FDA Law Alert – February 2020

February 10, 2020

Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement activities affecting the broad cross-section of FDA-regulated industry.  As the largest dedicated FDA law firm, we are happy to help you or your clients navigate the nuances of the laws and regulations affecting them.


Medical Devices

  • Exportation: In November 2019, FDA issued final guidance on how device firms may request review of a decision to withhold issuance of a Certificate of Foreign Government (“CFG”).  A CFG provides official assurance that exported products comply with U.S. laws and regulations.  In his post, Jeff Shapiro explains the procedural rights and appeal options available through the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) for companies denied a CFG.  He further explains how FDA’s final guidance implements these procedures.
  • Enforcement: Sara Koblitz and Doug Farquhar discuss a recent success before the U.S. District Court for the District of Columbia.  The post describes a lawsuit filed by HPM on behalf of Genus Medical Technologies (“Genus”) challenging FDA’s attempt to regulate its device as a drug.  Koblitz and Farquhar provide detailed information on each parties’ arguments, the court’s reasoning for its decision in favor of Genus, and the future impact of this litigation on industry.


  • Drug Development: In this post, Larry Bauer describes FDA’s draft guidance, “FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.”  Check out the full blog post for a detailed explanation of the new requirement for pediatric investigations that involve these targeted therapies, FDA’s molecular target lists and additional considerations for rare cancers.
  • Hatch-Waxman: In this post, Kurt Karst provides an overview of The Lower Health Care Costs Act of 2019 (the “Act”).  According to Karst, the Act looks strikingly similar to the BLOCKING Act of 2019.  His post describes how the Act would significantly alter the 180-day exclusivity provisions, the incentives for such exclusivity, as well as its potential to lead to higher drug prices.


  • Qui Tam Litigation: Serra Schlanger describes the latest development in the United States ex rel. Campie v. Gilead Sciences, Inc. saga.  As False Claims Act litigators surely know, this case started back in 2010 based on allegations by two former employees that Gilead made false statements to FDA about the its anti-HIV drugs.  Schlanger details the U.S. District Court for the Northern District of California’s analysis and its ultimate decision to grant the government’s motion to dismiss.

Food & Dietary Supplements

  • CBD in Dietary Supplements: Riëtte van Laack describes recent actions taken by four major trade associations, AHPA, CRN, CHPA and UNPA, in an effort to legalize hemp-derived CBD.  For example, one such action was a letter urging Congress to pass legislation that would make hemp-derived CBD a legal dietary ingredient for use in dietary supplements. The second was a citizen petition requesting swift action from FDA, including the establishment of a regulatory pathway to legally market dietary supplements containing hemp-derived CBD and to increase enforcement actions against “unscrupulous manufacturers” of CBD-containing products that use illegal drug claims.

Animal Drug Products

  • Compounding: Karla Palmer discusses FDA’s latest revision to its draft guidance addressing compounding of animal drug products from bulk substances.  In her post, Palmer details the situations where FDA would exercise enforcement discretion, asserting that such discretion is an attempt by the Agency to expand its regulatory authority over animal drug compounding by pharmacies and veterinarians as well as veterinary medicine generally.
  • Genetically Modified Animals: Also out of the Northern District of California, a Court upheld FDA’s authority to regulate genetic material used to modify an animal as a new animal drug.  Ricardo Carvajal outlines the Court’s basis for upholding such authority through the FD&C Act and Guidance #187.  Carvajal further analyzes the implications of the Court’s decision to defer the question of whether drug safety encompasses environmental risks.


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