By Ricardo Carvajal – That’s the clever title of a symposium on entomophagy being delivered at the next annual meeting of the Entomological Society of America (ESA), scheduled for the week of November 16 in Portland, Oregon. As we noted in a prior posting, the market for insect-derived …
By Jay W. Cormier & Alan M. Kirschenbaum – As we previously reported, in late August, the U.S. District Court for the District of Columbia denied PhRMA’s request that the Court vacate a recent HRSA interpretive rule on the orphan drug exception under the 340B drug …
By Kurt R. Karst – For several months now we have been monitoring an appeal to the U.S. Court of Appeals for the Federal Circuit concerning a patent – U.S. Patent No. 6,878,703 (“the ‘703 patent”) – listed in the Orange Book for Daiichi Sankyo Inc.’s …
By Kurt R. Karst – In recent comments submitted to FDA, the American Academy of Pediatrics (“AAP”) is taking a stand against the relief requested in a June 2014 Citizen Petition (Docket No. FDA-2014-P-0830) submitted on behalf of Merz North America. The petition calls into question …
By Alan M. Kirschenbaum & David C. Gibbons – On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Proposed Rule to amend the safe harbor regulations under the Federal health care program antikickback statute (“AKS”) (42 …
By Kurt R. Karst – Last Friday morning (October 10th) something interesting popped up out of the blue on FDA’s “What’s New Related to Drugs” webpage: the final version of FDA’s “Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.” But …
Hyman, Phelps & McNamara, P.C., jointly with Barton & Blank LLC, will present a webinar on Tuesday, October 21, 2014 from Noon – 1:30 PM (Eastern Standard Time), titled “Medical Device Promotion on Social Media: Regulatory Considerations and Best Practices.” Social Media is increasingly being adopted …
By Andrew J. Hull* & William T. Koustas – FDA has published its second draft guidance in a much-awaited series of industry guidance documents related to the implementation of the Drug Supply Chain Security Act ("DSCSA"), enacted on November 27, 2013. (We posted on the first …
The International Society of Regulatory Toxicology and Pharmacology (“ISRTP”) will be holding a Workshop on GRAS Determinations from October 13-14, 2014 at the ASEA Conference Center in Washington, DC. The workshop provides a forum for leading scientific experts to contribute to the ongoing debate prompted …
By Kurt R. Karst – Colchicine is one of those drugs that has a long and storied history at FDA. It’s an old drug (about 200 years old) that was marketed for decades without FDA approval. Then, in 2009, FDA approved Mutual Pharmaceutical Company, Inc.’s (and …
By Jennifer D. Newberger – In our previous posts (here and here) regarding FDA’s approach to cybersecurity in medical devices we noted that, while neither FDA nor industry was aware of any actual intentional, malevolent software breaches that led to patient harm, FDA seemed to be …
By Jamie K. Wolszon – On September 25, 2014, the U.S. District Court for the Northern District of Illinois Eastern Division dismissed a claim that a drug company co-pay subsidy program (also known as coupon program) violated the Racketeer Influenced and Corrupt Organizations Act (RICO) under theories …
By Jennifer M. Thomas – We wanted to briefly update our readers on a case we blogged about in February of this year, United States ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014). To recap, in Omnicare the Fourth Circuit affirmed …
By Ricardo Carvajal & Diane B. McColl – In Part 1 of our effort to characterize the principal errors and mischaracterizations underpinning attacks on the GRAS exception, we focused on misrepresentations of the Food Additive Amendment’s legislative history and of the difficulties FDA allegedly faces in …
By Jennifer D. Newberger – On September 30, 2014, the Centers for Medicare & Medicaid Services (“CMS”) released for public review the first round of Open Payments (more commonly known as “Sunshine”) data. According to CMS, the Sunshine data is intended to “help consumers understand the …
