The standard example generally given to justify the FDA’s rules is Thalidomide, which resulted in thousands of babies being born with deformed limbs because their mothers used it during pregnancy. Hailed as a wonder drug that treated insomnia, mild depression, and morning sickness, it was available in most of Europe but had not been approved for use in America. The advantage of strict FDA rules is obvious, given this example.

The main disadvantage is the massive barrier to market entry presented by FDA rules. Drugs can take billions to develop into marketable products (when pricing in the cost of failures). This means that no one, aside from megacorporations, can produce new drugs. Medical devices are generally cheaper, but rules still frustrate many would-be developers.

The problem is both alleviated and exacerbated by the regulatory capture of the FDA. Companies with more influence may face an easier time with FDA approval, which lowers their R&D costs but makes us less safe and raises entry barriers even higher.

It is clear that compromise is necessary to ensure the safety of Americans while encouraging investments into new medical device and drugs. But I lean toward strict safety requirements – it seems likely to me that more lives would be lost due to laxer rules than would be saved with faster approvals.