The FDA Is Ineffective; How Did It Get This Way?

We’ve been writing about the ineffectiveness of the United States Food and Drug Administration (FDA) for years now. From big-name pharmaceuticals to generic drugs to plastic water bottles to herbal supplements, the agency has consistently failed to protect Americans from corporations willing to jeopardize individuals’ health for their bottom lines.

The educational podcast Stuff You Should Know, in a May 2015 episode, steps beyond the recent controversies to trace the organization’s transformation from the country’s first consumer protection agency in 1906 to its present status as service provider to the drug industry. The show’s hosts cite a Frontline segment called “How Independent Is the FDA?” which consists of interviews with industry experts on all sides of the issue, who discuss three major reasons for the agency’s current ineffectualness: the Prescription Drug User Fee Act (PDUFA); FDA leaders’ unwillingness to stand up to those in the industry; and near-total lack of congressional oversight for the past decade and a half.

First, the PDUFA marked a sea change in the way the American pharmaceutical industry is regulated. From 1906 to 1992, the FDA received funding from taxpayers (via the Treasury), but as more and more drugs were manufactured, the legislature passed a law stating that FDA funds should come from within the industry. This bill was pushed through with help from the industry itself, and was clearly motivated by a desire to churn out medications. Rather than acting as a watchdog group, one expert explained, “[T]he culture at the FDA has become, ‘Please the industry. Avoid conflict. Look upon our role as getting out as many drugs as possible.’”

Appropriately, next is the accusation that FDA leadership lacks the strength to stand up to the companies that have become its paying customers. One academic, “a top candidate to become FDA commissioner in 2002,” says that he was “very proud to be considered” for the spot, but knew he did not stand a chance. “[I]t was very clear that people like myself who care about drug safety, had become too controversial,” he says. He cites his “focus on toxicity and side effects” as reasons he did not get the job.

As for congressional oversight, one critic indicates that whenever the FDA did something wrong, its representatives would have to face a congressional hearing to explain the wrongdoing; “they would be–properly, and in the best public health sense–on the defensive.” He says that in the period between 1992 and 2003 (when this article ran), there had been only one or two hearings. Compare that with “dozens and dozens” of hearings in the previous ten-year period, and it becomes more and more evident that lawmakers, like the FDA, are in the pocket of those they are in charge of regulating.

With regret, the academic who was passed over for the FDA commissioner job says, “To me, the greatest sadness is that people who care about drug safety and food safety to the level that they get involved and they try to make a difference can’t be acceptable to regulate the agency. […] Of course the regulators have to serve [drug manufacturers], but they also have to regulate and they have to protect. To me, protection is first; serve has to be second.”

It is for these reasons that all too often drug safety is left to private citizens and their attorneys. Without adequate oversight and regulatory structures in place, the civil justice system becomes the only recourse people have when facing problems caused by corporations who pay more attention to their sales than to those customers who have been harmed by their products.