WASHINGTON _ House Commerce Committee Chairman ThomasBliley (R-Va.) Wednesday described the principles of FDA reformlegislation that he supports which would put private reviewers incharge of drug approvals with FDA retaining a watchdog role.
"We need a level of regulation no greater than necessary," Bliley toldattendees at a conference held by the Progress and FreedomFoundation, a conservative research and advocacy group inWashington.
Bliley, whose version of FDA reforms has been eagerly awaited bythe drug industry, did not announce any specifics. He spoke ingeneral terms about his planned bill, and said that he backedenactment of FDA reforms that "rely on non-government reviewers"over whom the FDA would maintain oversight. In addition, theagency would retain authority to conduct compliance. "We willtransfer authority to third-party private reviewers wheneverappropriate," he told the conference. He also announced that hiscommittee would begin hearings on FDA reform legislation Feb. 27,1996.
Such legislative relief is not a sure thing, however. Bliley said thatwhile he and House Speaker Newt Gingrich (R-Ga.) "hope" FDAreform will clear the House this year, he noted that 1996 is apresidential election year, complicating legislative action on anumber of bills.
Bliley offered the most detailed description yet of what he views asthe attributes of FDA reform. Bliley was adamant that the FDAreduce the time and cost of the drug discovery process to speed drugsfrom the test tube to the patient. He also stressed that the FDA shouldnot attempt to control the dissemination of information to physicians.
Bliley praised the proposal unveiled Wednesday by the Foundationthat relies on privatization of key FDA functions to speed drugs tothe marketplace, an approach "that ensures that government getsinvolved only when necessary," Bliley said.
The Foundation proposal, which is expected to get a warm receptionamong conservative Republicans on Bliley's committee, would shiftthe FDA's focus from regulating products to certifying and regulatingthe private review entities. Under the plan, the FDA would lose itsmonopoly on drug approvals which would be farmed out on acompetitive bid basis to Drug Certification Bodies that wouldcompete on the basis of providing timely and cost-effective reviews.The private reviewers would have to maintain current FDA standardsfor establishing safety and effectiveness.
The Foundation's proposal was praised by Thousand Oaks, Calif.-based Amgen Inc.'s George Rathmann as a necessary one to give theFDA "world leadership in regulatory approvals just as the U.S. leadsin drug discovery." Rathmann, board chairman emeritus, who madebrief remarks to the conference, ascribed most of the FDA'sregulatory slowness to the prodigious size of new drug applications(NDA), clinical holds imposed on testing, rigid dosing requirements,and multiple Phase I studies.
The growing complexity of the FDA drug approval process wasdocumented by Joseph DiMasi, director of economic analysis at theTufts Center for Drug Development, in Boston. Citing data showingthat the complexity and size of clinical trials have markedly increasedover the past decade, DiMasi termed a 10- to 15-year drug discoveryprocess as "unacceptable." DiMasi demonstrated that while thelength of the NDA process has held steady since 1962, theinvestigational new drug phase has doubled in the last five years. Theresult is that the time from discovery to approval has increased from8.1 years in the 1960's to 14.6 years in the 1990s.
DiMasi also said that the complexity of clinical trials has increased asdemonstrated by a 69 percent in the number of procedures performedper patient in Phase I clinical trials, a 119 percent increase forpatients in Phase II studies, and a 59 percent increase in Phase IIIstudies. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.