 |
 |
 |
|
|
Home Page >>
News Articles >> Avandia heart attack panic pushes Feds t..
Avandia heart attack panic pushes Feds to reform the FDA
|
| September 24, 2007. By Brenda Frohloff |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Washington, DC: Just four months after diabetics and their doctors were rudely awakened to the dangers of taking Avandia, Congress passed legislation Sept. 20 boosting the power of the Food and Drug Administration (FDA).
The new legislation, aimed at transforming the FDA from a passive watchdog into an active hunter for dangerous prescription drugs, received overwhelming approval from U.S. lawmakers. The swift passage of the legislation was a reaction to the "last straw"--the FDA fiasco over reporting and reacting to the heart attack and heart disease risks connected with GlaxoSmithKline's (GSK) diabetes drug Avandia.
An online analysis of the results of 44 clinical trials, published May 21 by the New England Journal of Medicine, showed that diabetics taking Avandia had an increased risk of heart disease, and in particular, their risk of heart attack increased by 43 percent. In the furor which followed, both GSK and the FDA came under fire for not disclosing these risks earlier. The FDA's reaction seemed flabby, and the whole affair quickly came up for scrutiny before a House committee.
The FDA in the end didn't ban Avandia, settling instead for a Black Box (highest level) warning on the drug.
But the whole thing made a lot of people uneasy, and made it easier for the reform legislation to pass.
The new legislation will strengthen the FDA in the following ways:
- Instead of waiting passively for reports of adverse reactions to drugs it has approved, the FDA will establish its own computerized database, and will be allowed to scan pharmacy and insurance databases for patterns of problems with medications. The FDA database is to include 25 million patients by 2010, and 100 million patients by 2012. This is a huge improvement over the current situation, where the FDA waits for others, including reluctant drug makers, to advise it of drug problems.
- The legislature boosts by one-third (from $305.5 million this year to $417.8 million next year) the revenue the FDA will receive from companies seeking speedy approval of their products--giving the FDA much needed money to employ more staff for research and enforcement.
- Drug makers will have to disclose to the FDA results of all clinical trials conducted, not just those that put their products in a good light.
- The FDA will be able to force drug companies to put necessary warnings on drug packaging, rather than having to negotiate with the manufacturers for this to be done.
- Companies that violate FDA orders on labeling or drug studies could face fines of up to $250,000 for a single violation, and $10 million for multiple violations.
- New advisory panel rules will bring about a gradual reduction in the participation of members with conflicts of interest.
So, in the end, something good came out of the 2007 Avandia scandal. The new legislation doesn't make life any easier for the diabetics who have been harmed by Avandia, but it is something good
Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
Search 10,000 recent
cases and settlements
Lawsuits:
Services:
© 2001-2008 Online Legal Marketing Ltd. All rights reserved.
