FDA needs regulatory review and revamp

It’s not easy to ask federal agencies to regulate … themselves. Despite previously committing to a review of virtually all Food and Drug Administration (FDA) regulations, the Department of Health and Human Services (HHS) – the FDA’s parent agency – is backtracking on this commitment. HHS is postponing the comprehensive review by one year, claiming that undertaking the review now would divert critical resources away from the FDA’s response to the coronavirus pandemic.

The reality is, though, that the FDA’s overly broad regulatory agenda is compromising the evaluation process for vaccines and at-home testing. Unless the agency takes a long, hard look at its current guidelines, millions of people will continue to needlessly suffer. Now’s the time for regulatory review to make the FDA more efficient and responsive to the needs of Americans, instead of kicking the can down the road.

Under the previous “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) proposed rule published by HHS on Nov. 4, 2020, agency regulations already on the books are set to automatically expire 10 years after the regulation’s promulgation. If HHS, or its agencies (e.g. FDA), agree to review the expiring rule and find the rule worth keeping, the 10-year “shot clock” would start over. This framework ensures a timely spring cleaning of regulations that have long outlived their usefulness and are imposing substantial costs onto consumers and taxpayers. Delaying SUNSET standards by a year sets a terrible precedent by allowing the federal government to use the pandemic as an excuse to defer accountability. While a wide-ranging regulatory review would require additional manpower and resources, the regulatory status-quo is far more costly to the COVID-19 mitigation effort.

FDA regulations that once seemed urgent now serve as costly inconveniences to businesses and their consumers already trying to navigate complex coronavirus restrictions. For example, bioterrorism rules promulgated in the aftermath of 9/11 introduced strict controls on food and animal feed being imported into the country. One FDA rule imposed time-consuming advance documentation and notification of food products entering the country. Even if detailed information on the products is provided to the FDA upon the products’ arrival into the U.S., this would be considered inadequate and the products could be refused entry. While it’s unclear how these regulations would help prevent a terrorist attack, the compliance burden is certainly clear to shippers, manufacturers, and the FDA bureaucrats required to oversee this system. These hours could be better spent disinfecting facilities and evaluating COVID-19 tests and vaccines. But instead, hundreds of FDA rules from a bygone era clog the system and prevent all parties from fully focusing on the pandemic.

And, the stakes are far larger than post-9/11 reporting requirements. According to a 2019 study by MIT researchers, FDA statistical standards are far too strict for medications geared toward severe diseases such as pancreatic cancer. Even if a promising medication could save the life of a seemingly terminal patient, the agency doesn’t want the negative publicity of something negative happening after an ill-advised approval. George Mason University scholar Alex Tabarrok notes, “the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case, at least some victims are identifiable, and The New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.”

Without a significant push, the FDA will continue to have a slow, risk-averse approval process that results in the greenlighting of far-too-few vaccines and at-home tests. The agency refuses to approve the AstraZeneca vaccine, despite recent data showing that the vaccine is roughly 70 percent effective in preventing COVID-19 symptoms (and even more encouraging data from the U.K. rollout). A comprehensive review of FDA regulations could go a long way toward changing how the agency evaluates its products. Millions of lives hang in the balance.

This article was originally posted on FDA needs regulatory review and revamp

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