SEATTLE -- Pledging his agency's efforts to find solutions, notproblems, the director of the Food and Drug Administration'sOffice of Biotechnology has outlined recent moves toaccommodate more biotechnology product applications.
In appearances before industry meetings here last week, HenryI. Miller said, "We will be at the front line, probing for andproviding solutions." The agency would not block "the horn ofplenty that is being created by the new technology."
The FDA, he said, is working toward a more efficient drug-review system by reallocating resources, creating new reviewdivisions to tackle emerging product classes like cytokines andappointing an advisory committee for biological responsemodifiers.
Biotechnology products have on average clocked faster reviewtimes through the FDA than conventional drugs and otherproducts, he noted. "But we can and will do better," said Miller,a medical doctor who worked in the early 1980s on FDAreviews of genetically engineered drugs.
Toward that end, he noted that the FDA:
-- Announced last April an "accelerated approval" process forreviewing breakthrough drugs that will allow developers togather certain confirmation data on a drug's effectiveness afterthe product is approved for marketing.
-- Started an external review program that allows the agencyto use qualified non-government experts to handle someroutine applications. While biotechnology drugs will notinitially be included, the effort should help shorten overallreview times, Miller said.
-- Plans a research center for food biotechnology, called theMoffett Center, to be run in cooperation with the IllinoisInstitute of Technology.
-- Hired additional research and review staff as part of a 15percent, or 50-person, staff increase announced last March towork exclusively on biotechnology products in its Center forBiologics Evaluation and Research (CBER).
-- Plans to soon reorganize CBER under newly appointedDirector Kathryn Zoon to improve the review process and itsintegration with research functions, and to delegate authorityand responsibility through the staff.
Details of the CBER reorganization have not yet beenannounced, "but I can assure you that much of it will be drivenby our need to accommodate the rapidly growing number ofbiotech product submissions," Miller said.
The agency's scoreboard in biotechnology-derived productsshows approvals of 16 therapeutics and vaccines and morethan 650 diagnostic kits plus two food ingredients that the FDAconcluded were generally recognized as safe, he said. The FDA'sCBER is keeping tabs on 1,200 clinical trials involving biologics.
In a widely reported proposal last May, the FDA suggested thatbiotechnology foods be regulated like conventional foods. Thatis, the level of regulatory review for new foods will beconsidered under the adulteration provisions of the FDA act,Miller said.
Under the proposed rule, which is open to public commentthrough mid-October, pre-market review would not berequired for most biotechnology-derived foods -- thosecomposed of new plant varieties that are the same orsubstantially similar to those found in conventional foods, hesaid. Products containing a completely new food substance orthat show the presence of an allergic compound or increasedtoxic levels would prompt close scrutiny and, if approved,possibly special labelling.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.