By Lisa Seachrist

Washington Editor

WASHINGTON — With the Sept. 30 expiration of the Prescription Drug and User Fee Act (PDUFA) looming, the Senate bill encompassing its reauthorization as well as broader FDA reform appears set to hit the Senate floor Tuesday or Wednesday.

Senate Majority Leader Trent Lott (R-Miss.) said late last week he would schedule the bill, S. 830, sponsored by Sen. Jim Jeffords (R-Vt.), this week if the Labor and Human Resources Committee could hammer out the remaining issues in the bill.

"Sen. Jeffords is focusing on resolving with committee members issues about provisions in the bill," a Jeffords' spokesman said. "I expect that we will have the bill ready for next week. There are a lot of productive discussions taking place."

In order for Lott to schedule debate on the bill, Labor and Human Resources Chairman Jeffords and ranking minority member Sen. Edward Kennedy (D-Mass.) must agree it is time for the bill to be presented to the Senate as a whole. As-yet-unresolved issues include provisions on Phase IV trials and pharmacoeconomics.

Kennedy is concerned the FDA lacks the authority to enforce requests for trials after the drug has been approved. He originally backed a plan to assess civil penalties to companies that fail to perform clinical trials the agency requests after the drug is approved for marketing.

Jeffords' spokesman noted the Phase IV issues are still being discussed, but stated, "I think we are off the civil penalty issue."

In addition, the committee still must come to agreement on how the FDA will use pharmacoeconomic data. However, it seems likely the agency will use these types of data only for allowing companies to make economic claims, rather than as a measure of effectiveness.

User Fee Act Not An Issue

Since the bill's markup June 18 the various committee staffers have worked out agreements between members and the agency on several of the bill's provisions. While none of the PDUFA provisions caused any strife, the FDA was concerned with several other provisions.

For example, Sen. Christopher Dodd (D-Conn.) included a provision during markup to allow patients with no other options access to experimental treatments if their doctors considered it necessary. The FDA already runs a program that provides investigational drugs to patients and was concerned the Dodd amendment would interfere with those programs.

The agency and the committee agreed to codify the existing emergency access and treatment IND proposals with the caveat the decision to use the drugs would lie with the patient's physician. The agency maintains control over reimbursement issues.

In addition, the bill allows pharmaceutical sponsors to submit abbreviated data on all supporting clinical studies, requiring that they submit full data sets only for safety and pivotal studies.

Most of the other agreements have concerned provisions aimed at the medical device industry, such as third-party review and review times.

Jeffords' spokesman said, "I am very optimistic that this next week is going to be a happy experience. I don't know of any planned amendments to or holds on the bill." *