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 …
By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is piqued by FDA, Congress, or by some other entity. The most recent attempt to explore the …
By Kurt R. Karst – Among the Warning Letters FDA posted on its website this week, one in particular caught our attention – a February 17, 2012 Warning Letter to Merck Sharp and Dohme Corp. (“Merck”) citing a violatation of FDC Act § 505(o)(3). FDA’s enforcement …
By Kurt R. Karst – Following the Federal Circuit’s recent precedential decision in AstraZeneca Pharms. v. Apotex et al. (Case No. 2011-1182) (in which the Court held that an ANDA sponsor who submits a “section viii” statement with respect to an Orange Book-listed method-of-use patent and does …
By Kurt R. Karst – Following a long court battle in which a three-judge panel of the U.S. Court of Appeals for the Tenth Circuit affirmed a November 2010 decision from the U.S. District Court for the District of Wyoming granting FDA’s Motion to Dismiss a …
By Kurt R. Karst – Just days after FDA announced the release of three draft guidances on biosimilar product development (see our previous post here), and on the same day FDA officially noticed their availability in the Federal Register (here, here, and here) (as well as …
By Kurt R. Karst & David B. Clissold – Three House lawmakers (Reps. Henry Waxman(D-CA), Ed Markey (D-MA), and Diana DeGette (D-CO)) sent letters (here and here) to FDA Commissioner Dr. Margaret Hamburg and NIH Director Francis Collins earlier this week expressing their concern over a …
By Kurt R. Karst – Last week, Representative Bobby Rush (D-IL) announced the introduction of H.R. 3995, the Protecting Consumer Access to Generic Drugs Act of 2012. The bill is the latest piece of legislation that attempts to stymie so-called pay-for-delay patent settlement agreements. In January …
By Nisha P. Shah – On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” The guidance is intended to help small businesses understand the …
