EDITORIAL: Working for contributors

Oct 05, 2009 (The Philadelphia Inquirer - McClatchy-Tribune Information Services via COMTEX) -- RGBO | Quote | Chart | News | PowerRating -- Members of Congress often boast about their "constituent services," no doubt hoping voters will picture them cutting red tape for the regular folks they represent. But a recent government report suggests a very different image of the constituents New Jersey's representatives are servicing.

According to a Food and Drug Administration report on an internal investigation, members of New Jersey's congressional delegation exerted extraordinary pressure on behalf of a medical-device maker that wasn't getting its way with regulators. Executives of the company, Hackensack-based ReGen Biologics, have contributed a total of $26,000 to the four Democrats named as carrying water for the company: Sens. Bob Menendez and Frank Lautenberg, and Reps. Frank Pallone of Monmouth County and Steve Rothman of Bergen County.

Ranking FDA officials eventually responded to the pressure, the report says. In December, they approved a ReGen surgical knee implant, overruling agency scientists who had repeatedly rejected the device. Now, the FDA says it is reassessing that approval and trying to draw some larger lessons from the disturbing episode, which several agency employees described as "among the worst experiences in their professional careers."

The FDA's report leaves the impression that, far from righting wrongs for little people, the distinguished gentlemen from New Jersey were working for their big campaign contributors. Their lobbying effort seems to have thwarted federal officials who were doing what they were hired to do, while exposing American patients to what may well amount to a 21st-century version of snake oil.

The politicians' spokesmen have said they merely urged the agency to treat the company fairly and make a decision based on science. But if the FDA isn't already in the habit of treating companies fairly and making decisions based on science, lawmakers should be fixing that, as opposed to engaging in a special pleading for a contributor.

The FDA report acknowledges that calls from members of Congress to the agency are "not unusual." But it goes on to note that the New Jersey delegation's blitzkrieg was "highly unusual not only in the members' persistence," but also in their "interest in specific, substantive aspects of the device's review." One FDA official described the pressure from Capitol Hill as "the most extreme he had seen."

The report also notes that the agency's top officials, led by former FDA Commissioner Andrew von Eschenbach, were remarkably pliant. That gives the public yet another reason to doubt the integrity of an agency whose crucial functions -- including ensuring the safety and efficacy of medical devices -- require that it be beyond pressure and above reproach.

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