WASHINGTON _ Republican House Commerce Committeemembers unveiled the major provisions of their long-awaited FDAreform legislation on Wednesday. The bills include significantchanges to the FDA's authority and operations that go well beyondthe Senate's proposed overhaul but fall short of the radicalrestructuring that critics of reform have assailed.
Reps. James Greenwood (R-Pa.), Richard Burr (R-N.C.), Scott Klug(R-Wisc.) and Joe Barton (R-Texas) _ all members of the House'sso-called "FDA Reform Leadership Team" _ announced their planto introduce a trio of comprehensive bills that would "re-engineer"FDA regulation of drugs and biologics, medical devices and food.Although he was the lone Democrat on hand at Wednesday's CapitolHill press conference, Frank Pallone Jr. of New Jersey called thelegislation a bipartisan effort and insisted the House wants "a finalbill the president will sign."
The proposed drugs and biologics legislation contains key elementsthat biotechnology and pharmaceutical industry representatives havesupported and that the FDA has resisted in recent months. Althoughthe final bill and its exact language were not available as of lateWednesday, a detailed summary listed the following provisions,among others:
* The FDA is to establish standards and procedures for accreditingthird parties (independent non-governmental organizations) to reviewapplications for new drugs and biologics and for conducting goodmanufacturing practices compliance inspections. Sponsors wouldhave the option of submitting their applications to the FDA or to athird party at the start of the review process, not only in cases whereFDA failed to meet its deadlines (as is the case in the current Senatebill).
* The required time period for FDA review and approval ofinvestigational new drug applications would be shaved from 30 daysto 21 days and the agency could accredit institutional review boardsat certain research institutions to approve Phase I and Phase IIclinical trials (currently FDA alone has authority to approve allclinical trials).
* FDA would be given exclusive authority to regulate all new drugsunder clinical investigation, including biotechnology products such asexperimental gene therapy agents that are currently reviewed by theNational Institutes of Health's (NIH) Recombinant AdvisoryCommittee (this would eliminate duplicative NIH and FDA review ofgene therapy).
* FDA would accept "certified accurate and adequate reports ofclinical and preclinical investigations on safety" and "effectivenesstables of the relevant data" from sponsors, while retaining an optionto request primary data tabulations or case report forms if needed.(Essentially, this provision means companies would submitsummaries of their clinical data and analyses rather than a completeset of the raw data as is done now.)
* FDA would be authorized to waive the efficacy requirement for a"well-controlled clinical investigation" (usually defined as a placebo-controlled, double-blinded, randomized trial with prospectivelydefined endpoints) in cases deemed appropriate by the agency.Further, the agency could use a new "clinical experience" option forthe approval of supplemental indications for drugs already approvedwhen the "common use" represents "reasonable clinical practice."(This could significantly lower the efficacy hurdle for adding newindications to an approved drug's label.)
* The bill would revise the regulation of biologics by defining threedistinct product categories: biological products, blood and bloodcomponents, and tissue. It would move the regulation of theseproducts out of section 351 of the Public Health Service Act and intothe text of the Federal Food Drug and Cosmetic Act.
* The dissemination of "certain scientific and medical information"would be permitted as long as it was not used to "encourage theunapproved use of a legally marketed drug or device through anymeans of promotion."
Biotechnology Industry Organization President Carl Feldbaum toldBioWorld Today the bipartisan tone of the House bill was a "pleasantsurprise." He noted there were many differences with the currentform of the Senate bill that would need to be addressed when and ifthe two bills are melded together during the House-Senate conferenceprocess.
"The House bill is more far-reaching than the Senate bill but it is stillcertainly well within the moderate and reasonable zone," claimedFeldbaum. "This is not the radical stuff that critics predicted. It's areal bill that deserves deliberate study."
FDA spokesman Jim O'Hara had no specific response to the HouseFDA reform bills since he had not yet read them. "The agency hasrepeatedly said we think we can do a better job," O'Hara said. "Weare perfectly willing to be held accountable and to meet performancestandards and we are doing that. Many critics continue to talk aboutan agency that no longer exists, if it ever did." n
-- Lisa Piercey Special to BioWorld Today
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