Regulator moves to quell claims it is suppressing evidence

By Ahmed ElAmin

- Last updated on GMT

Related tags Fda Food

The Food and Drug Administration (FDA) will beef up its process for
disclosing the conflicts of interest of its advisory experts, after
a survey suggests it is supressing scientific evidence in favor of
industry.

A survey released last week by the Union of Concerned Scientists (UCS), found a " disturbing level of interference in the agency's research". Many of the nearly 1,000 scientists who responded said they had their work manipulated or suppressed, and fear retaliation if they express their opinions in public, the UCS reported.

While most of the allegations levelled by the scientists related to drug research, many also attacked the agency's integrity relating to food safety. The criticism and the survey's findings have important implications for the public's trust in the FDA's role in regulating the food industry, and by implication in the safety of food products.

This week the FDA moved to stem those concerns, with the announcement that it would make advisory scientists make more public disclosures about their links with industry when publishing their studies.

"This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agency's advisory committees,"​ the FDA stated on Monday. "FDA is taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion."

About one in six FDA scientists who participated in the UCS' anonymous survey said they have felt pressure to change the results of their work for nonscientific reasons.

Sixty-two percent of respondents were senior scientists, and nearly one-third of respondents had been agency employees for more than 15 years.

The USC survey also found 61 per cent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

Only 47 per cent think the "FDA routinely provides complete and accurate information to the public." About 81 per cent agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

About 70 per cent disagreed with the statement that FDA has sufficient resources to perform effectively its mission of "protecting public health…and helping to get accurate science-based information they need to use medicines and foods to improve their health."

In selected excerpts from essay responses submitted by some of the survey respondents, concerns revolved around the FDA's Center for Food Safety and Nutrition (CFSAN), and Office of Regulatory Affairs. Many of the comments said budget cuts were affecting the agency's work. Others said it was being politicised instead of being based on scientific evidence.

"We need more money. We need new equipment,"​ said one scientist about CFSAN. " We should be using the latest analysis techniques & modern technology instead of relying on conventional methods. We should be collecting & analyzing a much larger percentage of import & domestic food samples/products."

Another commentator on CFSAN said: "Over the last several years I have noticed a significant increase in the number of decisions that have become politicized (e.g., increasing requests to review even simple regulations and changes, both by Congress and the Commissioner's office and to make apparently politically-motivated changes in language and sometimes to alter bottom line results), and I think the integrity of scientific work could be improved by minimizing the 'politics' of the process."

Another critic alleged: "I have seen violations that were not prosecuted because legal staff and/or management knew that the time required to prosecute some violations (such as mercury in fish) would take legal resources away from other violations that would have more immediate and severe health consequences (such as microbial contamination in food)."

Another said: "How many leaders in CFSAN'S office of the Director have training in nutrition? These are the leaders who protect the nutritional quality of the US Food supply."

Yet another complained about budget cuts that would make CFSAN "almost useless"​.

In a similar vein one of the respondents called for "increasing resources to permit FDA to maintain itself as a premier regulator of foods, drugs and cosmetics."

In comments on the Office of Regulatory Affairs, one scientist said it should "not ostracize scientists or black ball them because their foresight sees a problem with a drug, device, food, biologics, etc. that possess a potential hazard to health now or in the future."

The FDA is responsible for protecting public health through the regulation of drugs, food, medical devices, cosmetics, and the blood supply - including products that, according to the agency, account for 25 cents of every consumer dollar spent in the US.

The FDA mission statement calls for "helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."

In a recent disclosure sparked by an investigation by sister site BeverageDaily.com, the FDA admitted that it was still finding benzene in soft drinks, even though it had asked industry years ago to ensure the contaminant was not in their products.

Related topics Food Safety & Quality

Follow us

Products

View more

Webinars