By Lisa Seachrist

Washington Editor

WASHINGTON -- Citing alienation from the process and industry control over the final bill, a group of patient organizations is urging senators to oppose Sen. Jim Jeffords' (R-Vt.) plan for FDA reform and renewal of the Prescription Drug and User Fee Act (PDUFA) when it hits the floor this month.

The group maintained that the bill, S. 830, would only serve the interests of the industries regulated by the FDA, while weakening protection of the public health.

"This bill is mislabeled. What is modern about untested, unsafe or misleading products?" asked retired Sen. Howard Metzenbaum, an Ohio Democrat and chairman of the Consumer Federation of America. "Overwhelmingly, the American people trust the FDA more than industry to ensure the safety of products."

"The Jeffords FDA bill is a grab bag of goodies for the drug and medical device industries," said Joan Claybrook, president of Public Citizen. "It's not surprising, because industry has had its finger in every piece of this pie."

In addition to the heavy role industry played in drafting the bill, the group is protesting that Jeffords and the staff of the Senate Labor and Human Resources Committee provided little opportunity for patient organizations to voice their concerns.

"There have been two minimal hearings on the issue of FDA reform," said Lisa Cox, of the National Women's Health Network. "But there has been no hearing on the bill itself. So there are huge parts of the bill that never got a hearing. It is terribly unfortunate that patients and consumers have been left out of this process."

A major concern for the group is the provision for third-party review of medical devices. The group maintains that by allowing industries to hire contractors to review their products, manufacturers can functionally skirt an FDA safety review.

"The inherent conflict of interest is like asking Mike Tyson to referee a boxing match," Claybrook said, calling the proposal "reckless."

In addition, the patient organizations contend that S. 830 provides for insufficient monitoring of drugs and devices after approval. Cox said the patient advocates support a provision that would assess civil penalties to companies that fail to complete the postmarket studies requested by the agency.

"Postmarking studies are very important, especially to women," Cox said. "Drugs are typically tested on fewer women, and they could have a huge impact on women and any kids that they want to have."

Cox said none of the organizations opposes reauthorizing PDUFA, which is set to expire at the end of September, but noted it was unfortunate that the bill contains so many other provisions.

"It is an unfortunate reaction to anything that augurs change at FDA," said Carl Feldbaum, president of the Biotechnology Industry Organization (BIO), in Washington. "I am especially concerned that they have mistaken the facts."

Feldbaum called any implication that the safety standard has been lowered "plain dead wrong. The protections for patients are solid and undiminished."

In addition, Feldbaum said many issues raised by the patient group were related to the medical device provisions. "I would certainly hate to see problems with devices impede progress made in the biologics and drug provisions," he said.

With PDUFA set to expire and the agency required to send out layoff notices 60 days in advance to the 600 employees hired under the act, Congress is operating under a very real deadline. Technically, the agency must hand out pink slips on August 1. However, that is unlikely to happen as the FDA has funds available to extend PDUFA employees for a limited period of time should reauthorization be signed into law after the August 1 deadline.

"We have essentially four working weeks to go and then that's it for PDUFA," Feldbaum said. "Unlike a lot of deadlines in Washington, this is a real deadline."

The House is expected to introduce FDA reform and PDUFA reauthorization late this week or early next week. Any legislation approved by the House would have to be reconciled with S. 830, should it pass the Senate, before PDUFA can be reauthorized. *