By Lisa Seachrist

Washington Editor

WASHINGTON — The first FDA reform bill of the 105th Congress bears a striking resemblance to the efforts of the 104th Congress.

Last week, Rep. Richard Burr (R-N.C.) introduced H.R. 1411, the Drug and Biological Products Modernization Act of 1997 — a bill which is largely based on the Congressman's July draft of H.R. 3199 from last Congress. That legislation garnered 205 sponsors, but ultimately failed to find its way to the floor for a vote during the rush of legislation last September.

"This is a very important issue to [Rep. Burr]; it's near and dear to his heart," said Alicia Peterson, a spokesperson in Burr's office. "He is following through with his promise in January to introduced FDA reform legislation."

The bill is co-sponsored by fellow Republicans Joe Barton (R-Texas), Scott Klug (R-Wisc.), James Greenwood (R-Pa.), Nathan Deal (R-Ga.) and Tom Coburn (R-Okla.). While many of the provisions maintain the same flavor, Burr has removed any mention of the dissemination of medical information, retooled the plan for third-party review and included foods in the national uniformity clause in H.R. 1411.

"The issues from [H.R. 3199] that we considered important for biotech companies are addressed in this bill," said Dominique Khan, director of government relations at the Biotechnology Industry Organization (BIO).

Like Burr's legislation from the previous Congress, H.R. 1411 contains provisions that would require the agency to be more responsive to companies who have a drug in development placed on clinical hold. The legislation would require that agency respond within 30 days in writing to requests from drug sponsors to lift the clinical hold.

"This is also one of the enhancements in PDUFA II [the Prescription Drug and User Fee Act reauthorization efforts]," Kahn said. "Currently, the agency has 30 days to respond, but what we have heard from our member companies is that there is sometimes slippage in the system."

H.R. 1411 also allows for drug approval based on a pivotal clinical trial and supporting evidence. While this standard is written into the biologics law, current law governing standard pharmaceutical approvals is sometimes interpreted to mean that two clinical trials must be performed.

Burr's bill also codifies the biologics rewrite that developed the single biologics license application under Vice President Al Gore's Reinventing Government Initiative. Prior to the regulation, companies that wanted to get approval for a biologic drug had to go through a two-pronged review of an establishment license application and a product license application.

"This was an important change at the agency," Khan said. "We would really like to see it codified into law."

In addition, H.R. 1411 calls for human tissue to be regulated as a drug only if it presents a hazard to public health. This provision is similar to guidelines recently issued by the agency.

Notable among the differences is the absence of the provision to allow pharmaceutical and biotechnology companies to disseminate journal articles that detail off-label uses of a drug. Burr's reform efforts in the 104th Congress began with legislation that solely addressed dissemination of information which he eventually folded into the July draft of H.R. 3199.

Peterson maintained that Burr was still very much in favor of such a provision, but that Sen. Bill Frist (R-Tenn.) had taken the lead on the issue.

Burr also altered the mechanism by which a company would pay for a third party review in H.R. 1411. Several members raised concerns about the third-party review provisions in H.R. 3199 because companies would directly pay the reviewers opening up potential conflict of interest issues. Under the new legislation, a company requesting a third-party review would pay the agency and the agency would contract with, accredit and pay the third party for reviews.

"H.R. 1411 alleviates the concerns over conflict of interest because there is no direct exchange of money between a company and a reviewer," Peterson said.

H.R. 1411 is the first bill to be introduced into Congress. The Commerce Committee also intends to introduce FDA reform legislation. Last year, BIO supported Burr's H.R. 3199. However, the organization has not yet taken a position on H.R. 1411. *