Democrats and Republicans on the House Energy and Commerce Committee are pointing fingers at each other behind the scenes over a witness invited to testify at a hearing Thursday about how the federal government approves medical devices.

The witness consults for a medical device company, New Jersey-based ReGen Biologics Inc., whose intense lobbying at the Food and Drug Administration led to the FDA's approval of a disputed knee surgery device in December. The decision is now under investigation by the committee, Sen. Charles Grassley, (R., Iowa), and the Inspector General of the Department of Health and Human Services. The FDA is also reviewing its approval of the device, an unusual move for the agency.

Further complicating matters is that the chair of Thursday's hearing, Rep. Frank Pallone Jr. (D., N.J.), contacted the FDA on behalf of ReGen to discuss the knee device, and received $8,900 in campaign contributions from the company's executives last year. Mr. Pallone has said there is nothing unethical in his calling the FDA on behalf of a constituent from his home state. He has since co-signed a letter to the FDA asking the agency to review the decision. Mr. Pallone's staff declined to comment for this story. They didn't say whether Mr. Pallone would recuse himself from the hearing if the ReGen matter was discussed.

Senior committee Democratic staff say Republicans on the Energy and Commerce health subcommittee invited the witness, former FDA official Philip Phillips, to represent industry's viewpoint that the FDA's approval process for medical devices works effectively. Mr. Phillips, who works in Washington, did not respond to calls or emails seeking comment.

Republicans, Democrats say, should have known he represents ReGen in the knee device approval controversy. For their part, Republicans say they weren't told of Mr. Phillips' involvement in ReGen, but it was up to the Democrats, who are in the majority, to vet all witnesses for potential conflicts of interest or otherwise touchy situations, according to committee staffers.

It's unclear whether the ReGen issue will be raised Thursday, but it seems like an appropriate setting. The hearing is being held to discuss the FDA's use of a speedy approval procedure for certain medical devices, called the 510-K process. ReGen's knee device, Menaflex, was cleared in a 510-K application over the objections of FDA reviewers.

The process does not require major clinical studies on safety and efficacy, and was intended for products that have only limited risks. But a government report this year said 510-K approvals are being overused and former FDA Commissioner Andrew von Eschenbach has said that the fast-track process is "out of control."

Missing from the hearing will be representatives from the FDA. Rep. Mike Burgess (R., Texas), who is a physician and serves on the health panel, asked the committee to investigate Menaflex's approval in March. In an interview Wednesday he said, "The committee should have asked the FDA to testify about the 510-K process. I want to know what they have to say."

Mr. Phillips isn't the only witness at Thursday's hearing with Menaflex ties: Peter Lurie of the consumer safety group Public Citizen led his organization's campaign to stop the agency from approving Menaflex, which he has called a prime example of the excessive use of the 510-K process.

No one inside or outside ReGen has been accused of wrongdoing. The main issues under review is whether FDA officials caved to ReGen, whose representatives, including Mr. Phillips, aggressively lobbied the agency and enlisted politicians. After FDA scientists objected to the device in late 2006, Mr. Phillips wrote a top official, saying, "Please do not interpret this note as an attempt to apply pressure."

He added, "If we do not see some signs of progress, I am not sure that I can continue to convince (CEO) Gary Bisbee and the ReGen board to remain patient."

The company has said the device is safe and works well in knee surgery and that FDA regulations on 510-K procedures were an appropriate standard by which to approve their product.


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