FDA Scientists Say Politics and Industry Sway Regulatory Decisions

FDA Scientists Say Politics and Industry Sway Regulatory Decisions

March 13th, 2012 // 12:47 pm @ jmpickett

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With all the talk of reforming the FDA – speeding approvals, in particular – a new survey finds that most agency scientists believe political and corporate influence have sizeable weight on final regulatory decisions. And more than a quarter of agency scientists feel they are unable to openly express concerns about their “mission-driven” work without worrying about retaliation.

“Despite the Obama administration’s improvements in scientific integrity, political and corporate influence over the FDA’s scientific work persist,” says Francesca Grifo, who heads the scientific integrity program at the Union of Concerned Scientists, in a statement. The non profit that conducted the survey of 997 FDA staff scientists last year as a follow-up to an earlier survey in 2006.

Yet at the same time, a majority of FDA scientists believe the agency is moving in the right direction; that their direct supervisors stand behind scientists who propose potentially controversial positions, and that the FDA is acting effectively to protect public health. These three specific sentiments, by the way, are also an improvement from responses given six years ago.

The UCS speculates the progress reflects passage of the FDA Amendments Act in 2007, which attempted to make boost agency transparency (read more here). Overall, more than 71 percent of FDA scientists respect the integrity and professionalism of FDA leadership, a big jump from 44 percent six years ago, before Andy von Eschenbach was replaced by Margaret Hamburg.

As an aside, the results appear shortly after the US Department of Human & Health took the unprecedented step of overruling the FDA on allowing greater access to the Plan B contraceptive pill (see this). Since then, the UCS notes that both the FDA and HHS released scientific integrity policies, although they failed to open the policies to a public comment period.

On some counts, though, the agency is not inspiring tremendous confidence among its ranks. Here are some highlights – or lowlights, depending upon perspective – of what scientists who work at the Center for Drug Evaluation & Research and the Center for Biologics Evaluation & Research had to say in response to several of the more than two dozen survey questions…

Roughly 19 percent of the scientists at both CDER and CBER believe political interests have “a lot of weight” in making decisions. Agencywide, 30 percent of staff scientists have this complaint. When including those who believe political interests have “some weight,” the CDER response jumped to 48 percent and the CBER response rose to 58 percent. Agencywide, the proportion was 62 percent.

ucs-fda-survey-piesAnd business interests? At CDER, 17.4 percent of staff scientists and 20.5 percent at CBER believe they carry a “lot of weight.” Throw in those who believe business interests have “some weight” and you get 53 percent of the scientists at CDER and 60 percent of those at CBER. Across the FDA, more than 62 percent of the scientists say the same thing.

At the same time, 34 percent of CDER scientists and more than 25 percent of CBER scientists report that public health has been frequently or occasionally harmed by businesses witholding safety information from the agency. Among all FDA scientists, the figure was 37 percent.

“Subtle pressure from leadership is very difficult to quantify and regulate, but it exists and is a problem,” an unnamed CDER scientist told UCS. “I am frequently told that senior management ‘doesn’t want to have to deal with a dispute’ and am therefore subtly pressured to make a favorable decision (to industry). I have several times been required to provide a special briefing to management if I believe a product should not be approved – this has never been required when I recommend approval. This adds stress and takes away from already limited time to do my job, and is a subtle form of pressure that always seems to go in the direction of drug approval.”

Meanwhile, 22 percent of CDER scientists and 25 percent of CBER scientists reported “frequent” or “occasional” experiences in which members of Congress forced the withdrawal or significant modification of an FDA policy or action that was designed to protect public health. Agencywide, the proportion was 30 percent. Not majorities, but not small numbers, either.

There was less interference from non-governmental types, such as advocacy groups, when it came to forcing the withdrawal or significantly modifying an FDA policy or action designed to protect consumers or public health – 22 percent of CDER scientists reported this experience “frequently or occasionally,” and nearly 16.5 percent of CBER scientists. Agencywide, the figure was almost 23 percent.

Other nuggets: almost 20 percent of CDER scientists and 15 percent of CBER scientists say that selective or incomplete use of data was frequently or occasionally used to justify a specific regulatory outcome. The agencywide figure was 20 percent. And 20 percent of CDER scientists and more than 18 percent of CBER scientists say they can publish work in peer-reviewed scientific journals regardless of the level of controversy. Agencywide, the figure was 21.6 percent, down from 27.5 percent in 2006.

There were also questions asked specifically of CDER scientists. For instance, just 10 percent say they were pressured to approve or recommend approval for a New Drug Application despite reservations about the safety, efficacy or quality of the drug. More than 86 percent were very or somewhat confident that final decisions adequately assess safety. And 69 percent were very of somewhat confident that the FDA adequately monitors safety once drugs are on the market.

Among CBER scientists, nearly 24 percent reported pressure to approve or recommend approval for a product despite reservations about the safety, efficacy or quality. More than 92 percent were very or somewhat confident that final decisions adequately assess safety. And 70 percent were very or somewhat confident the agency adequately monitors safety of biologics once these are on the market.