Eli Lilly Plant Set To Manufacture Covid-19 Therapy Cited For Breaching FDA Regulations

(Posted on Tuesday, October 20, 2020)

An Eli Lilly pharmaceutical plant set to manufacture a Covid-19 treatment has been cited by the Food and Drug Administration (FDA) for quality control issues, according to Reuters. Sources close to the situation told Reuters that Eli Lilly had falsified records pertaining to FDA manufacturing standards.

The Covid-19 treatment Eli Lilly is set to produce is an antibody therapy similar to a Regeneron therapy taken by the president during his infection. The President has called for the authorization of both treatments immediately.

The discovery of falsified records stems from a November inspection of the Eli Lilly plant. Following the inspection, the FDA granted the plant an “Official Action Indicated” notice, which means that “the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed” noted Patricia Zettler, a law professor at Ohio State University and former FDA official.

This report confirms our concerns from the start with fast-tracked Covid-19 therapies: beware of lower safety standards. Undue speed compromises manufacturing and distribution as well as efficacy and safety. Fast-tracked Covid-19 treatments already present health risks because nobody knows the long-term dangers of quickly approved and unstudied drugs and vaccines. Some health effects may occur over a period of many months to a year or more and cannot be evaluated in accelerated trials. The chance that undue speed may compromise safety is real, as the Lilly citation underscores.

Under normal circumstances, the FDA requires several batches of drugs to be made, all meeting the same safety, consistency, stability, and potency standards using the same facilities used to eventually sell the drug. This safeguard was discarded in the rush to move drugs and vaccines to market, imperiling patients.

We have seen EUAs for “miracle drugs” before after being highly touted by the administration. The EUA for hydroxychloroquine released in March was quickly revoked a few months later. The authorization letter cited only a limited French study of thirty-six participants. Despite only minimal evidence, the drug was allowed to proceed. After just three months, there was little evidence suggesting the drug effectively reduced Covid-19 symptoms, even provoking heart risks in some users, and was promptly revoked of its authorization status.

The dangers of premature EUA are two-fold. The first is the health dangers of approving a drug that does not work. Fast-tracked drugs and vaccines are at risk of harming participants in drug trials in the short term or the greater population in the long term. There have already been pauses in vaccine and drug trials due to patient development of severe unknown illnesses.

The second is the assurance that drugs will be safely and consistently produced. Production standards for drugs and vaccines are in place ultimately to protect the well-being of the nation. Someone hospitalized with severe Covid-19 symptoms is not concerned with the safety standards of some production plant. If their doctor tells them about an EUA approved drug, they will want it. It is the responsibility of the FDA to ensure that standards are being adhered to in order to protect those most at risk.

The issues with drugs tested in the US raises the question of the potential safety and efficacy of vaccines approved in both China and Russia. Might they have similar undisclosed issues? Both of the vaccines on pause in the US are broadly similar to those approved in China and Russia. We know little to nothing of the quality and safety standards applied. There are reports that the Chinese vaccine has been given to “hundreds of thousands” and that the Russian vaccine is also widely administered. The recent clinical development pauses of two Covid-19 vaccines in the US are currently paused as is the trial of the Lilly monoclonal antibody therapy, data on the safety and efficacy of the Russian and Chinese trials are overdue.

Covid-19 treatments have the potential to save thousands of lives as the United States approaches 220,000 deaths from the disease. To ensure a drug is successful, however, there must be regulations in place. The short-term protection from Covid-19 does not outweigh the long-term side effects of a defective drug. I hope that Eli Lilly is an aberration, not a trend

Read the article on Forbes. 

Originally published on October 30, 2020.