By Lisa Seachrist

Washington Editor

WASHINGTON — With the Congressional leadership intent upon adjourning for the year on Friday, Congressional staffers have been working around the clock to ready FDA reform for a smooth conference committee meeting either today or Thursday.

As was the case in both the Senate and House consideration of this bill, which encompasses FDA reform and the Prescription Drug User Fee Act (PDUFA) reauthorization, the committee members will likely need to iron out a medical device issue in order to produce a conference report. But industry representatives remain confident that both chambers of Congress will pass a bill the president can sign before lawmakers leave town.

"Congress is still working on a Friday deadline for adjournment," said Alan Goldhammer, director of technical affairs for the Biotechnology Industry Organization. "Because of the PDUFA reauthorization, there is a feeling of a great degree of urgency to get this bill passed. I am cautiously optimistic that they can get this accomplished."

"We see a strong possibility that this bill will pass before the end of the week," agreed Jeff Trewhitt, a spokesman with the Pharmaceutical Research and Manufacturers of America. "Most of the major outstanding issues have been resolved by senior staff so that conference members will only have the most contentious issues to deal with."

The largest issue remains a medical device provision known as Section 404 in the Senate version of FDA reform, S. 830. Sen. Edward Kennedy (D-Mass.) vehemently opposed the provision, which would limit FDA's scope of review of low-risk medical devices — the so-called 510(K) devices — to the indication stated on in the manufacturer's label.

Kennedy feared the legislation essentially opened the door to allowing medical device companies to get approval for one indication and market their device for another. He attempted to filibuster the bill to remove the provision, but in the end, S. 830 passed the Senate 98-2 on Sept. 24 with the measure included.

When faced with Democratic opposition to a similar provision in the House bill, Reps. Joe Barton (R-Texas) and Anna Eshoo (D-Calif.) found a means to compromise. Under the agreement, the FDA must still base its decision to approve a 510(k) device on the indication listed on the label. However, should the agency deem that the device will likely be used for another purpose, the agency must notify the manufacturer of its concerns within 10 days. The product label also would need to identify uses for which it has not been approved.

So far, the House and Senate staff have been unable to resolve differences over the House and Senate versions of this provision, and it will likely serve as the major item on the conference committee's agenda.

Goldhammer noted that all of the biotechnology specific issues have been resolved, as the House and Senate versions of those provisions used nearly identical legislative language. However, Congressional staff is continuing to try to hammer out agreements over the exact language to cover incentives for pediatric testing of drugs. There also are some questions as to which version of the antibiotic incentives provision the committee will adopt.

"If you look at the debate, especially in the Senate, medical device issues were the most contentious," Goldhammer said. "All of the major issues dealing with biologics and pharmaceuticals had the same language. We'd like to think that we learned from our mistakes in the previous Congress."

To successfully adjourn by the end of this week, Congress will have to adhere to a grueling schedule, given the fact that several major spending bills have yet to make it to the president's office. Trewhitt noted that while Nov. 7 remains the deadline for adjournment, he wouldn't be surprised to see that deadline pushed back a few days.

"We may have a little flexibility in this time frame," Trewhitt said. "We've been told that we shouldn't hold our breath that Congress will adjourn this week. But we have also been told that Congress probably needs to have FDA wrapped up before Congress adjourns." *

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