The FDA: Does it Protect OR Hurt Us?
Medical decisions are based on a benefit to risk assessment. In choosing the therapy, the benefit should always be greater than the risk. But of course, the analysis is based on available information that is never perfect. Thus, there is frequently an element of judgement before the final decision can be made.
This is much more complicated for the U.S. Food and Drug Administration (FDA) which is charged with assuring the safety (The Federal Food, Drug, and Cosmetic Act, June 24, 1938) and efficacy (The Kefauver-Harris Amendment, (October 10, 1962) of thousands of consumer products worth about a trillion dollars annually, most visibly drugs. The FDA is a prime example of how imperfect information drives decisions. If the FDA approves a drug that turns out to be harmful it becomes front page news with serious repercussions for the agency and loss of jobs. If on the other hand it greatly delays or blocks a drug that improves an illness, there is little to no negative publicity. Additionally, in a 17,000-person federal bureaucracy there is no room for judgement, so that the demand is for voluminous amounts of information, which is also never perfect. Over time the agency developed a much longer approval mechanism that is inordinately expensive driving up the cost of medications, limiting drug development to mostly large corporations with huge financial resources; approvals, if obtained, take approximately a decade. It should be noted that in Europe approvals take far less time with no additional risk.
The case of vaccines for SARS-CoV-2 became a far different matter. Because of Operation Warp Speed the federal government paid billions of dollars in advance to purchase vaccines for the American public, which along with spectacular progress in molecular biology created the possibility of providing protection against the virus in less than a year rather than the usual decade. This demonstrated that under stress conditions FDA drug approvals could be done in a much shorter period of time
However, even in this crisis our FDA with 17,000 employees is lagging behind Great Britain’s drug approval body with 1,320 employees. This indicates that there are many lessons the FDA can learn from its British colleagues as to how to further streamline its approval process.
But can the FDA meet the challenge and learn how to expedite future drug approvals or will it return to its hyper careful 10 year tradition? Keeping in mind that with huge federal deficits it will eventually have to do so with less funds and manpower, I am skeptical.
