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Executive Summary

Proposals for a product liability FDA approval/government standards defense should be reconsidered in light of GAO's report that more than half of prescription drugs develop serious adverse reactions after approval, House Governmental Operations/Intergovernmental Relations Subcommittee Chairman Weiss (D-N.Y.) suggested May 29. "The mere fact of FDA approval does not mean serious postapproval risks will not occur. Individuals who suffer serious adverse reactions should have the opportunity to hold drug companies fully liable for damages," Weiss asserted. The General Accounting Office report concluded that just over half of prescription drug new chemical entities approved between 1975-1985 were detected after approval as having serious adverse reaction risks (see preceding story). Several days prior to release of the report, the Senate Commerce Committee cleared Sen. Kasten's (R-Wis.) product liability legislation that provides a defense against punitive damages for FDA-approved products ("The Pink Sheet" May 28, T&G-14). Similar legislation has been introduced in the House as HR 2700 by Rep. Luken, but is still pending in the Judiciary and Energy & Commerce Committees. The Weiss subcommittee currently has not scheduled any hearings on the report. However, GAO is continuing with a second phase of the study, as requested by the congressman, to examine whether specific aspects of FDA's drug approval process are linked to development of serious adverse reactions after approval. While GAO characterizes the present report as measuring the extent of postmarketing serious adverse risks rather than critiquing the FDA drug review process, the report suggests some approaches for improving drug review. For example, GAO grouped adverse risks by drug class and disease category, such as renal effects, fetal effects and ophthalmic effects. About "one quarter of the drugs had serious postapproval risks in three or more disease categories," the report says. "There was considerable grouping of the serious postapproval risks by disease category and drug class." Such groupings provide "opportunities to provide FDA reviewers with useful information," the report continues. "For example, reviewers should be better able to estimate the extent of risk for different kinds of patients if they have better knowledge of adverse reactions and disease types for drugs in the same class already on the market." GAO also recommends undertaking more detailed analysis of situations where significant risks detected after approval are more serious manifestations of adverse effects known earlier. "This information can be used to specify the need for more data during the review process or in postapproval research," it states. The report further recommends that FDA "try to estimate the population exposed to the additional risks and assess their significance in terms of expected fatalities and morbidities." "It is disturbing that shortcomings in FDA's approval process may be responsible for serious adverse reactions," Weiss said. "By failing to systematically use evidence of postapproval risks linked to drugs already on the market, FDA may be overlooking problems with similar drugs under review at the agency but not yet approved." He added: "Serious and unanticipated adverse reactions are certainly a risk we must accept when FDA shortens the review time for experimental drugs to treat immediately life-threatening illnesses such as AIDS and cancer. However, for diseases that are not immediately life- threatening, this may be too high a price to pay for shorter approval times." HHS comments, issued as part of the report, were authored by the Inspector General's office. This is somewhat unusual in that the IG is considered the department watchdog, independent of the policy-setting and program administration activities. The IG maintains that GAO's study "is not methodologically sound, does not present a clear objective, is not accurate in many details, does not show insight into new drug development and review, and is very elementary in concept." Despite a summary that "overdramatizes" the report's content, GAO can find "no fault" with any specific features of the drug approval process, HHS says. The Pharmaceutical Manufacturers Association echoed HHS in its own May 29 response. "The drug approval system, out of necessity, relies upon a risk/benefit concept," PMA also stated. "Some of the drugs that have identified risks are the only available treatment, the best available treatment or they are the best second line treatment for filling the gap when other drugs have failed," the association added.

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