Letter to Hon. Janet Woodcock M.D., Acting Commissioner Food and Drug Administration - Long-term effects of Covid-19 infection

Letter

Dear Acting Commissioner Woodcock:

As we continue to battle the COVID-19 pandemic, it is clear there will be a lasting
impact on patients around the world. While many individuals who contract
COVID-19 are able to recover, there is a growing number who suffer long-term
symptoms. In addition to studying these long-hauler patients with continuous
symptoms, we must learn more about other potential long-term impacts of
COVID-19. Studies have shown coronavirus links to heart disease, lung damage,
and diabetes to name a few. The long-term impact for individuals of all ages
following COVID-19 is also unknown. We therefore ask that you update Congress
on FDA-NIH collaboration to study the impacts of the virus and your agency's
participation in the COVID-19 Diagnostics Evidence Accelerator.

Consistent with some of the provisions in the Ensuring Understanding of COVID19 to Protect Public Health Act (S.176), we are encouraged to see the National
Institutes of Health utilizing funds to support research focused on the prolonged
consequences of COVID-19 and how best to treat them. We also note that
Congress provided funding to the Food and Drug Administration (FDA) to
evaluate vaccines, therapeutics, and diagnostics to address COVID-19, and that
your agency has a key role in the design and implementation of studies to support
safe and effective treatments. This is critical not only for acutely ill patients, but
also for those suffering from long-haul COVID-19, as well as those with long-term
impacts that may have yet to surface. Ensuring that a diverse population is
included in these studies is also vital to understanding how this virus and possible
treatments impact people in different ways.

We request that you provide Congress an update on how FDA and NIH are
collaborating to ensure adequate data is available for regulatory decision-making
purposes, including identification of existing gaps and any future plans to fill in
those gaps. We also request an update on the collaboration announced last year
regarding FDA's participation in the COVID-19 Diagnostics Evidence
Accelerator, organized by the Reagan-Udall Foundation for the FDA and Friends
of Cancer Research, including how FDA is utilizing appropriated funds in recent
months to support this work. Public-private partnerships have been key to fighting
this pandemic and will continue to play a significant role in our recovery.