- The End of FDA's LDT Rule
- An Analysis of HHS Workforce Reductions Raises Concerns
- FDA Establishes "PreCheck" Program
- Status of the Make America Healthy Again (MAHA) Strategy Report
The End of FDA's LDT Rule
Earlier this month, the Office of Information and Regulatory Affairs (OIRA) updated its list of rules pending review under Executive Order 12866 to include FDA's request to rescind its controversial Laboratory Develop Test (LDT) rule. This action was expected following the decision by the Department of Justice (DOJ) not to appeal a ruling by the U.S. District Court for the Eastern District of Texas, which, as we previously discussed, vacated the rule on the grounds that the Federal Food, Drug, and Cosmetic Act does not grant FDA authority to regulate LDTs as medical devices. With the FDA's recission of the LDT rule, important questions remain unanswered about the future of LDT regulation. We examine these issues in detail here.
An Analysis of HHS Workforce Reductions Raises Concerns
Recently, ProPublica released a report detailing the significant workforce reductions at the Department of Health and Human Services (HHS), with more than 20,000 positions eliminated or vacated since the Trump administration began. According to ProPublica's analysis of the HHS employee directory, FDA has lost 21% of its overall staff. However, the impact of these losses has not been uniform across the Agency. For example, the Center for Drug Evaluation and Research and the Human Foods Program have each lost 20% of their staff, while the Center for Biologics Evaluation and Research has lost 26%. These reductions have affected scientists, investigators, and regulatory professionals, and could potentially impact the FDA's ability to perform its essential public health and regulatory functions.
FDA Establishes "PreCheck" Program
On August 7, FDA announced its new FDA PreCheck program, designed "to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States." As part of an effort to encourage the development of drug manufacturing facilities in America, the program consists of two phases: 1) the Facility Readiness Phase and 2) the Application Submission Phase. The Facility Readiness Phase offers manufacturers increased communication with FDA during key development stages (e.g., facility design, construction, and pre-production) and encourages submission of detailed facility-specific information via a Type V Drug Master File, which can be included by reference into a drug application. The Application Submission Phase streamlines the Chemistry, Manufacturing, and Controls section's development by providing early feedback and holding pre-application meetings. FDA will hold a public meeting on September 30, during which it will present the draft framework of the PreCheck program, and stakeholders can provide feedback and offer ideas to improve U.S. drug manufacturing.
Status of the Make America Healthy Again (MAHA) Strategy Report
This week, Politico reported on a "leaked draft strategy" of the much anticipated MAHA report, which was expected on August 12 but has not yet been released. The strategy outlines certain regulatory reforms, such as changes to FDA's GRAS process and infant formula requirements, but otherwise does not include the massive policy changes many had anticipated (e.g., stricter controls on pesticide use). We will provide additional updates once the final report is released.
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions about how the contents of this article may impact you or your business's interactions with the FDA, please contact the authors today.