WASHINGTON _ Brandishing statistics that showedthe FDA had reviewed an impressive 96 percent of allnew drug applications (NDA) within 12 months in fiscal1994, FDA Commissioner David Kessler on Tuesday toldan audience at the Food and Drug Law Institute (FDLI)that "there is no drug lag."
Kessler's comments were directed as much at the drugand device manufacturers who sat in the FDLI audienceas they were at Congressional Republicans who haveused charges of a U.S. drug lag to justify their ambitiousplans to reform FDA.
Kessler was followed at the podium by House CommerceCommittee Chairman John Bliley (R-Va.) whosecommittee has jurisdiction over FDA legislation. Whileoffering no specifics on what FDA reform bill hiscommittee would report out, he said the "benchmarks" ofFDA reform include privatization of product reviews,establishment of an FDA watchdog panel with theDepartment of Health and Human Services,reorganization of FDA, including splitting off the Centerfor Devices and Radiological Health, and permittingdrugs on the market that pose some risk to consumers inan effort to grant access to all available therapies.
Kessler's `State of the FDA' speech was seen as"encouraging" by Biotechnology Industry Organization(BIO) President Carl Feldbaum. "The issue of FDAreform clearly has been embraced by all the stake holders,including patients, the industry, the FDA and the WhiteHouse," said Feldbaum.
The Pharmaceutical Research Manufacturers of America(PhRMA) saw the cup described by Kessler as half fullinstead as half empty. "Of the 150 drugs that the FDAapproved in fiscal 1990-1994, 92 were first approved inother countries," said PhRMA spokesman Pat Korten.
Kessler said his remarks were intended to "put to rest theincorrect perception that American patients generallysuffer because of a so-called drug lag. The notion thatimportant, effective drugs are routinely available in othercountries, but not here in the U.S., is today a myth."
Kessler credited elimination of the backlog of drugapplications to the Prescription Drug User Fee Act of1992 which he said provided the agency with thenecessary resources to do the job. He also attributed thesea-change at FDA to "a change in the culture within theagency that has added modern, efficient managementtechniques to its long-standing, solid scientific base."
In 1987 the FDA took nearly three years to approve anNDA. By 1992, review time had dropped to 19 months.
Kessler cited a new study commissioned by the FDAwhich showed the availability of new drugs in the U.S.compared to those approved in England, Germany andJapan. Those four nations constitute 60 percent of globalpharmaceutical sales.
The analysis found for example, that of the 58 drugs thatwere approved in both the U.S. and U.K., 30 of themwere first approved in the U.S. "It's only a slight edgeover the first 28 approved in the U.S. but it clearly showswe are not behind," Kessler said.
The disparity was greater in the other two countries. Ofthe 44 drugs approved in both the U.S. and Germany, 31were approved first by the FDA. And in the comparisonwith Japanese approvals, the U.S. approved twice asmany new drugs, said Kessler.
The FDA analysis also addressed the issue of whether theU.S. was keeping important new therapeutic advances offthe market while other countries were approving them.The agency found that the U.K. had permitted 29 drugson the market while the U.S. had not; conversely the FDAcleared 18 drugs not approved in the U.K.
A closer look at the 29 drugs found two that "might bepriority drugs," including remoxipride and centoxin, abiotech drug. Both drugs were subsequently associatedwith life-threatening side effects and taken off the market,said Kessler. Malvern, Pa.-based Centocor Inc. stoppedclinical trials of centoxin after several deaths werereported.
The FDA Commissioner also took on critics in the drugindustry who have charged that although the FDAapproval times are down, the time from discovery tomarketing continues to lengthen. "If this is true and it istaking longer for a new chemical entity to go fromdiscovery to market, then that is a potentially importantissue that can contribute to the cost of development anddelay a drug from reaching patients who need it."
But Kessler said that he challenged that notion.According to the British Centre for Medicines Research,"there has been no real change in drug development timessince 1980. In its study of 700 drugs that were developedin 20 countries in the years between 1980 and 1994, themean development time ranged up and down between 10and 12 years. In 1994, it was 11.5 years."
The Centre for Medicines Research is a privateorganization in the U.K. that studies the development anduse of medicine with support from the Association of theBritish Pharmaceutical Industry.
The FDA study followed on the heels of a report from theGeneral Accounting Office released in November whichsupports FDA's contentions that review times have fallensince the enactment of the Prescription Drug User FeeAct of 1992. (See BioWorld Today, Nov. 9, 1995, p. 1.) n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.