House member Waxman introduced a great bill two months ago that goes further than the Senate bill just passed last week. For instance, his bill would put a 3-year moratorium on ads for drugs with serious safety risks, would require a warning symbol on the packaging of all new drugs for two years, and would require disclosure of Phase II-IV results of clinical trials (the Senate bill would require Phase III and IV and their language is a bit murky)
It looks like the House will address drug safety after Memorial break. Then, we expect the House Energy and Commerce committee to vote legislation out of committee and then it will go to the House floor. This committee has already had a few hearings on drug safety.
Our hope is that no backdoor deals (or no deals at all) are made which may weaken the bill. Pressure will be strong coming from the drug industry to water down any reform as much as possible. The House should listen to its constituents on this. We conducted a telephone poll two months ago that asked over 1,000 people their opinions on drug safety. The results?
96 percent agree that the government should have the power to require warning labels if safety problems are identified – with 80 percent of those “strongly agreeing” to that authority. Right now, the Food and Drug Administration must negotiate safety warning labels with a drug maker.
93 percent agree that the FDA should have the power to order follow-up safety studies, with 65 percent “strongly agreeing” to that authority. Today, the FDA generally does not have the authority to require safety studies be performed once a drug is on the market.
92 percent of Americans agree that pharmaceutical companies should make public the results of all of their clinical trial studies, which reveal a drug’s effectiveness as well as possible hazardous side effects. Of those, 68 percent “strongly agreed” that drug studies should be made public.
We have only a few weeks to do whatever we can to up the pressure on the House. Everyone should email or call their House members asap, and ask them to support HR 1561, sponsored by House members Waxman & Markey.
And let’s share any feedback you all get from your House member’s office, we’ll be working to keep tabs on where each member stands.