By Dave B. Clissold – Earlier this week, FDA’s Center for Tobacco Products ("CTP") released its first determinations regarding the marketing of new tobacco products through the substantial equivalence (SE) pathway. CTP authorized the marketing of two new tobacco products and denied the marketing of …
By Jamie K. Wolszon & Alan M. Kirshenbaum ¬− On June 3, 2013, the U.S. District Court for the Southern District of New York ruled that a drug company co-pay subsidy program did not violate the Racketeer Influenced and Corrupt Organizations Act (RICO) under theories of …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Kurt R. Karst – Shortly after 10:00 AM this morning, the generic drug industry let out a collective sigh of relief. It was at that time the U.S. Supreme Court issued its highly anticipated ruling in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142). …
The National Institutes of Health ("NIH") recently launched a database of labels of dietary supplements being sold in the United States. The database includes, among other information, directions for use, ingredients, business contact information, and claims taken directly from product labels. The database can be …
By Etan J. Yeshua – FDA has announced several key areas on which it plans to focus its food- and cosmetic-related research and regulatory efforts. The plan specifically names imported foods, nanoparticles in cosmetics, dietary supplement toxicology, and obesity, among others, as specific areas of …
By Riëtte van Laack – Last week, Health Science Funding, LLC filed what might be the first medical food lawsuit against FDA. (A copy of the Complaint is available here, and a copy of the Motion for a Preliminary Injunction is available here.) Plaintiff markets what it …
By Jennifer D. Newberger – It is not often that CDRH guidance documents get much attention outside the trade press and medical device circles. So when The Wall Street Journal and The Washington Post both publish articles about a draft guidance document on the same day, …
By Jennifer D. Newberger – On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to provide clarity around certain IDE decisions, and to introduce a “voluntary program intended to facilitate the development of trial designs that may …
Transparency and data disclosure are this year’s hot issues for pharmaceutical companies. On the clinical trial front, Europe is leading the way, with initiatives from the European Medicines Agency and the European Parliament that will impact drug research and development world-wide. The proposed TEST Act …
FTC Chairwoman Edith Ramirez announced on Monday the appointment of Jessica Rich to head the agency’s Bureau of Consumer Protection ("BCP"). Ms. Rich is a 20-year veteran of the FTC with experience overseeing policy work and enforcement especially in the areas of privacy, data security, and …
By Karla L. Palmer – On Friday, June 14, 2013, Congressman Morgan Griffith (R-VA) released a draft bill addressing compounding of human drugs. The draft primarily was influenced by the revised draft guidance document the Food and Drug Administration (“FDA”) was prepared to release in …
By Kurt R. Karst – On June 17th, the U.S. Supreme Court issued its much-anticipated opinion in Federal Trade Commission v. Actavis, Inc., 570 U.S. ___ (2013) (Docket No. 12-416) concerning drug patent settlement agreements (aka “reverse payment agreements” or “pay-for-delay agreements”). In a 5-3 …
By Ricardo Carvajal – In previous postings (see here and here), we reported on the Center for Food Safety’s ("CFS’s") lawsuit seeking to compel FDA to accelerate its implementation of FSMA. In April, the presiding court ruled that FDA’s delay violated the APA and ordered …
By James E. Valentine* & David B. Clissold – The pendulum has been swinging: the medical research community and public health advocates want access to clinical trials data used to support marketing applications of FDA-regulated medical products. In 2007 that pendulum picked up momentum, with the …
