By Larry K. Houck – Senators Orrin Hatch (R-UT) and Sheldon Whitehorse (D-RI) introduced legislation on July 25, 2012, that would amend the definition of “anabolic steroid” under the Federal Controlled Substances Act (“CSA”) and expressly add twenty-seven additional anabolic steroids to schedule III. The …
By William T. Koustas – We have been following the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA for over two years (see here, here, here, here, and here. On Monday, the United State District Court for the District of Columbia ruled in favor of FDA …
By Kurt R. Karst – Last week, Representative William Keating (D-MA) announced the introduction of new legislation – the Stop Tampering of Prescription Pills Act of 2012, or STOPP Act (H.R. 6160) – that is intended to direct companies “to invest in research and production to …
By Jennifer D. Newberger – The pre-Investigational Device Exemption ("IDE") program, established in 1995, was originally intended as a way for sponsors to obtain FDA feedback on future IDE applications. Over time, the program expanded to include feedback on other submissions, such as premarket approval ("PMA") applications, …
By Ricardo Carvajal – FDA published a Federal Register notice announcing the filing of Rep. Edward J. Markey’s food additive petition asking the agency to amend its regulations “to no longer provide for the use of Bisphenol A (BPA)-based epoxy resins as coatings in packaging for …
By JP Ellison – In a July 3, 2012 memorandum opinion out of the Eastern District of Pennsylvania, the court granted in part and denied in part the defendants’ motion to dismiss the plaintiff’s claims for failure to state a claim. The case, United States of …
By Benjamin K. Wolf* & John R. Fleder – Dr. Glen R. Justice, a 67 year old oncologist and hematologist, pleaded guilty to defrauding government, public and private insurers out of at least $400,000. The government alleged that Dr. Justice billed for treatments either not given …
By Riëtte van Laack – As we anticipated, both the FTC Staff and POM Wonderful appealed the May 17, 2012 Initial Decision by the FTC’s Administrative Law Judge (ALJ). Among other things, the FTC Staff appealed the ALJ’s conclusion that substantiation of disease efficacy claims does …
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 …
