Letter to Stephen Hahn, Commissioner of the Food and Drug Administration - We Need True Positives, True Negatives: Doggett and DeLauro Press FDA for Data on the Accuracy of COVID-19 Tests

Letter

Dear Commissioner Hahn:

In response to the coronavirus disease 2019 (COVID-19) pandemic, the Food and Drug
Administration (FDA) has acted to increase the availability of possible COVID-19 treatments,
diagnostic tests, and other medical products. We write to request information about how the
agency is tracking the usage, safety, and effectiveness of these products in order to protect and
ensure the health and safety of all Americans during the COVID-19 pandemic.

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the FDA Commissioner may issue
Emergency Use Authorizations (EUAs), which "allow unapproved medical products or
unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or
prevent serious or life-threatening diseases… when there are no adequate, approved, and
available alternatives."

Since February 4, 2020, the FDA has issued 112 EUAs for COVID-19-related medical products,
including tests, personal protective equipment, and ventilators.
This is an unprecedented expansion of EUAs--only 77 EUAs were issued between 2005 and 2018.3 The seriousness of
the COVID-19 pandemic indeed warrants extraordinary measures, but it also places on the FDA
the burden to track the usage of these newly-authorized products.

As the FDA rapidly expands access to COVID-19-related medical products, it must also track
these newly authorized products and uses to ensure that any benefits are not outweighed by
negative consequences and to inform the agency's future decisions. Federal law mandates that
the FDA require the monitoring and reporting of adverse events in certain products approved
through EUAs. For example, FDA required such monitoring and reporting in a March 28, 2020 EUA for chloroquine phosphate and hydroxychloroquine sulfate ("hydroxychloroquine"). It is critical that the FDA is able to track and analyze this data as efficiently and comprehensively as
possible to appropriately evaluate the safety and efficacy of products that are authorized under a
lower evidentiary standard than what would be imposed when evaluating the products under the
clearance or approval standards.

Concerns raised about the safety, efficacy, and quality of hydroxychloroquine for the treatment
of COVID-19 highlight how important it is for the FDA to track the health and safety outcomes
of products authorized via EUA. The FDA issued an EUA for hydroxychloroquine on March 28,
2020, not long after President Trump reportedly "contacted Dr. Stephen Hahn, the FDA
administrator, and other top health officials, questioning whether they were moving rapidly
enough to make the drugs more widely available."7 We are concerned that the EUA may been
issued despite known issues relating to safety, efficacy, and quality.8 There is limited evidence of
hydroxychloroquine's effectiveness in treating COVID-19, but well-known lethal cardiac side
effects. There are also reports that the FDA lowered its quality-control standards so that the
Administration could accept Bayer Pharmaceutical's donation of millions of hydroxychloroquine
tablets for distribution under the EUA, and could import hydroxychloroquine from Ipca
Laboratories, which had previously been cited by the FDA for manufacturing lapses.11 Finally, a
study of patients hospitalized with COVID-19 at U.S. Veterans Health Administration hospitals
found that there was no benefit to patients who took hydroxychloroquine to treat COVID-19,12
and the FDA has now cautioned against its widespread use.13 This information underscores the
critical importance of tracking and reporting the post-EUA safety, efficacy, and quality of
products authorized to fight COVID-19.

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, said on
April 29, 2020, that data from a trial testing the antiviral drug remdesivir was promising, and
said that it "will be the standard of care."14 On May 1, 2020, the FDA issued an EUA for
remdesivir to be used for the treatment of patients hospitalized with COVID-19.15 The EUA
requires that Gilead Sciences, the maker of remdesivir, as well as healthcare facilities and
providers receiving remdesivir, track serious adverse events and report them to the FDA.16
Healthcare facilities are also required to maintain records regarding the use of remdesivir that
must be made available to FDA for inspection upon request. Given that demand for remdesivir
will likely be extremely high, it is imperative that the FDA track and analyze all available data
and information associated with the administration of remdesivir under the EUA, including
reported adverse events, to ensure that remdesivir's benefits outweigh its risks. Furthermore, the
FDA must ensure that Gilead Sciences, and healthcare facilities and providers, report adverse
events and maintain records as required by the EUA.
In the face of this pandemic, the FDA has an important role enabling the rapid emergency use of
various drugs, biological products, and devices, including diagnostics, using data-driven,
science-based decision-making processes. We urge the FDA to track and analyze adverse events,
outcomes data, and product quality issues for products authorized under EUAs to ensure their
benefits outweigh their risks. We also request that you provide answers to the following
questions by May 20, 2020.
1. Please describe the systems and procedures that the FDA has in place for tracking
adverse events related to the wide array of COVID-19-related products that have been
authorized by EUAs.
a. Are the same systems and procedures in place for blanket EUAs? If not, how are
they different?
2. Please describe the systems and procedures that the FDA has in place for tracking
postmarket outcomes data and information on COVID-19-related medical products.
a. The EUA for hydroxychloroquine includes that "If and when HHS establishes a
process for collecting outcomes data [associated with the use of the authorized
chloroquine phosphate or hydroxychloroquine sulfate], HHS will inform public
health authorities about such process."
17 Has HHS established such a process
and/or informed the FDA of such process? Please share any communications or
documents regarding such a process.
3. Please describe the systems and procedures that the FDA has in place for tracking
product quality data and information related to COVID-19-related products that have
been authorized by EUAs.
4. Please provide a document describing, for each active COVID-19-related EUA, any
arrangement the FDA has with companies, healthcare facilities, providers, or other entities, to collect, monitor, and report adverse events, outcomes, and product quality data
and information, and whether any such arrangement is a condition of said EUA.
5. Please provide any documents or policies regarding how the FDA uses adverse events,
outcomes, and product quality data and information to inform future EUAs for COVID19-related medical products. What plans or processes has the FDA established for
revoking or amending EUAs, if necessary, based on this data?
6. What is FDA doing to ensure that companies, healthcare facilities, and providers are
appropriately collecting, monitoring, and reporting adverse events, outcomes, and
product quality data and information? What actions, if any, is FDA prepared to take if
these entities are not collecting, monitoring, or reporting this data and information?
7. Has the COVID-19 pandemic exposed shortcomings in the FDA's authorities and
abilities to obtain and use postmarket data and information that should be addressed by
legislative action? Does FDA have sufficient authority to revoke EUAs and recall
medical products subject to those EUAs if necessary?
Sincerely,

Source