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Biden administration faces key decisions on drug testing and access amid vaccine distribution challenges.
The new year began with a continued surge in illness and deaths due to COVID-19, along with high hopes for combatting the virus with effective vaccines and therapies. Strong efficacy data and reassuring safety reports indicate that new vaccines may prevent contamination, thus shifting the focus to the monumental task of producing, packaging, shipping, and administering millions of doses as quickly and effectively as possible. The success of biopharmaceutical manufacturers in developing and testing a whole new type of vaccine in less than a year reflects the scientific and technological strength of the industry and the research community, bolstered by critical financial and regulatory support from governments and international organizations.
Public health officials face significant challenges in effectively delivering vaccines to priority populations, particularly those preventives requiring two doses and ultra-cold shipping and storage. The new products are targeted first to healthcare workers and nursing homes, with distribution assigned to state and local health departments that desperately seek additional federal support for identifying priority populations, transporting appropriate doses safely, and tracking these operations effectively.
With limited access to COVID-19 vaccines for months ahead, researchers and manufacturers will continue to test hundreds of new and existing therapies for potential in treating infected individuals. FDA has authorized emergency use for a few monoclonal antibodies and antivirals found slightly effective against the virus, and investigators are testing further dozens of antimalarials, immunosuppressants, and other compounds.
FDA’s ability to assess and communicate appropriate use of new coronovirus vaccines and therapies will be critical for the agency to regain public trust and confidence in its expertise and the products it approves. It is vital for new leadership to navigate carefully between promoting public access to potentially life-saving treatments and limiting expectations for unproven therapies, despite outside political pressures.
In addition to dealing with the pandemic, FDA will continue efforts to move a broad range of promising new drugs to market through guidance development, accelerated approval initiatives, and efficient review and approval programs for drugs, generic drugs, biologics, and other medicines. The agency has seen a surge in R&D on new cellular and gene therapies, and more new biosimilars promise to facilitate access to important biotech therapies. At the same time, FDA is negotiating new agreements with industry to update user fee programs for drugs, biologics, generic drugs, and biosimilars, which need to be sent to Congress by the end of the year in order to be renewed by Oct. 1, 2022, when current fee programs expire.
Despite industry’s success in developing new COVID-19 therapies and vaccines, policymakers on all sides will continue to raise questions about pricing and access to vital treatments in the US and around the world. There is bipartisan support for a range of drug price control measures, including versions of the Trump administration’s reference pricing and rebate reform initiatives. Some states also are pressing for wider import of less costly drugs from Canada, despite safety concerns for such activities, as well as objections from Canadian health authorities. Pharma leaders insist that too-harsh price regulation will limit the broad innovation and drug development that has been critical for combatting the pandemic, but will face continued pressure to moderate prices for both new and existing medicines.
FDA enforcement activities also face changes following a halt in most field inspections of drug facilities due to the pandemic. While there’s pressure to resume more onsite visits to better assess the quality of promising new therapies, the agency will continue to rely more on alternative sources of information on the regulatory standing of operations. The pandemic also has highlighted global supply chain vulnerabilities and the importance of more reliable and flexible manufacturing processes for drugs and vaccines. Policymakers want strategies to better anticipate and resolve supply shortages, which may involve efforts to boost drug manufacturing in the US.
The new administration will also need to address broader economic relief and public health measures as the pandemic continues. The Biden team has mapped out a broad health policy agenda that includes retaining Affordable Care Act (ACA) provisions for healthcare coverage in the face of further Supreme Court deliberations on that issue.
Jill Wechsler is Pharm Exec’s Washington Correspondent. She can be reached at firstname.lastname@example.org.