A federal advisory group says government complicity in the suppression of certain pharmaceutical industry "trade secrets" may endanger human life through "wasteful and unjustifiably duplicative" clinical testing of new medicines.
The Review Panel on New Drug Regulations was created by the Department of Health, Education and Welfare in February, 1975, to review the Food and Drug Administration's regulation of the marketing of new drugs. Headed by New York University law professor Norman Dorsen, the panel is scheduled to complete its work by March 31.
The FDA policy on trade secrets, which prevents it from releasing scientific studies done by manufacturers on the safety and effectiveness of medicines, came under attack in an interim report by the panel to HEW Secretary David Matthews last Nov. 15. He authorized release of the report a few days ago without comment.
The FDA trade-secrets policy has long been questioned. In the early 1960s, for example, a former official of the Council American Medical Association's Council on Drugs protested that the policy can result in drug tests causing death or illnesses that could have been prevented if a company had not been kept in the dark about the findings of another's tests.
Over the years, senior FDA officials also have expressed concern about the policy, but have insisted that their hands are tied by law unless Congress changes it.
The panel did not fully endorse this view, saying "FDA's legal ability to alter its trade-secrets policy is unlcear." It agreed that the case for congressional action is "overwhelming and urgent."
In addition to inducing redundant clinical testing, the suppression of data on safety and effectiveness "also interferes with the free exchange of scientific knowledge, fosters inefficiencies in the drug approval process, and adversely affects the competitive structure of the drug market," the interim report said.
"Moreover, it undermines the possibility of ensuring that public health decisions are based upon facts and considerations that are open to public scrutiny," the report added. It continued:
"The sole justification for this trade secrets policy is that it may protect the market position, and thus the incentive to innovate, of companies that invest in research and development of new drugs. The panel concludes that the incentive to innovation can be retained without sacrificing the benefits of a policy of open disclosure."