By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.  The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). Once finalized, the content from the draft guidance will be included within the existing cybersecurity premarket guidan ..read more

By Larry K. Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III.  US poised to ease restrictions on marijuana in historic shift, but it’ll remain controlled substance (Apr. 30, 2024).  Xochitl Hinosa, Justice Department Director of Public Affairs, confirmed that Attorney General Merrick Garland signed off on DEA’s proposal stating, “Today, the Attorney General circulated a pr ..read more

By Jeffrey N. Gibbs & Allyson B. Mullen — On April 29, 2024, FDA announced its finalization of the laboratory developed test (LDT) rule.  The final rule will be published in the Federal Register on Monday May 6, 2024 (here).  The final rule marks another milestone in the more than three decades long battle over LDTs.  FDA notes that it received over 6,500 comments on the proposed rule.  Showing how motivated FDA was to quickly finalize the rule, the Agency claims to have reviewed and addressed all major issues they raised in less than 5 months. As regular readers of the ..read more

Hyman, Phelps & McNamara, P.C. proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Her expertise spans a range of critical areas including: human subject protections, clinical trial conduct, development strategies, FDA interactions, and enforcement action responses. “Sarah’s a tremendous attorney who always understood HPM’s culture and commitment to clien ..read more

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, which included some changes over the existing guidance which could have a negative impact on future pre-submissions. The draft guidance attempted to clarify when a Sponsor’s question may be more appropriate for more informal communication.  The guidance recommends that questions “that can be readily answered” based on the FDA reviewers “experience or knowledge” and that “do not require additiona ..read more

By Larry K. Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. treaty obligations under the Single Convention, 1961, when rescheduling marijuana.  Later Democratic lawmakers, eleven senators and ten members of Congress, also penned a letter to Administrator Milgram and Attorney General Merrick Garland imploring DEA to not only “promptly remove marijuana” from schedule I of the Controlled Substances Act (“CSA”), but to deschedule it altogether ..read more

By Sarah Wicks & Dara Katcher Levy — On April 24, 2024, the FDA issued a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers, (the “Revised Draft Guidance”) which replaces the Agency’s initial draft guidance issued in February 2020 (the “Initial Draft Guidance”). This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar produ ..read more

By Allyson B. Mullen & Jeffrey N. Gibbs — We’ve been hearing for quite some time that a Final LDT Rule would likely be coming this spring, before May 1.  This timing has been attributed to FDA’s desire to avoid having the rule being overturned by Congress under the Congressional Review Act.  Of course, if a new administration takes over next year, the rule’s future would be questionable, even without congressional action. As of Monday, April 22, FDA appears to be one step closer to achieving that timing goal with Office of Management and Budget (OMB) having completed its review o ..read more

By Larry K. Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August.  We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for reschedulin ..read more

By Kurt R. Karst — If you’ve been following this blog since the early days, then you know we fervently followed the more-than-decade-long soap opera that was The Medicines Company’s efforts to obtain a Patent Term Extension (“PTE”) from the U.S. Patent and Trademark Office (“PTO”) for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) after the company’s patent counsel untimely filed for a PTE 62 days after the ANGIOMAX NDA 020873 approval at 5:18 PM on Friday, December 15, 2000 (see our summary and “coda” posts here and here).  The way that matter ended up—after touching all three ..read more