Proposed Improvements in New Drug Approval Procedures

The costs of new antirheumatic drug development in the United States have risen dramatically and development time has slowed in the past 2 decades. In 1980 the mean development cost per drug was $70 million and the development time was 10 years, compared with $2 million per drug and a 2-year development period in 1962. Not only does the delay in approval increase the consumer expense and deny patients possibly benefical treatments, but it also discourages industrial research and development into potentially effective drugs with a limited market, since the delays significantly shorten the patent-protected life of the drug.

The release of new drugs is materially delayed in the US by comparison with the UK and yet there is not a significantly greater incidence of adverse drug reactions or withdrawals in the UK. The Food and Drug Administration (FDA) has attempted to improve the situation by providing tax incentives for drugs targeted tor small, marginally profitable markets and by instituting fast track drug approval on the basis of unique features ot a particular drug.

At a recent workshop, requested by the FDA and sponsored by the American Society of Clinical Pharmacology and Therapeutics, several changes to the current procedure of new drug approval were proposed to remedy these problems: • modification of the FDA from a purely regulatory agency to include an additional function as a fellow

scientific body with peer review of regulatory decisions and disputes • extension of the patent period for new drugs from 17 to 25 years • limited release of new drugs, with elimination of time-consuming, redundant trials and applications not

specific to the limited range of drugs • replacement of placebo trials with well designed double-blind comparisons with existing drugs of proven

efficacy. These studies to be performed 2 times in patients with rheumatoid arthritis and once in each major disease subgroup, progressively. These steps should provide a faster, more effective process ' ••. consistent with the goals of all committed

participants from Industry, the FDA and scientific Investigators.' Roth. SH and Mackenzie. A . Annals of Internal Medicine 101. 125 (Jut 1984)

0756-2703/ 84/ 0877-0003/ 0$07.00/ 0 ("s) ADfS Press INPHARMA~ 4 Aug 7984 3