With a roster of Democrats ready to add bipartisan muscle to his effort, Rep. Edward Whitfield, R-Ky., Thursday night introduced the Food and Nutrition Reform Act, the third leg of the House FDA reform effort.
The bill got its bipartisan boost from House Commerce ranking member John Dingell, D-Mich., who led a group of Democratic cosponsors. A Republican Commerce Committee aide applauded Dingell's move.
"This is the result of two-and-a- half years of extensive outreach by committee Republicans," the aide said. "We worked hard to find common ground."
The bill will be considered together with the two other parts of House FDA reform legislation, both of which are being introduced in the form of substitute amendments to existing bills.
House Commerce Chairman Bliley and Health and Environment Subcommittee Chairman Michael Bilirakis, R-Fla., Thursday issued a "discussion draft" of an amendment that will serve as a substitute to the "Prescription Drug User Fee Reauthorization and Drug Modernization Act of 1997." The Commerce aide said that details of a separate amendment covering medical devices will be released today. He added that Bliley was hoping to schedule a markup of all three measures in the Health and Environment Subcommittee early next week.
The prescription drug amendment reauthorizes the Prescription Drug User Fee Act of 1992 for five years, according to a summary of the discussion draft released by the committee. It contains several measures not included in the "Better Pharmaceuticals for Children Act," sponsored by Rep. Jim Greenwood, R-Pa., which establishes a program designed to provide incentives for clinical trials among children for investigational new drugs and approved drugs.
Among the incentives are the extension by six months of market exclusivity allowable under current law for such drugs tested under agreement by the HHS secretary and the drug sponsor. Any study required under the FDA's recently proposed pediatric regulation would qualify for the extended exclusivity.
The measure sunsets on Jan. 1, 2002, after which the secretary must report to Congress on the program.
Also, a list must be published, the bill says, of approved drugs for which more research may produce benefits to children.
It also establishes a new program under which the HHS secretary is to expedite the development and approval of "fast track drugs," or those designed to treat serious illnesses and which could meet currently unmet needs.
The HHS secretary is required to publicize the new fast track drug provisions.
Also new is a provision that expands patient access to drugs to treat ailments for which there are no alternative therapies.
The physician must determine that the risk from the drug is not greater than that from the disease.
In addition, the drug manufacturer must pursue marketing approval and not interfere with clinical studies.
Any person, through a physician, could obtain a drug under investigation.
The amendment also provides for the dissemination to medical providers of certain off-label information on medical treatments.
And, it authorizes the HHS secretary to establish a database "relating to the treatment, detection and prevention of serious or life-threatening conditions," according to the discussion draft.
However, the GAO is required to study the likely effect of the provision.
The three House FDA measures are to be combined at a later date, according to the Commerce Committee aide.
The Senate is considering its FDA legislation as a single measure.
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