The FDA Drug Approval Process Has Problems—But It Is Not Corrupt

Is the US drug approval process corrupt? Many critics say that it is, leveling the charged rhetoric of corruption at the Food and Drug Administration (FDA) (see, for example, here, here, and here). Yet there have been few, if any, credible allegations of illegal bribery or the exchange of quid pro quo benefits in relation to FDA drug approvals. Rather, when critics speak of “corruption” at the FDA, they are alluding to a perhaps all-too-cozy relationship between the FDA and the pharmaceutical companies it regulates. That is indeed a source of concern: Big business likely has too much sway in Washington, D.C. on a whole range of issues, and the FDA is not immune to the powerful influence of powerful lobbies like Big Pharma. Yet the casual deployment of the rhetoric of “corruption” in this context, though offering attractive click-bait, is both misleading and potentially counterproductive.

It’s helpful to try to nail down precisely why critics accuse the FDA of corruption. Much of the concern, as noted above, focuses on the allegation that the FDA is beholden to the interests of the pharmaceutical industry. But when one scrutinizes the drug approval process more closely—even in cases where it appears something went wrong—it turns out to be hard to document the details of just how the industry has improperly influenced FDA operations. The recent firestorm over the FDA’s approval of Aducanumab, a controversial Alzheimer’s therapy, provides a useful illustration. The FDA’s decision to approve Aducanumab was met with fierce backlash, with critics arguing that the approval was not supported by the FDA’s typical standards of efficacy and that the agency assumed an uncharacteristically active role in the approval process. Subsequent investigations, including an 18-month congressional review of 500,000 pages of materials, resulted in a “scathing” report that concluded, among other things, that FDA officials deviated from FDA documentation protocols and had some inappropriate collaboration with Biogen, the drug company that makes Aducanumab. Yet this in-depth investigation failed to uncover any evidence of quid pro quos or other misconduct that would be properly labeled “corruption.” Inferring that corruption must have taken place—or why else would the FDA have approved an expensive drug with low efficacy?—overlooks the legitimate reasons the FDA might have had for approving the drug, including the “substantial unmet need” for an effective therapy for a deadly disease affecting roughly 6 million Americans.

Some might respond to the claim that approval process does not involve any quid pro quo exchanges by pointing out that the FDA drug approval process is funded largely through user fees collected from pharmaceuticals manufacturers; this financial reliance, the argument goes, leads the FDA to provide favorable treatment in the approval process (see here and here). But this does not follow. Although drug makers do remit substantial fees to the FDA, these (publicly disclosed) payments are validly exchanged for the time and resources required for the FDA to evaluate therapies. The FDA’s cost-intensive and technical services provide both a private benefit to pharmaceuticals and a public benefit to those who receive effective approved treatments. Accordingly, mandatory payments to the FDA’s operating budget are a far cry from undisclosed bribes to individuals working in a position of entrusted authority.

Other claims of a “corrupt” FDA are similarly lacking in specifics. Take, for example, allegations that the FDA’s accelerated approval process affords the agency undue discretion to play favorites. Critics advancing this argument, however, have failed to establish that the agency has granted expedited review to particular drugmakers due to improper favoritism; rather, drugs approved under the fast-track process have met fast-track qualifications by treating “serious conditions, and fill[ing] an unmet medical need.” Greater utilization of the accelerated approval process reflects a policy determination that traditional drug approval standards have led to “deadly overcaution” and delays in approving life-saving treatments. Those who have grievances against the FDA’s use of the accelerated approval process should target the standards the FDA has validly applied in these often “life-or-death calculations,” rather than making unfounded claims that the program enables corruption.

Critics also point out, correctly, that certain FDA officials go on to have careers in the pharmaceutical industry after they leave the agency. This may well be problematic. The “revolving door” at the FDA, as with other government agencies, could have an influence on employee behavior. But there is little evidence to support the allegation that drug companies offer FDA officials post-FDA employment as a kind of “after-the-fact” compensation, akin to bribery, for favorable treatment. Furthermore, the FDA has in place restrictions–such as a cooling off period for senior agency officials before they can work in the industry and strict confidentiality rules–that are designed to prevent conflicts of interest. Absent any credible evidence that the FDA’s drug approval process is tainted by the fact that agency employees may later go on to work within, or obtain research funding from, the pharmaceutical industry, the risk that this potential would amount to excessive undue influence is low.

The allegations of improper quid pro quo are even more misplaced when they focus on how members of FDA advisory committees may get research funding from pharmaceutical companies. The kinds of experts selected to serve on these committees are generally at the top of their field, and are unlikely to destroy their careers by engaging in a corrupt relationship with pharmaceutical companies. Furthermore, calling research funding a “personal gain” is a stretch. Instead, conflicts of interests can be meaningfully reduced with less drastic measures, such as enhancing accountability through broader disclosure requirements.  

 Again, none of this is to deny that pharmaceutical companies exert a powerful influence on policymaking, and that this influence has contributed to a host of problems, such as exorbitant drug prices and the opioid epidemic. But it is important to distinguish these important problems from the separate issue of whether the FDA’s drug approval decisions are corrupted by undue influence from drug companies. And the rhetoric of corruption could, if taken seriously, do real harm. Some have suggested that the FDA—which has generally maintained a strong reputation for integrity for over a century—must become an independent agency, or that user fees must be eliminated, or that future employment or research funding from drug makers should be curtailed. Such reforms, however, could have serious unintended consequences, including significant delays in the drug approval process. And restricting those experts who serve on FDA advisory committees from receiving research funding from pharmaceutical companies would curtail pathbreaking research by leading experts. In short, overly aggressive oversight of the FDA is not only unnecessary, but also imposes heavy costs. By all means we should highlight and fix the many problems with the current drug approval process. But overheated accusations of “corruption” amount to a misdiagnosis and exaggeration of the problems, and if taken seriously will result in counterproductive responses.

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