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Executive Summary

BIOTECH FIRMS INCREASING BUSINESS THROUGH EXPORTS of products currently unapproved in the U.S. market, Center for Biologics Evaluation and Research Consumer Safety Officer Fred Rangel indicated at a July 14 session of a Food & Drug Law Institute update on the biologics industry. Rangel said his Inspection and Surveillance Division within the Compliance Office is projecting "a 200-fold increase in the number of firms competing in foreign markets." The number of export applications FDA reviews has been increasing along with the number of small companies seeking to export unapproved biologics. Export applications are up 28% through the first half of fiscal 1992, Rangel said. FDA received 66 applications to export unapproved biologic products in FY 1990 and 77 applications the following year, Rangel said. The agency denied only one application in the period 1988-1992, but 11 applications have been withdrawn this year. The Center for Drug Evaluation and Research and CBER are proposing a process for approving within 30 days applications to export products for clinical investigations overseas, Rangel said. After meeting with the Pharmaceutical Manufacturers Association, the centers have developed a proposal for companies that export products for foreign studies, Rangel explained. Under the proposal, applications "will be submitted much more rapidly, will get approval much faster," and companies "will be able to start their clinical studies within less than 30 days." In a May 22 letter to PMA Senior VP-International Division Harvey Bale, FDA Deputy Commissioner for Policy Michael Taylor explained the proposal. As under current policy, firms that wish to export drugs for testing may submit letters from the foreign health authority affirming that the drug can be used legally there. Under the proposal, firms instead may submit a copy of a letter to the foreign authority outlining the proposed trial and asking the foreign agency to respond within 30 days to the firm and FDA. In addition, a certification must be submitted that the drug can be used legally in the foreign country for the stated purposes. Joseph Salewski, Bioresearch Monitoring Branch chief within CBER's Compliance Office, told FDLI that 27% of adverse findings during FDA inspections of clinical investigations of biologics and biotechnology firms involve problems with institutional review board clearance of studies. Salewski reported that 22% of inspectors' findings involve inaccurate case histories or case report forms, 20% involve noncompliance with study protocols and 14% involve problems with accountability of the test article. Several other factors account for 1% or less of inspectional findings.

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