By Nisha P. Shah – On July 8, 2012, Massachusetts Governor Deval Patrick signed H. 4200, which, in part, relaxes: (1) the state anti-kickback law to permit the offering of coupons for prescription drug and biological products, and (2) the marketing laws to allow prescription drug …
By Kurt R. Karst – FDA’s Office of Generic Drugs (“OGD”) will have a new leader beginning next week. On July 13th, Helen Winkle, Director of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research, in which OGD is housed, announced that Gregory …
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 Jamie K. Wolszon – Five years ago, Congress passed the FDA Amendments Act of 2007 (“FDAAA”), requiring FDA to promulgate regulations establishing a Unique Device Identifier (“UDI”) system to facilitate adverse event and recall tracking. Under FDAAA, the UDI regulations must require an identifier on …
By Ricardo Carvajal – We raised this question at the recent ABA Section of Litigation Food & Supplements Second Annual Workshop as a way of commenting on emerging threads of resistance to the imposition of greater food safety-related requirements at all levels of government, but especially …
By Ricardo Carvajal – In several letters issued to trade associations on June 18th (for an example, see here), FDA stated that it “will expect to enforce compliance” with the preventive controls provision in section 103 of the Food Safety Modernization Act ("FSMA") and the foreign …
By JP Ellison & Jennifer M. Thomas – If you have ever sat in a meeting, received a letter or brief, or otherwise heard an interpretation from a regulatory agency that surprised, confounded or frustrated you, then you should read the Supreme Court’s recent decisions in …
