WASHINGTON _ House Commerce Oversight and InvestigationsSubcommittee Chairman Joe Barton (R-Tex.) Thursday focused hiscontinuing review of FDA regulatory policies on access to cancertherapies. It was the second in as many days of House hearings onFDA reform legislation.
Earlier this week House Commerce Health Subcommittee ChairmanMichael Bilarkis (R-Fla.) examined some of the controversies nowsurrounding the review of drugs and other medical products but didnot act on specific legislation. (See BioWorld Today, Feb. 28, 1996,p. 1.)
The hearings echoed a common refrain in Congress's current roundof FDA reform hearings: that the FDA should push cancer drugsthrough the approval process as expeditiously as its does AIDStreatment. Several witnesses at last week's Senate hearings on FDAreform legislation complained that that the FDA had respondedpromptly to demands to expand access to AIDS drugs but did notafford the same considerations to patients with cancer and other life-threatening illnesses.
To that end Rep. Peter DeFazio (R-Ore.) has introduced legislation(HR 2019), the Access to Medical Treatment Act. The bill, which isco-sponsored by Barton, would permit patients access to treatmentsas long as "there is no evidence the treatment itself causes harm andthey have been fully informed about the treatment and its possibleside effects," DeFazio said.
The hearings were triggered by the FDA's criminal prosecution ofHouston physician Stanislaw Burzynski for not complying withfederal requirements regarding clinical trials of investigationaltreatments. Many of Burzynski's current and former patients testifiedat the Barton hearing.
Barton praised FDA Commissioner David Kessler for permittingBurzynski's patients to remain enrolled in the treatmentinvestigational new drug (IND) application. Barton said heappreciated that Kessler "cut through the red tape to expediteapproval of Dr. Burzynski's protocols so that these patients areafforded the option of continuing treatment . . . ."
Kessler notified the subcommittee that he could not testify atBarton's hearing because it involved a criminal investigation, onwhich he could not comment. In a Feb. 28, 1996, letter to Barton,Kessler said that the "FDA is fully committed to providing timelyaccess to potentially useful medical treatments to seriously illpatients, especially to those for whom there are not availablealternative therapies. A prerequisite to our being able to do that is thewillingness of the co-sponsors and clinical investigators to undertakethe scientific studies that demonstrate whether a medical treatmentworks, and if so, for and under what conditions."
Access to a treatment IND therapy is cut off only if the FDA puts a"clinical hold" on the protocol, agency spokesman Jim O'Hara toldBioWorld Today.
Rep. Henry Waxman (D-Calif.), who has argued on Kessler's behalfat several Barton hearings, questioned the usefulness of hearings inlight of Kessler's letter "that they would be able to get the drug."Waxman urged the subcommittee to "deal with the broad policyissues that are before us." n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.