FDA concedes buckling under political pressure

The Food and Drug Administration has taken the unprecedented step of acknowledging that it buckled to “extreme” pressure from Capitol Hill in its approval of a knee-repair device last year. While FDA officials call the situation an anomaly, observers said Friday there is nothing to stop similar political lobbying from influencing future decisions.

In a sweeping critique Thursday, FDA leadership said the agency failed to protect its scientists from outside pressure after they twice rejected ReGen Biologics’ Menaflex device.

The Hackensack, N.J.-based company ultimately won approval last December after enlisting the support of four New Jersey lawmakers, who urged then-FDA Commissioner Dr. Andrew von Eschenbach to intervene on the company’s behalf.

Approval came despite protests by FDA scientists that Menaflex - which reinforces damaged knee tissue - provided little, if any, benefit to patients.

The report marks the first time the FDA has openly criticized its own conduct, as Obama appointees try to restore the agency’s credibility after a string of bungled drug and food safety issues.

An FDA official called the pressure from Capitol Hill “the most extreme he had ever seen” and the access granted to the commissioner “unprecedented.” Several staffers at the agency called the ReGen ordeal “the worst experience in their professional careers,” according to the report.

ReGen Chief Executive Officer Gerald Bisbee said in a statement Thursday that FDA’s review involved “procedural irregularities” and did not reflect on the safety of the company’s device.

The New Jersey Democrats - Reps. Frank Pallone Jr. and Steven R. Rothman and Sens. Robert Menendez and Frank R. Lautenberg - received a combined $26,000 in campaign contributions from ReGen executives, according to OpenSecrets.org, which tracks political spending.

Mr. Rothman, who represents Hackensack, said he asked the FDA “to treat ReGen fairly, communicate with them better and to render a decision based solely on the science.”

A spokesman for Mr. Lautenberg said he simply signed a letter to the FDA along with the three other lawmakers.

Calls to Mr. Pallone and Mr. Menendez were not returned Friday.

WBB Securities analyst Steve Brozak said there are probably other examples of FDA decisions influenced by politics, but since the agency controls the paper trail, they probably won’t come to light.

“I would like to think this was an extreme example, but the better part of me knows it was not,” said Mr. Brozak, who covers the drug and device industries. “To think FDA isn’t influenced by political activism is to not understand the system.”

Analyst Ira Loss said federal lawmakers send letters on behalf of companies every day.

“The question is how does the regulator react to the letter,” said Mr. Loss, who has covered the FDA for more than 30 years at Washington Analysis, an investment firm. “In this instance, Dr. von Eschenbach got very interested.”

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