These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love. During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert. This is the fifth 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.
- Impact on Clinical Trials: James Valentine, Dave Clissold, and Jeff Shapiro discuss FDA’s Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 that addresses the unprecedented set of challenges that make conducting clinical trials difficult during a pandemic. In a second post, the trio describes FDA’s update to the Guidance, which provides 10 responses to commonly asked questions. This Q&A portion addresses two of the largest decisions sponsors must make as a result of this pandemic: (1) whether to continue the study and (2) whether to continue administering the investigational product. Other Q&A’s address managing protocol deviations and amendments, helping navigate a number of contingency measures (e.g., initiating virtual visits, switching to home delivery or infusion of the investigational product, alternative monitoring), and documenting informed consent from a patient in isolation.
- State Regulations: Kalie Richardson describes in these posts (here and here) how certain states have issued COVID-19-related waivers or suspensions affecting pharmacy staffing, facility licensure, and controlled substances distribution and inventory. These waivers meet the dual objectives of enhancing pharmacy response to the ongoing COVID-19 pandemic while also allowing pharmacy staff to responsibly practice social distancing.
- Postmarketing Reporting: Anne Walsh discusses FDA’s initiative to alleviate companies’ postmarketing reporting obligations for their routine, non-COVID-19-related products during a pandemic. Recognizing that a pandemic can result in a shortage of FDA and industry resources and staff, FDA will exercise enforcement discretion for delayed reporting of certain required adverse events reports, with the expectation that such reports will be submitted within 6 months when operations resume to pre-pandemic levels. Walsh’s key takeaways are for companies to document any inability to meet their obligations to submit postmarket reports and to develop a robust Continuity of Operations Plan to make seamless their decision-making should (heaven forfend) another pandemic occur.
- Compounding: In this post, Karla Palmer discusses FDA’s temporary guidance addressing the unprecedented disruptions to the supply chain caused by COVID-19 that permits the compounding of certain drug products for hospitalized patients by outsourcing facilities that have registered with FDA under FDCA § 503B. Palmer discusses the 4 criteria outsourcing facilities must meet in order to avoid FDA action for compounding a drug product that is essentially a copy of an FDA-approved drug, for using a bulk substance not on FDA’s 503B Bulks List, or for not meeting cGMP requirements. In a follow-up post, Palmer describes a second FDA guidance to address drug shortages during the pandemic. This unprecedented policy allows 503A compounders to compound certain identified shortage medications for patients in hospitals without a prescription for an individually identified patient and essentially permits compounding for “office use.”
- Healthcare: In this post, Faraz Siddiqui, Michelle Butler, and Alan Kirschenbaum describe a recent court decision out of the D.C. District Court that construed the term “original new drug application” in a manner that may offer rebate relief to companies marketing drugs approved under FDA’s pre-Hatch-Waxman paper NDA policy as well as those approved under literature-based applications submitted under FDCA § 505(b)(2).
- Devices: Jeff Gibbs, Gail Javitt, and McKenzie Cato discuss FDA’s new approach to regulating pharmacogenomic (PGx) tests in this post. FDA acknowledged that PGx tests could play a useful role in informing the selection or dosing of some medications for certain individuals and specifically recognized that gene-drug interactions could be adequately supported by professional guidelines, which is a step forward and a change from FDA’s prior communications.
- Cannabis: In this post, Larry Houck describes DEA’s March 23rd Notice of Proposed Rulemaking (NPR) that would permit the issuance of additional registrations to manufacture marijuana for research and, notably, allow the agency to insert itself in the manufacturer-to-researcher equation by buying, taking possession of, and directing marijuana to researchers. Houck discusses the NPR, subsequent U.S. obligations under the Single Convention on Narcotic Drugs of 1961, and possible implications of DEA being an active player in the marijuana enterprise.
In this post, Kalie Richardson describes the state regulatory landscape as it pertains to telemedicine and medical marijuana. Several states, including Minnesota, Massachusetts, Ohio, and the District of Columbia, have issued policies waiving the requirement that patient certification be made only during an in-patient visit to be eligible for the state medical marijuana program. Additionally, some states have deemed medical cannabis licensees as essential businesses that may remain open.
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