Fifty years ago on Wednesday, President Kennedy signed into law the US Food and Drug Amendments. The amendments radically overhauled the way in which manufacturers brought drugs to market. Most importantly, the amendments instituted the four-phase review process and the requirement that manufacturers get informed consent from people receiving experimental drugs. If the past fifty years is any indication, though, its unlikely that FDA’s current regulations are well suited to deal with the changing context of medicine, including clinical trials of stem-cell therapies forecasted with the Nobel Prize Committee’s awarding of their prize in Physiology or Medicine earlier this week.
The amendments’ supporters had good intentions and the regulations have had positive effects overall. Yet the US government is still trying to redress many of their negative consequences. The rules have proven to be outmoded for new circumstances that policymakers did not have in mind when they created the amendments five decades ago.
The four-phase review process requires that manufacturers apply to the FDA and submit drugs for agency review three times—at least. One consequence of the four-phase review system is that it extended the time until consumers could access new therapies. This can seem a small price to pay to assure that drugs are safe and effective, a phrase that has become the slogan for the Amendments. People with new, fast-moving diseases, however, have seen the delay as a death sentence. For example, sociologist Steven Epstein has written extensively and carefully about the response to drug delays in the 1980s and 1990s among the HIV/AIDS activist community. The FDA has responded with changes, such as a fast-track approval system, but these shifts tend to come only in response to dire crises.