By Jennifer M. Thomas – You might have read in our blog post two weeks ago that Quality Egg, LLC executives Austin (Jack) and Peter DeCoster had petitioned for panel rehearing and rehearing en banc of the Eight Circuit opinion affirming their three-month prison sentences. Last …
By Anne K. Walsh & Robert A. Dormer – As we predicted it might, FDA effectively shut down a drug facility based solely on its conduct during an FDA inspection, without any observed GMP or safety concern related to the company’s products or procedures. In a …
By Kurt R. Karst – A mere 1 year and 8 months after FDA’s February 6, 2015 publication of a Proposed Rule to implement certain provisions of the December 8, 2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, and 12 years and …
By Alexander J. Varond – One day before the program’s sunset, President Obama signed a bill to temporarily reauthorize the rare pediatric disease priority review voucher program for 3 months. The program has had significant interest from industry, and the program’s extension on September 30 was …
In May, HP&M released a comprehensive FDA Deskbook, prepared by the same authors who provide the expertise and analysis contained in this blog. Since then, the Deskbook has been well-received by individuals at companies of all sizes and sophistication. HP&M has secured a 25% discount …
By Riëtte van Laack – On Sept. 27, 2016, FDA announced the availability of several documents regarding the “healthy” claim on foods. Under the current regulation, the term “healthy” (or similar terms) – when used with an explicit or implicit claim or statement about a nutrient in …
By Jenifer R. Stach – How often do we hear this familiar story: I submitted a request to FDA under the Freedom of Information Act (FOIA) but years later I have received no responsive records? Recently, two groups challenged FDA’s delays in processing FOIA requests. The court’s …
By Serra J. Schlanger & Alan M. Kirschenbaum – Judge Rya Zobel of the Federal District Court for the District of Massachusetts has dealt another blow to the Federal health care program antikickback statute (“AKS”) discount safe harbor, which drug and device manufacturers and their customers …
By Anne K. Walsh & Andrew J. Hull – A problematic decision from the Ninth Circuit appears to impermissibly grant FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. We hope other courts recognize this …
By McKenzie E. Cato* & Allyson B. Mullen – In May 2015, FDA issued a draft guidance addressing how FDA might consider patient preference information (PPI) in review of premarket approval applications (PMA), humanitarian device exemption (HDE) applications, and de novo requests; the types of data …
By Alexander J. Varond – Late last week, the Senate voted unanimously to extend the rare pediatric disease voucher program until December 31, 2016. In doing so, it also voted to amend the definition of “rare pediatric disease” set forth in Section 529 of the Federal …
By Kurt R. Karst – Last Friday, FDA announced that the Agency licensed the fourth biosimilar biological product under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”): Amgen, Inc.’s (“Amgen’s”) AMJEVITA (adalimumab-atto) (BLA 761024), a biosimilar version of AbbVie Inc.’s (“AbbVie’s”) (BLA 125057) blockbuster …
By Alexander J. Varond – FDA’s rare pediatric disease priority review voucher program is set to expire on October 1. If this happens, FDA will no longer award pediatric vouchers to otherwise eligible sponsors. Expiration of the pediatric voucher program would mean the end (at least …
By Jennifer M. Thomas – As predicted in our last post on the significant Park-related litigation arising out of the Quality Egg case, Austin (Jack) and Peter Decoster timely petitioned for panel or en banc rehearing of their Eighth Circuit challenge to three-month prison sentences imposed …
By Dara Katcher Levy & Jenifer R. Stach – Ten years and two days after FDA issued the proposed rule, the Agency published the final rule – Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a …
