By Dan Levine and Marisa Taylor
Oct 13 (Reuters) – US drug inspection authorities discovered serious quality control problems at an Eli Lilly and Co pharmaceutical plant that is accelerating its work on developing one of two promising COVID-19 drugs touted by President Donald Trump as “a cure” for the disease, according to official documents and three sources familiar with the process.
Lilly’s antibody therapy, which is experimental and whose safety and efficacy has yet to be validated by regulators, is similar to a Regeneron Pharmaceuticals drug that was supplied to the US president during his convalescence from COVID-19.
Trump, who credits Regeneron’s drug for speeding up his recovery, has called for both treatments to be immediately available in an emergency, raising the expectations of some scientists and health policy experts that the US administration will publicly publish An Emergency Use Authorization (EUA) for the drug is imminent.
Advances in these drugs are key to the president’s efforts to convince voters that he has an answer to a pandemic that has already killed more than 215,000 Americans.
However, the findings of US Food and Drug Administration inspectors at the Lilly plant, which have not been previously disclosed, could complicate a US drug maker’s application, two of the sources told Reuters. two external legal experts. That’s because US law generally requires compliance with manufacturing standards for the authorization of a drug.
All three sources who spoke to Reuters asked to remain anonymous so they could speak freely without fear of retaliation.
Inspectors who visited the Lilly plant in Branchburg, NJ, last November found that data on the plant’s various manufacturing processes had been erased and not properly audited, official inspection documents show.
“The incidents eliminated and the consequent audit records were not reviewed by the quality unit,” the FDA inspectors wrote. Because the state inspection documents consulted by Reuters were drawn primarily by the FDA, it was not possible to learn more specific details of the inspectors’ findings.
Following its November inspection, the FDA classified the problems found as constituting a violation of the highest severity, resulting in an “Official Recommended Action” (OAI) notice.
This “means that the violations are serious enough and have a significant impact on public health that changes need to be made,” said Patricia Zettler, former FDA associate chief attorney who now serves as a law professor at State University. from Ohio.
Lilly announced Tuesday that it had suspended its clinical trial of its inpatient anti-COVID drug “due to excessive caution” in the face of a potential safety issue. The company did not disclose information on what the problem was and did not want to specify how the news could affect its request for a USA.
In response to questions from Reuters sent Monday about problems in the manufacturing process, Lilly confirmed the OAI notice but declined to give details about what led to the FDA intervention. The pharmaceutical company said it has put in place a “comprehensive repair plan”, has increased staff at the plant and is working “conscientiously” to address all the problems identified by the inspection.
The data suppressions noted by the FDA are not related to drug production, Lilly said.
“These findings do not affect product quality or patient safety, as described in a detailed evaluation submitted to the FDA,” the company said in its statement. “Lilly continues to provide updates to the FDA on progress toward finalizing our plan.”
The drug manufacturer declined to provide a copy of the information supplied to the FDA.
The FDA did not respond to requests for comment from Reuters. The White House declined to comment.
(Reported by Marisa Taylor from Washington DC and Dan LKevine from San Francisco; edited by Michele Gershberg and Julie Marquis; translated by Darío Fernández at the Gdansk newsroom)