Letter to Robert Kadlec, Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services and Gary Disbrow, Acting Director of the Biomedical Advanced Research and Development Authority - Pascrell and Menendez Sound New Alarms in COVID Drug Politicization
Letter
Dear Assistant Secretary Kadlec and Acting Director Disbrow,
We write today to request information about the status of the development of COVID-19 vaccines
and therapeutics supported by the federal government. We recognize and appreciate the need for
expediency during the ongoing pandemic to provide a vaccine that will allow Americans to return
to some semblance of normalcy. However, such expediency must not abandon the core principles
of safety, efficacy, and transparency that should be the cornerstones of our collective national
efforts on development of COVID-19 vaccines, treatments, and diagnostics. Any decisions
regarding the development of vaccines and therapeutics should be based on sound science only,
not political pressure or favoritism. To that end, we request information about the Administration's
work on advancing therapeutics and diagnostics for COVID-19.
We previously wrote to the Department of Health and Human Services Office of the Inspector
General about the Food and Drug Administration's (FDA's) April 27, 2020 Emergency Use
Authorization (EUA) for hydroxychloroquine and chloroquine and the role played by Dr. Rick
Bright, who was removed from his position as Director of the Biomedical Advanced Research and
Development Authority (BARDA). The EUA led to confusion about the drugs' efficacy in treating
COVID-19. Subsequently, on June 15, 2020, the FDA withdrew their EUA for these two products,
but real and irreversible harm was done because of the FDA's rushed rubber stamp approval. The
United States is currently in possession of 60 million unused doses of hydroxychloroquine as a
result and the damage to the FDA's reputation as the gold standard for drug approvals remains.
Since Dr. Bright's departure, BARDA's work appears to have changed significantly. On June 3,
2020, BARDA amended the Broad Agency Announcement (BAA), originally released on March
4, 2020, to suspend Areas of Interest that are integral to the development of therapeutics to prevent
and to treat COVID-19. Instead of working with partners to develop products to diagnose, treat,
and prevent COVID-19, BARDA has decided to focus efforts mainly on vaccines and therapeutics
that do not treat the full range of the disease. BARDA's wholesale shift in strategy occurred
without notice to its partners. The lack of transparency in the move, including shifting resources
away from BARDA's core mission, is extremely shortsighted.
We request responses to the questions below no later than July 20, 2020 and would also request a
Congressional briefing on these issues:
1. How much funding has been allocated to the development of new therapeutics that have
shown evidence to improve symptoms in patients with COVID-19?
2. Why were Areas of Interest 9.3: Immunomodulators or therapeutics targeting lung repair;
9.5: Pre-exposure and Post-exposure Prophylaxis; and 11: Ventilators suspended in the
amended June 3 BAA? Who made the decision to suspend those Areas of Interest?
3. How many companies were removed from BARDA's process or had contracts cancelled
by BARDA after the amended June 3 BAA?
4. HHS made a statement that BARDA is "only leaving open areas of interest that are of
highest priority" in order to "make the most of potential partners' time and effort." Why
did BARDA open Areas of Interest 1 through 6, which are unrelated to COVID-19, in the
amended June 3 BAA?
5. How does BARDA's operation function with the President's "Operation Warp Speed" and
the National Institutes of Health's Accelerating Covid-19 Therapeutic Interventions and
Vaccines (ACTIV) project?
6. Has any funding been diverted from BARDA to "Operation Warp Speed"?
Thank you for your consideration of this critical issue. We look forward to hearing from you and
working with you going forward on this important issue.
Sincerely,
Source