Legislative Rules on Prescription Drugs Could Limit Innovation, McClellan Says

The combination of high prescription drug development costs and efforts by lawmakers to reduce health care costs could "stifle innovation in the biomedical industry" and reduce the number of new medications that reach the market, FDA Commissioner Dr. Mark McClellan said yesterday, the Contra Costa Times reports. Legislation or regulations to limit financial incentives for pharmaceutical companies could help control health care costs in the short term, but the "combination is not a good one for keeping the United States at the forefront of biomedical innovation," McClellan said at a Commonwealth Club event in San Francisco. He added, "More importantly, it's not a good combination for affordable and high-quality innovative health care for our population." McClellan said that the FDA should implement a more efficient review process for new medications to help reduce prescription drug development costs. In addition, he said that pharmaceutical companies should continue to study new prescription drugs after FDA approval to examine long-term effects. He also said that the FDA plans to use information technology to help reduce medication errors and track new prescription drugs after approval (Silber, Contra Costa Times, 6/10). The FDA in March proposed a rule to require pharmaceutical companies to place bar codes on prescription drugs to help prevent medication errors. The rule would cost pharmaceutical companies about $50 million, and hospitals would likely spend more than $7 billion on bar code scanners and computers. Pharmaceutical companies and hospitals would have three years to comply with the rule, expected to become final by early 2004 (California Healthline, 3/14).

The FDA also will likely to require food companies to include information about ingredients such as trans fats in food labels to help reduce the rate of obesity in the United States, McClellan said. Food companies should focus on "science-based information about the health consequences of their product," McClellan said. An FDA committee will issue recommendations about revisions in food labels later this month (Reuters/Washington Post, 6/10).