Why Did UK Regulators Beat The FDA To Approving Pfizer’s COVID Vaccine?

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From vaping to cutting-edge biotechnology, UK health regulators do a far better job than their American counterparts. This was proven yet again when the UK beat the U.S. FDA at approving a coronavirus vaccine produced by Pfizer, an American company.

The United Kingdom just became the first Western nation to approve a coronavirus vaccine for public use.

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While this is obviously excellent news, it’s also a bit puzzling: How is it that UK health regulators beat the U.S. FDA at approving a vaccine produced by Pfizer, an American company? The UK approved the vaccine on December 2nd, but the FDA isn’t expected to act until December 10th.

There are two possible explanations: (1) British health regulators have lower approval standards than American health regulators; or (2) British health regulators are more efficient, more evidence-driven, less risk-averse, and less political and ideological than American regulators. From what I’ve seen, the answer is #2.

Consider three examples that I discussed previously. First, UK regulators and public health officials acknowledge that smokers would be better off switching to vaping, while U.S. health officials seem to believe that vaping is just as big a public health threat as smoking. Science and common sense are on the side of the Brits. Second, the UK approved a biomedical technique, colloquially known as “three-parent embryos,” to help women with mitochondrial disease bear healthy children. Thanks to Congress, this procedure is still illegal in the U.S., even though healthy babies have been born using it since 2016. Third, UK health authorities have no problem calling out health scam artists like Gwyneth Paltrow, while U.S. regulators routinely ignore “health products” that are useless at best and dangerous at worst.

Taken together, it’s difficult to conclude anything other than British regulators are better at their jobs than their American counterparts.

Operation Reciprocity

There is one major policy change that could help fix this, and it has been endorsed by Dr. Henry Miller, the founding director of the FDA’s Office of Biotechnology: Reciprocity of approval. Under this policy, the FDA would automatically accept approvals from trusted foreign counterparts, such as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).

Implementing this policy would solve a lot of problems, first and foremost preventing shortages of vital drugs (including generic ones) that are faced by healthcare providers across the country, a problem that existed even before the COVID pandemic. It would also eliminate the need for a company like Pfizer to seek approval from multiple Western countries (if all of them adopted a reciprocity policy). This would allow life-saving treatments to be shipped sooner rather than later, the benefits of which are crystal clear in the time-sensitive crisis in which we find ourselves.

Reciprocity is not a cure-all for what plagues the American bureaucracy. But it certainly would prevent embarrassments like a foreign government approving an American product before the U.S. government gets around to it.

*Credit: American Council of Science and Health.

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