‘Inspecting More but Enforcing Less’: Study Finds Poor FDA Regulation

The Food and Drug Administration campus in Silver Spring, Md. (AP Photo/Andrew Harnik, File)

(CN) — An investigation by the journal Science has discovered numerous systematic failures in how the U.S. Food and Drug Administration has regulated clinical trials since 2009, to the detriment of volunteers’ safety and the scientific enterprise.

One of the FDA’s tasks is to verify that medical products and treatments, including new pharmaceutical drugs, comply with federal regulations intended to promote patients’ health and safety. Clinical trials, which test the safety and usefulness of new medical interventions, must comport to certain requirements: volunteers must be informed of the risks and consent to be tested on, for instance.  

Investigative journalist Charles Piller examined FDA databases, submitted open-records requests and spoke to whistleblowers familiar with FDA inspections that were carried out during Barack Obama’s presidency and the first three years of President Donald Trump’s FDA.

“In nearly all enforcement, FDA’s record has been declining,” Piller said in an interview. “They’re issuing fewer so-called ‘official action indicated’ inspections.”

When an OAI classification is issued, government officials are required to perform a second inspection or take other action. Cases classified OAI are often downgraded to “voluntary action” status, Piller said, which does not require federal follow up.

“Fewer and fewer times are they finding problems that require correction; more and more, they’re either saying there are no problems, or there are issues that should be voluntarily addressed by the researcher or the institutional review board,” Piller said. “That’s been a trend since the beginning of the Obama administration.”

Piller explained that in Obama’s first three years in office, the FDA issued 99 warning letters to clinics. In his last three years, only 36 were issued. The FDA has issued only 12 warnings since Trump took office.

“Everything dropped off the cliff under Trump,” Piller said. “Under Trump, the number of inspections that took place actually increased, and the budget increased. … The agency is inspecting more but enforcing less.”

An FDA spokesperson reportedly told Piller that the number of warning letters can “ebb and flow.”

Piller found that at least 220 OAI cases did not meet a definite end, such as a disqualification of the clinical trial or a letter indicating that the clinic adequately remedied its errors.

Though federal inspectors found numerous, flagrant violations of clinical trial regulations, the agency rarely penalized or sanctioned the offenders. A Utah clinic, for instance, routinely failed to obtain informed consent from volunteers and neglected to report unusual results or participants’ use of drugs that may skew results

But agency officials didn’t issue press releases or otherwise publicize the offenses. Trial participants that may have been put at risk and the companies whose devices and drugs were improperly tested were not informed of the clinic’s misconduct.

Piller said he issued hundreds of Freedom of Information Act requests — which permit citizens to obtain public documents pertaining to federal officials’ activities — in the course of his investigation. An independent company, Govzilla Inc., helped him file these often costly records requests.

He found that at least one researcher promised to never conduct another clinical study, then broke his promise with no apparent blowback from the FDA.

When the FDA warned researchers that they were breaking the law — an infrequent occurrence — agency officials apparently often took scientists at their word, closing investigations without verifying claims that federal regulations were being met.

In one 2016 case, a Texas research firm submitted a plan to the FDA explaining how it would stop overdosing kidney-impaired trial participants with drugs that could further harm their kidneys. According to the investigation, the FDA told the firm its plan was inadequate, then closed the case that very same day.

In 2018, Piller wrote, the advocacy nonprofit Public Citizen brought attention to a Minnesota hospital’s reckless use of the sedative ketamine on emergency room patients who were neither informed nor agreed to participate in a clinical trial.

Though FDA inspectors confirmed these ethical breaches, the situation did not result in either an OAI classification or even a warning letter — and the Science investigation found that the FDA was already aware of alleged problems with this research trial, years before Public Citizen had sounded the alarm.

“It’s important to understand that the agency’s lax, sluggish, secret process for enforcing clinical trial laws and rules has some troubling implications for Covid-19 research,” Piller told Courthouse News. “The White House is pressing for results, vaccines and remedies — clinical trials can’t be rushed; they certainly can’t be rushed faster than the science and the patients’ safety would allow. The agency, under Trump, has been increasingly hands-off in overseeing human-subject experiments.”

Improperly administered trials pose a risk to volunteers’ health and make it more difficult for scrupulous scientists to develop and distribute proper treatments.

“The likelihood of harm to patients from rushed or improper trial design, or improper management or fraud, certainly is present and perhaps high. Just as important, poorly run trials can taint the data stream used to approve treatments for general use or emergency use, which is an important tool the FDA has,” Piller said. “It can undermine evidence-based medicine.”

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