later …
