As transformative as the Pure Food and Drug Act and the creation of the FDA has been to the health of Americans, the agency has not been without its missteps. For instance, as the body with the most direct oversight of the pharmaceutical industry in the U.S., many believe they should shoulder much of the blame for the continuing opioid crisis. The American Medical Association’s Journal of Ethics points to the FDA’s allowance for the promotion of opioids to treat chronic pain and their “failure to obtain evidence of long-term safety and effectiveness” of the drugs as major contributing factors to the crisis.
Now, a new report by the Reagan-Udall Foundation for the FDA includes findings that may pose an existential threat to the agency, says the Washington Post. The Reagan-Udall investigators were tasked by FDA itself to assess internal strengths and weaknesses, and they found that its staff was overburdened and stretched thin, that there had been serious failures of internal communication, and problems with their existing leadership. The report was spurred by the infant formula crisis, which saw four babies sickened, and two left dead due to improper oversight of the sanitary conditions at an Abbott production facility.
The Reagan-Udall Foundation report includes some sweeping recommendations for the FDA, the most drastic of which would see the organization fragmented in an effort to put more emphasis and oversight on the “human foods” segment of their…
