FDA Law Alert

March 21, 2019

Hyman, Phelps & McNamara, P.C. is pleased to present the inaugural issue of its FDA Law Alert, a quarterly newsletter intended to highlight posts from our popular FDA Law Blog.  Please do not hesitate to call any of the authors identified below to discuss these issues, or any other issue affecting FDA- and DEA-regulated entities.  As the largest dedicated FDA law firm, our technical expertise and industry knowledge are exceptionally wide and deep.  We are happy to help you or your clients navigate the nuances of these laws and regulations.



  • Expanded Access: Deborah L. Livornese describes in her post FDA’s forthcoming expanded access program modifications and initiatives as well as FDA’s recognition of companies’ concerns about how adverse events related to expanded access might complicate the approval process.
  • Regenerative Medicine: James E. Valentine, Josephine M. Torrente, Jeffrey K. Shapiro and Sarah L. Wicks compare draft and final versions of CBER’s two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents in their post, specifically highlighting the types of therapies which are eligible for the RMAT designation program and the preliminary clinical evidence required to warrant expedited development and review.

Medical Devices

  • Laboratory Developed Tests (“LDT”): Allyson B. Mullen and Jeffrey N. Gibbspost describes how changes to the LDT regulatory framework are being considered by Congress through the Verifying Accurate Leading-edge IVCT Development (“VALID”) Act of 2018.
  •  Medical Device Regulations: Jeffrey K. Shapiro’s post responds to a Washington Post op-ed alleging that FDA allows doctors to implant untested devices into patients’ bodies in order to educate readers on device regulation as well as the benefits and costs of the device regulation system. 
  • Enforcement: Anne K. Walsh describes the criminal case brought against a medical device manufacturer and its quality manager for failing to file adverse event reports, highlighting the steep risk of failing to meet FDA’s regulatory requirements.


  • 180-Day Exclusivity: Kurt R. Karst describes in his post concerns with the BLOCKING Act, particularly how the Act makes 180-day exclusivity eligibility unpredictable for ANDA applicants and how factors that can lead to the triggering of exclusivity under the proposed legislation are not readily available to the public. 
  • Competitive Generic Therapy: Sara W. Koblitz’s post describes FDA’s guidance on Competitive Generic Therapy (“CGT”) which provides procedural steps that generic manufacturers must undertake to take advantage of the statutorily enacted CGT designation and related exclusivity.


  • Monographs: Riёtte van Laack and Deborah L. Livornese describe in their post FDA’s announcement in seeking data, comments, and information related to the assessment of safety and effectiveness of food handler antiseptic drug products for over-the-counter use.


  • CMS Reimbursement and 340B Drugs: Riёtte van Laack and Alan M. Kirschenbaum’s post provides an overview of the court decision to enjoin CMS from implementing a regulation setting reimbursement for hospital outpatient payment rates for 340B drugs at Average Sales Price minus 22.5%. 
  • Laboratory Testing Facilities: Serra J. Schlanger describes in her post an overview of the Eliminating Kickback in the Recovery Act of 2018 (“EKRA”), particularly how laboratory testing facilities are impacted by the legislation, and describes similarities and distinctions between EKRA and the Federal Health Care Program Anti-Kickback Statute.


  • New Procedures and Forms: Larry K. Houck describes in his post the DEA’s proposal to implement new order forms and to expand who can issue powers of attorney authorizing employees to execute Official Order Forms (“DEA-222s”).


  • Hemp and Cannabidiol (“CBD”): Larry K. Houck and Ricardo Carvajal describe in their post the effects of the Agricultural Improvement Act of 2018 (“the Farm Bill”) on hemp, marijuana, and CBD, including the removal of “hemp” from the definition of marijuana as a controlled substance while also noting that FDA still restricts the use of hemp in food and dietary supplements.


Hyman, Phelps & McNamara has its finger on the pulse of FDA. As the largest dedicated FDA law firm in the United States, our technical expertise and industry knowledge are exceptionally wide and deep. Our professional team possesses extensive experience with the universe of issues faced by companies regulated by FDA. See our award-winning FDA Law Blog: http://www.fdalawblog.net/