Healthy Skepticism Library item: 9129

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Publication type: news

Heavey S.
FDA Chief Defends Agency Openess, Industry Fees
Reuters 2007 Mar 23
http://www.medscape.com/viewarticle/554084

Full text:

The head of the U.S. Food and Drug Administration on Thursday defended the agency against charges that staff scientists are pressured to withhold their concerns about possible risks of prescription drugs.

At a congressional hearing in the wake of new warnings on a Sanofi-Aventis antibiotic, FDA Commissioner Dr. Andrew von Eschenbach said his staff members were free to express themselves.

“I am adamantly in support of and committed to the protection of legal rights for every single employee within the FDA,” he told the U.S. House of Representatives Energy and Commerce subcommittee.

“I wish to provide an environment… in which people with diverse points of view, completely different perspectives on an issue or problem, can come together,” he added.

Von Eschenbach’s comments come after current and former FDA reviewers last month told Congress the agency’s culture suppresses dissent over safety issues that could affect patients.

Concerns over drug safety were renewed after Sanofi’s antibiotic Ketek was linked to liver failure. In February, the FDA revoked the drug’s approval for sinusitis and bronchitis after deciding it was too risky to use against the two mild infections.

Sanofi can still market Ketek for pneumonia. It was approved in 2004 despite an investigation that found one study was tainted by fraud.

Dr. David Ross, a former FDA safety reviewer for Ketek who previously told lawmakers he quit when managers stifled his concerns about the drug’s risks and fraud, challenged von Eschenbach’s claims.

FOOTBALL ANALOGY

FDA scientists have repeatedly been pressured to keep quiet and reprimanded when they spoke up, he told reporters at Thursday’s hearing.

At one meeting in June 2006, von Eschenbach likened the agency to a football team and said dissent belonged in the locker room and not on the field, Ross said. Employees who did otherwise would be benched or traded. “There’s no doubt in my mind that was intimidation,” he added.

Von Eschenbach told the panel that he did not intend the football analogy as a threat.

During the hearing, lawmakers questioned the FDA’s treatment of its scientists as well as its current system for monitoring drug safety, including its handling of Ketek.

The committee is still investigating the antibiotic and has asked the FDA for related documents. Subcommittee Chairman Rep. Bart Stupak said he would also call Sanofi officials to testify before the subcommittee at a later date.

Representatives for Sanofi could not be immediately reached for comment.

Lawmakers also discussed whether industry fees that fund the FDA swayed the agency to focus more on drugmakers’ interests rather than those of patients.

Stupak, a Michigan Democrat, raised concerns about negotiations between the industry and the FDA over a proposal to renew the fees, asking von Eschenbach for related documents.

Critics and supporters alike agree the FDA needs more money to tackle drug safety issues but are divided over whether the fees should be eliminated, returning the agency to pure government funding.

Asked about such a choice, von Eschenbach said the fees have worked well, adding that full federal funding would place “an even further burden on the American taxpayer.”

“When there’s an opportunity for others to contribute or participate in support of this process, I think it’s appropriate as long as it’s done in an appropriate way,” he said.