Great news..in a vote of 403-16, the House yesterday overwhelmingly passed a historic drug safety overhaul bill. This legislation marks the most significant drug safety reform in 45 years. If you remember, the Senate passed a similar (but not identical bill) in the spring. Here’s what the LA Times Historic Drusays about the two bills:
The House bill follows the same basic approach to safety as the Senate version, but consumer groups said it would give the FDA stronger regulatory powers in some areas.
Both bills would set up a computerized network to scan medical insurance and pharmacy records for patterns that could signal problems with new drugs. The FDA now relies on anecdotal reports submitted by doctors and drug companies, which are believed to capture only a small fraction of bad drug reactions.
A computerized system could take several years to deploy. The Senate bill sets some benchmarks for the FDA; the House version does not.
Both bills would give the FDA additional leverage in dealing with drug companies. This includes greater authority to require that prescribing literature for doctors and patients reflects the latest data on risks, as well as the power to order — not just request — follow-up safety studies.
Such oversight would be carried out through risk management plans tailored to specific drugs. The rules for the risk plans are complex, but policy analyst William Vaughan of Consumers Union said that, overall, the House approach appears to be stronger.
The House bill also includes stiffer fines for drug companies that violate FDA requirements and tighter rules to reduce conflicts of interest among outside scientists who advise the agency.
A House-Senate conference committee will work out differences between the two bills. Congressional leaders say they want to send Bush a final version this summer.
We will be working to get the stronger provisions of the House bill included in the final bill that will be sent to Bush.
This action by Congress is a long time coming. We have been working to pass these kind of reforms for over two years now, with our President, Jim Guest recently testifying to a key House committee on this bill. For years, tens of thousands of our e-activists across the country have written emails, letters to the editor of their local papers, and have made phone calls to Congress. And many people with personal stories of suffering from drug side effects have traveled to meet with lawmakers again and again in an effort to get something done in Washington.