By Alexander J. Varond – After more than three years, FDA approved a class-wide Risk Evaluation and Mitigation Strategy (“REMS”) for extended-release and long-acting (“ER/LA”) opioid analgesics on July 9, 2012. The ER/LA opioid REMS applies to more than 20 companies and 30 products, and while …
Earlier this week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (usually pronounced “fuh-day-zha”). In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDASIA establishes new user fee statutes for …
By Douglas B. Farquhar – In a long-awaited ruling, a federal judge has upheld FDA’s decision to grant approval to the generic version of Xibrom®, an ophthalmic product for treatment after cataract surgery (active ingredient: bromfenac). The opinion was issued Monday by Judge James Gwin of the …
By Kurt R. Karst – In a decision that, unless appealed, marks the end of AstraZeneca Pharmaceuticals LP’s (“AstraZeneca’s”) battle with FDA over the approval of generic versions of the company’s blockbuster antipsychotic drug SEROQUEL (quetiapine fumarate) Tablets, the U.S. District Court for the District of …
By Kurt R. Karst – In a rare lawsuit against FDA involving the Orphan Drug Act of 1983, as amended, K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”), filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the …
By Kurt R. Karst – In a notice that will publish in the Federal Register later this week, FDA, citing safety concerns, will announce the Agency’s plans to take enforcement action against all unapproved single-ingredient, immediate-release human drug products containing Oxycodone HCl for oral administration, and …
By Kurt R. Karst – Earlier this week, the Presidential Commission for the Study of Bioethical Issues (“Commission”) announced in a Federal Register notice that it is seeking comment on several ethical issues associated with the development of medical countermeasures for children. The announcement …
By Kurt R. Karst – We’ve been wondering for a while now when FDA might be asked in a public forum to decide on the issue of whether a “first applicant” eligible for a period of 180-day generic drug marketing exclusivity has forfeited such eligibility if …
By Kurt R. Karst – In a June 25th decision from Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia, the court gave a mixed bag ruling on Cross-Motions for Summary Judgment (here and here) filed by FDA …
By Kurt R. Karst – Nearly seven years after having received a citizen petition (FDA Docket No. FDA-2005-P-0120) requesting that FDA apply more stringent and unconventional bioequivalence requirements (and twice supplemented – here and here – along the way) before approving generic versions of ADDERALL XR …
By Kurt R. Karst – We’re always interested in cases where things, at first glance, just don’t seem to add up. If we cannot find an explanation, we may put the case to the side for a while, and wait until an explanation becomes available. That’s …
By Kurt R. Karst – Over the past year or so, we’ve seen a change in FDA policy concerning what approvals the sponsor of a 505(b)(2) NDA can cite in an application; that is, what previous FDA approvals a 505(b)(2) sponsor can rely on for the …
By Kurt R. Karst – A new article, titled “Citizen Petitions: An Empirical Study,” analyzes citizen petitions submitted to FDA between 2001 and 2010 and concludes that petitions submitted to FDA concerning drug products are on the rise and show no signs of abating. The paper, …
By Anne Marie Murphy & Benjamin K. Wolf* – On June 12, 2012, FDA announced the availability of a draft guidance, titled “Considerations When Transferring Clinical Investigation Oversight to Another IRB” (“FDA Draft Guidance”). This is the first time FDA has provided through guidance specific direction …
By Kurt R. Karst – In a move that brings to mind Scene 2 of Monty Python and the Holy Grail, in which a mortician roams the streets ringing a bell and calling out “Bring out your dead!” (a close second being the Monty Python “Dead …
