VIEWS & REVIEWS

us drug approval system due for a revamp?

There are murmurings in the US that it is time to devise a 'n4!'w, more responsive system ' for considering applications for marketing approval for new drugs and medical devices, according to Bob Gatty writing in Hospital Formulary.

The Progress and Freedom Foundation. which has backing from certain pharmaceutical companies. is one group calling for such reform. The foundation is keen to see the private sector have more input into the approval process, with the government playing moce of an oversight role. One idea is to have new drug and medical device applications reviewed by an independent private sector body such as Underwriters Laboratories.

Dr lean Paul Gagnon from Marion Merrell Dow believes that there is a lot of expertise within the pharmaceutical industry that could be used to increase the efficiency of the drug approval system. However, appropriate safeguards would need to be put in place to ensure against conflicts of interest. Dr Gagnon supports the idea of a conson..ium involving experts from the pharmaceutical industry, academia and government.

The FDA, as set up at present, is restricted by too many rules and regulations, says Dr Gagnon. The agency also has no vested interest in speeding up the drug approval process . Thls combined with an overwhelnting work.1oad and understaffing means that it is not a very efficient system, according to Dr Gagnon. Staffing problem are being addressed, but the changes may not be sufficient to satisfy critics of the FDA, concludes Bob Gatty. Gaily B. Who would IppI'O"C' DCW Ih,. it~ were noFOA? Il00pital

formulary 30: 51. Ju 1995 _,""

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