By Larry K. Houck — Scheduling Criteria Under the Controlled Substances Act (“CSA”) Schedule I:• High potential for abuse; • No currently accepted medical use in treatment in the U.S.; and • Lack of accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1). Schedule III:• Potential for abuse less than drugs or substances in schedules I and II;• Currently accepted medical use in treatment in the U.S.; and • Abuse may lead to moderate or low physical dependence or high psychological dependence.  Id. § 812(b)(3). **** Last October President Joe Biden asked the Secretary ..read more

By Larry K. Houck — Last October, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing current marijuana scheduling under federal law.  Then, Congress passed and the President signed the Medical Marijuana and Cannabidiol Research Expansion Act into law in December.  Last month, the Food and Drug Administration (“FDA”) announced in a release that it would not conduct rulemaking that would allow cannabidiol (“CBD”) to be marketed in dietary supplements or conventional foods because “a n ..read more

By Larry K. Houck — At least one public interest group and several members of Congress remain frustrated with the Biden Administration’s failure to take action to legalize cannabis.  Within the last month, the Cannabis Regulators of Color Coalition (“CRCC”) and handful of Democratic Senators have separately reached out to Biden Administration officials, including Attorney General Merrick Garland, requesting action to mitigate or eliminate federal prohibition on the use of cannabis. As a reminder, cannabis remains a schedule I substance under the federal Controlled Substances Act (“CSA ..read more

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — Closed-loop control systems, which adjust device output based on information received from a sensor to keep a variable at a reference position, are common in many medical devices.  There are numerous examples where device output is controlled to maintain a physical measurement, such as pressure, at a set point.  When the variable of interest is a physiologic measurement, the patient becomes part of the closed-loop control system and clinician involvement in responding to changes in the patient’s condition can be reduce ..read more

By McKenzie E. Cato — On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing.  In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.”  In May 2016, FDA released a draft ..read more

By Sara W. Koblitz — Since the August 2021 decision in GSK v. Teva, the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive.  With the District Court of Delaware’s January 4 decision in a similar case (brought by GSK’s lawyers), Amarin v. Hikma, the generic industry can have some hope.  Relying heavily on the Federal Circuit’s contention that the decision in GSK v. Teva was a “narrow, case-specific review,” Judge Andrews dismissed Amarin’s suit against Hikma in which Amarin alleged that Hik ..read more

Hyman, Phelps & McNamara, P.C. is the largest dedicated FDA law firm, and we need attorneys to help our clients bring pharmaceutical drugs and medical devices to market.  Our ideal candidates have experience working at FDA (CDER, CDRH, CBER, or OCC), or have at least two years working in private practice with a sophisticated FDA practice group.  Our firm culture is collaborative, the work environment is flexible, and the subject matter is intellectually stimulating.   If you want to join our team, please send your resume to Anne Walsh, awalsh@hpm.com.     ..read more

By Michael S. Heesters & Jeffrey N. Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018.  EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here.  Until recently, no federal court had had occasion to interpret EKRA.  That changed on October 18, 2021 when the Federal District Court for the District of Hawaii handed down a decision that construed key terms in the statute. I.   The E ..read more

Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director.  Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the Orphan Drug Act, biosimilars, and the Orange Book.  She assists pharmaceutical drug companies of all sizes on product lifecycle management, as well as regulatory strategies related to obtaining FDA approval, exclusivity, and patent listing.  Sara also has been hea ..read more

Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce Adrienne R. Lenz has become its first Principal Medical Device Regulation Expert.  Adrienne joined HPM in September 2017.  In her time with HPM, she has made significant contributions to the firm and its clients. Prior to joining HP&M, Adrienne worked as an independent regulatory consultant and consultant with Emergo.  She has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical. As a Principal Medical Device Regulation Expert, Adrienne ..read more