Washington Editor

WASHINGTON - Internal dissatisfaction is mounting at the FDA, according to a newly released survey, and the agency's user-fee system seems to have a big role in its off-putting atmosphere.

"Concerns about the user-fee programs were not surprising," Susan Wood, a former high-ranking FDA official, told BioWorld Today. Survey respondents indicated multiple deleterious consequences of the Prescription Drug User Fee Act (PDUFA) and similar laws, which overall these days account for nearly a fifth of the FDA's annual budget.

First, Wood pointed to frustration among FDA staff who feel pressure working under the laws' review-time constraints, as well as growing workloads. "The amount of resources provided by PDUFA was not adequate to compensate for the flattening, or the loss, of regularly appropriated dollars."

More troubling, survey respondents bolstered allegations of a growing coziness between the FDA and the industries it regulates. Wood, who left the agency last year over the politicized Plan B contraceptive application and now is a professor at George Washington University, described "a culture toward approval" borne on the user fees, an "apparent or real conflict of interest" that stems from "inappropriate influences pushed to the front burner."

With negotiations under way to reauthorize PDUFA next year, she said "these concerns have to be front and center" in any discussions on the law's next iteration, as well as for other user-fee programs. "The voices of those doing the work, the voices of the reviewers and the rest of the agency need to be taken seriously."

Woods spoke at an event here last week in which new survey results demonstrated negativity within the FDA. Almost 1,000 agency staffers answered the anonymous questionnaire, which was sent to nearly 6,000 employees by an organization called the Union of Concerned Scientists. Most respondents were classified as senior-level employees; the agency employs more than 10,000 people.

The survey found that almost one in five respondents have been asked to "inappropriately" exclude or change their reviews for non-scientific reasons, said Francesca Grifo from the Union of Concerned Scientists. More than a third said they can't voice safety concerns within the walls of the FDA, and 40 percent indicated that they fear retaliation for publicly airing such worries.

"Their ability to regulate has been compromised," Grifo added, noting "interference with scientific determinations, negative effects on public health, chilling effects on scientific candor," as well as "the pressures that they face just trying to do their jobs on a daily basis."

Among other survey results: 81 percent feel that the public would be better served if the FDA's post-approval safety monitoring was strengthened, 70 percent do not think the agency has sufficient resources to safeguard public health, 61 percent described improper interventions by political appointees at the FDA or the Department of Health and Human Services and only 47 percent think that the agency routinely provides complete and accurate information to the public.

In response, an FDA spokesperson called the survey "highly unscientific," charged that it employed "leading questions and innuendo" and questioned "what percentage of those who replied to it are actually involved in scientific decision making." The agency "would expect more rigor to support such far-reaching allegations and conclusions."

Nevertheless, the survey results did not go unnoticed on Capitol Hill.

Sen. Chuck Grassley (R-Iowa), a frequent FDA critic, issued a statement saying that the agency "needs a major overhaul and a culture change at the highest levels." He went on to say that the agency should shed "its mindset that it's a facilitator for the drug industry and become a regulator once again."

Those thoughts were echoed in the lower chamber. Rep. Rosa DeLauro (D-Conn.) said the survey results confirm "that the FDA has a credibility problem when it comes to protecting the public health," and Rep. Maurice Hinchey (D-N.Y.) laid blame on the user-fee system that has "made the FDA beholden to drug company interests."

Last year, he introduced a bill called the FDA Improvement Act (H.R. 2090) that would eliminate all user fees that feed the agency's budget, among other things, and Hinchey said he hopes the new survey results help him advance the proposed measure.

In addition, newer FDA-related legislation has been made public by Sens. Mike Enzi (R-Wyo.) and Ted Kennedy (D-Mass.). A draft of their bill, the Enhancing Drug Safety and Innovation Act, was unveiled last week.

Principally, it would give the agency more power to regulate drugs after approval. All clearances would include risk evaluation and mitigation strategies that would be reviewed by the FDA and drug companies at least annually for three years, as well as in supplemental applications for a new indication, when the company suggests changes or when the FDA requests a review. Should a company fail to comply, the agency could impose civil monetary penalties.

In addition, the bill includes a proposed clinical trial registry that would establish a publicly available database to replace ClinicalTrials.gov, which would cease operations but remain publicly accessible. Late Phase II trials, as well as Phase III and IV studies, would be required to register, with all Phase III and IV results to be posted, as well.

The measure also would improve the FDA's process for screening advisory committee members for financial conflicts of interest and establish a biomedical research group as a public-private partnership at the FDA to advance its Critical Path Initiative.

It is expected to be introduced before next month's congressional recess.