FDA Blocking a New COVID-19 Treatment Because Clinical Trials Weren't American
A recent article in the New York Times details problems one pharma company is having getting approval for a new post-infection COVID-19 treatment. This post is your TL;DR for that article.
Existing monoclonal antibody treatments have lost effectiveness due to new variants, and the only option for universal treatment at this point is Paxlovid. However, Paxlovid has worrisome interactions with other drugs, meaning some people can't take it.
A company called Eiger Biopharmaceuticals developed and requested emergency use authorization from the FDA for a drug called pegylated interferon lambda. Interferons are proteins that signal to your immune system that there is an invader that needs to be eliminated.
Interferon drugs are tricky because they signal your immune system to attack, and most kinds have receptors throughout the body. However, the company found a type of interferon whose receptors are specific to the respiratory tract.
This means the drug could be useful in treating other respiratory viruses too, not just SARS-CoV-2. In a clinical trial the drug was as good as Paxlovid in warding off hospitalization when given within a week of infection, and worked even better when administered within three days.
However, the FDA declined to endorse the drug at this time because the clinical trials were done outside the US (in Canada and Brazil) and were done by academic researchers rather than the company. Starting new trials in the US and run by the company would take years and additional funding. As a result they are going to seek approval in other countries like China.
Not to tell FDA their business, but what is magical about a trial in the U.S. and done by the pharma company? People are people no matter what country they live in, and I actually trust academic researchers more than a commercial entity trying to promote a product.
Academics also produce detailed descriptions of their methods, like they did in this case. Why can't the FDA can't assess the quality of their methodology and use that as a basis for their decision?
This whole thing sounds to me like red tape and not-invented-here thinking. As the article notes:
These barriers are indicative of problems that some experts worry are threatening the development of a wide range of next-generation Covid treatments and vaccines — products that may help address the ongoing toll from Covid and also give scientists a head start in preparing for the next pandemic.
