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Areas of focus during phase-out include telehealth and patient access.
The termination of the public health emergency (PHE) declared three years ago will end various subsidies and flexibilities for healthcare services and treatments. The change, however, will have a less immediate effect on FDA policies governing the approval and marketing of drugs and medical products, as the agency’s authority to use emergency use authorizations (EUAs) for vaccines, diagnostic tests, and therapies will remain in place and are not tied directly to the government’s PHE declaration of March 2020.
Even so, FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by EUAs, as there is some uncertainty about how long many quick approvals of drugs and biological products will remain in effect. Manufacturers of the leading vaccines and medical products approved under the EUA process have conducted additional studies to provide data to the agency to gain fully approved licenses and applications. But the largest number of such fast authorizations are for some 400 COVID-19 tests and diagnostics, and manufacturers of many of these products are expected to end production as demand drops.
Biopharma companies also are watching how the health emergency phase-out affects telehealth services and patient access to care, where more flexible pandemic policies permitted providers to prescribe certain medicines via remote visits, including controlled substances. FDA may retain certain flexibilities for developing generic drugs, meeting certain post-marketing requirements, and holding virtual meetings with sponsors to discuss development programs or manufacturing issues. And sponsors of clinical trials may continue to benefit from modifications in clinical research requirements, such as more leeway to conduct informed consent and to track responses and health changes of study participants via remote access methods.
One area of change, though, is the status of multiple FDA guidances published during the health emergency without the usual lengthy comment-and-finalization process. FDA posted a notice on March 13 addressing which of more than 70 guidance documents issued during the pandemic would be revised and retained, and which will expire with the declared end of the PHE.
Many of these issues will be discussed and analyzed in the coming months as Congress works to reauthorize the Pandemic and All Hazards Preparedness Act (PAHPA), which governs emergency health programs but expires Sept. 30. The program supports medical countermeasure development and deployment, including the strategic national stockpile, Project BioShield, activities of the Biomedical Advanced Research and Development Authority (BARDA), EUAs, and other activities designed to better coordinate and prepare for PHEs. While there is bipartisan support for continuing PAHPA funding and programs, the reauthorization process will provide a forum for discussing both curbs and benefits of public health flexibilities.
These important regulatory issues may pale in comparison to the broader and more visible challenge to the biomedical regulatory process related to FDA’s approval of the abortion drug mifepristone more than 20 years ago. The Supreme Court recently put a temporary hold on a ruling by a federal judge that would limit access to the drug, but the situation still threatens to seriously erode the agency’s legal authority to evaluate the safety and efficacy of new drugs and medical products.
To prevent such an outcome, the Biden administration and mifepristone producer Danco Laboratories appealed the case to the Supreme Court. Generics maker GenBioPro also challenged the lower court ruling, as did multiple parties that filed amicus briefs, including members of Congress, physicians, abortion rights groups, and opponents. Pharma and biotech companies railed against this “unprecedented assault on FDA’s approval decisions,” predicting that such challenges could open the door to unfounded charges against all kinds of medicines and treatments.
In sending the case back to the appeals court, which set the rehearing for May 17, the high court temporarily retained patient access to mifepristone. But the charge that FDA ignored safety concerns and relied on “unsound reasoning and studies” to approve mifepristone for chemical abortions raises questions about whether other FDA decisions can be overturned by private parties opposing medical treatments that raise social, cultural, or economic issues. All parties expect the Supreme Court to have the final say on these important questions, probably later this year.