FDA Law Alert: Issue #2

August 7, 2019

Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a 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 the industry.

Cross-Cutting Issues

  • Disclosure of Confidential Information
    • A recent Supreme Court decision lowers the standard for the government to withhold from disclosure confidential commercial or financial information it receives from regulated industry.  In their post, Anne Walsh and Ricardo Carvajal describe the impact that the Court decision will have on FDA-regulated entities who routinely submit this type of information to FDA.
  • Enforcement Discretion
    • Douglas Farquhar discusses FDA’s power to exercise enforcement discretion.  His post focuses on a recent court decision holding that FDA cannot delay or relax enforcement requirements mandated by the Tobacco Control Act, and must require manufacturers of tobacco and other nicotine products to submit applications to market those products.


  • Drug Development
    • In this post by Frank Sasinowski and James Valentine, they highlight the approval of the first systemically administered somatic gene replacement therapy. The approval of Avexis’s Zolgensma (onasemnogene abeparvovec-xioi), for treatment of spinal muscular atrophy (SMA), is a milestone for personalized medicine that targets the root causes of genetic diseases using gene replacement.
  • Biosimilars
    • FDA finalized its guidance to assist biosimilar manufacturers to demonstrate interchangeability with a reference product.  Sara Koblitz writes about activities since the draft guidance was issued in 2017 and the potential impact the final guidance will have on drug manufacturers seeking to establish interchangeability.


  • PMA Panels
    • Jeff Gibbs and McKenzie Cato take a close look at the relationship between the outcomes of FDA advisory panels to review pre-market applications (PMAs) and the ultimate outcomes and time to resolution of PMAs.  Their post discusses why the relationship may not be clear cut.
  • Unique Device Identification (UDI)
    • FDA finalized its guidance for industry on UDI labeling requirements applicable to convenience kits (two or more medical devices packaged together for the convenience of the user).  Rachael Hunt compares the draft guidance with the final version and describes scenarios to illustrate its application.
  • Off-Label Promotion and Reporting Violations
    • Anne K. Walsh and Adrienne Lenz describe the woes of a device manufacturer held accountable for civil and criminal violations related to its wound dressing product.  Not only does this case highlight the steep penalties associated with reporting violations — a $3 million criminal fine in this case – but it also shows that off-label promotion remains a targeted area of interest for the government.


  • 180-Day Exclusivity
    • Kurt R. Karst continues his coverage of the BLOCKING Act, legislation that could make 180-day exclusivity eligibility unpredictable for ANDA applicants.  In this latest post, Karst details two alternative versions of the bill that could maintain the 180-day incentive, but would address FDA’s concerns about competition and pricing for drugs.


  • Fraud and Abuse
    • In response to objections that the restrictions were too prohibitive, New Jersey amended its rules regarding the acceptance of remuneration by prescribers from pharmaceutical manufacturers.  Alan Kirschenbaum summarizes the significant changes from the original rule in his post.

Foods and Dietary Supplements

  • Product Labels
    • Riёtte van Laack writes in her post about FDA’s letter to industry supporting the inclusion of a “Best if Used by” statement on food products, but notes that FDA cannot enforce this requirement on foods.
  • DMHA Regulation
    • Hi-Tech Pharmaceuticals, Inc. recently sued FDA to stop enforcement activities around DMHA-containing products, arguing FDA has not undergone formal rulemaking as required by the Administrative Procedure Act.  Ricardo Carvajal and JP Ellison are following this litigation here.

DEA and Cannabis

  • Medical Cannabis  
    • John Gilbert and Larry Houck describe proposed legislation that would compel DEA to issue more marijuana manufacturer registrations for research.  Their post walks through federal regulation of studies involving the potential medical utility of marijuana and the current requirements for these manufacturers.