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Commentary

How to Improve Drug Safety
William B. Schultz, Washington Post, 12-2-04

Many of Mr. Schultzís recommendations are sensible enough in theory, for instance expanding the FDAís authority and access to postmarketing information on drug use and the frequency of side-effects. However, once we shift to an information driven system of postmarketing drug surveillance, we should limit pharmaceutical liability in a similar manner to the program in place at the National Vaccine Injury Compensation Program.

Timely reporting of adverse effects and better information for clinicians and payors would improve the quality of the system, but at the risk of an explosion of liability suits against manufacturers and slowdown in patient access to new medicines. We can overcome this problem by shielding companies from tort liability and creating a program with a set schedule of compensation for injuries that only come to light once a drug is already on market. This would help physicians keep drugs away from high risk payments, allow insurers and the government to target payments at the most effective treatments, and give incentives to companies that continually study and monitor the use of their treatments after FDA approval.



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