The Senate recently approved a drug safety bill which will double the number of government scientists assigned to find risky side effects in medicines that are already on the market in the United States. The bill will also create a computerized network to scan medical insurance and pharmacy records for signs of trouble with new drugs, and it will greatly increase the power of the Food and Drug Administration to require drug makers to reduce risks.
This drug safety bill was drafted due to the safety lapses of late, including the withdrawal of Vioxx and Rezulin, as well as the FDA’s late warning regarding suicide risks with antidepressants. It also addresses consumer complaints about misleading marketing of drugs. The FDA will now have a voluntary program which will review television commercials before they are aired.
The House is expected to come up with its own drug safety bill soon. The House bill is likely to be harder on the industry, but senior House lawmakers have praised the Senate’s basic attempt. They are hoping to have a bill to President Bush this summer.
Highlights from the Senate’s bill include:
– A computerized system to monitor potential problems with new drugs.
– Strengthens FDA powers to require follow-up safety studies and stronger warnings for medications already on the market.
– Significant increases in funding and staff for the FDA drug safety office.
– Expanded public disclosure of clinical trials and their results.
– FDA required to release dissenting opinions of agency scientists.
– Stricter conflict-of-interest rules for the FDA’s outside advisors.