Rik Mehta Condemns Menendez, Pascrell for Attempting to Influence FDA and Block Use of Hydroxychloroquine to Treat COVID-19 Patients

In a letter sent Monday, Republican U.S. Senate frontrunner and former United States Food and Drug official Dr. Rik Mehta, along with former Assistant Secretary of Health and retired 4-star Admiral Dr. Joxel Garcia, applauded the work of Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, and admonished a dangerous and irresponsible letter issued by Democrat Sen. Bob Menendez and Rep. Bill Pascrell in which they decried FDA for fast-tracking the review process for hydroxychloroquine and chloroquine under Emergency Use Authorization (EUA) while calling on Commissioner Hahn to halt the use of these potential treatment options for COVID-19 patients.

“Senator Menendez and Congressman Pascrell are letting partisan politics get in the way of science and it’s offensive.  This letter by Menendez and Pascrell will have a negative and chilling effect within the medical research community,” Rik Mehta said. “The medical research community is applauding the FDA’s concerted efforts to advance rapid drug development, devices and diagnostics through regulatory science. These ill-informed politicians are placing lives at risk. Science is only good when you have it. The job of the FDA Commissioner is not to stop work until science is available, but to make tough decisions when it’s not.”

Mehta further noted that “the hardest part of the FDA’s job is not making decisions based on science but making decisions in the absence of science.” He noted that “the laws allow the discretion of the FDA Commissioner to act broadly. And, as well, he should.”

In their purely partisan and severely misinformed letter, Menendez and Pascrell criticized the FDA for issuing an emergency approval of hydroxychloroquine and chloroquine to treat COVID-19 and complained that because there are shortages of these drugs for patients with autoimmune diseases like rheumatoid arthritis and lupus who require them as part of their treatment, dying coronavirus patients should be barred from having immediate access to them.

“The shortage of these drugs is nothing more than failed Obama-era policies that have allowed for globalization of our supply chain,” Mehta said. “Dr. Hahn should allow for exemptions in the Drug Master File to allow for new API sourcing and increase the availability of these drugs in the U.S. We shouldn’t have to pick between one disease state or the other. Nor should we rely on China for our source ingredients.”

Mehta, who served as a former FDA official in medical policy noted that “FDA must not suffer analysis paralysis during a pandemic”.  As the former Deputy Director of the DC Health Department, Mehta pushed to change state health laws that allowed for greater protections of the doctor-patient relationship to prescribe off-label in the absence of an FDA-approved indication when patients faced life-threatening conditions. “We have a similar situation for hydroxychloroquine and chloroquine. And, until robust clinical studies support that it does or does not work or there are additional safety concerns that preclude its use, we should allow for access for patients who need it and pivot towards retrospective studies to measure evidence of efficacy.” Mehta added, “There is no doubt that hydroxychloroquine and chloroquine should maintain fast-track status under an Emergency Use Authorization until a decision is made about its approvability for COVID-19. People are dying and they must have a right to try this life-saving drug.” The focus should not be on which disease state gets the drug, but how to bring our drug manufacturing back to America and quickly.