Senate passes sweeping drug-safety bill
The FDA's powers and staff would be enlarged to more quickly scan the marketplace for risky medications.
By Ricardo Alonso-Zaldivar, Times Staff Writer
May 10, 2007
WASHINGTON — The Senate overwhelmingly approved a landmark drug safety bill Wednesday, doubling the number of government scientists assigned to ferret out risky side effects in medicines already on the market...
...The House is expected to write its own version of the legislation soon. Its approach is likely to be tougher on industry, but senior House lawmakers have praised the Senate's basic approach. They say they hope to get a bill to President Bush by summer.
What does the bill do?
It
doubles the size of the FDA's drug safety division. It
increases the budget. It calls for mining of prescription
drug usage data to try to find patterns that could suggest a causal
association between drugs and disease. Those are good things.
What does the bill sort-of do? It gives the FDA more power to order safety studies. That could be good, but I have my doubts about how effective it will be. It gives the FDA more power to force companies to put warnings on their drugs, and to change the prescribing instructions. That could be good, but there are many instances in which such warnings and instructions have not been followed. So those provisions are wishy-washy things.
What does the bill not do? It does not separate the process of monitoring drug safety into a separate agency, and it does not reduce the reliance on user fees for funding of safety monitoring. Those are not good things.
How well will this all work out? We'll see in a few years. Looks like one of their first projects will be to monitor the safety of the HPV vaccine, and see how effectively it prevents cancer.
Although not perfect, the bill is a step in the right direction, and they want to get this through the House and on to the President's desk soon. If they tried to make a perfect bill, it would get bogged down in partisan bickering, the user fee act would expire, and the whole operation would grind to a halt.
What does the bill sort-of do? It gives the FDA more power to order safety studies. That could be good, but I have my doubts about how effective it will be. It gives the FDA more power to force companies to put warnings on their drugs, and to change the prescribing instructions. That could be good, but there are many instances in which such warnings and instructions have not been followed. So those provisions are wishy-washy things.
What does the bill not do? It does not separate the process of monitoring drug safety into a separate agency, and it does not reduce the reliance on user fees for funding of safety monitoring. Those are not good things.
How well will this all work out? We'll see in a few years. Looks like one of their first projects will be to monitor the safety of the HPV vaccine, and see how effectively it prevents cancer.
Although not perfect, the bill is a step in the right direction, and they want to get this through the House and on to the President's desk soon. If they tried to make a perfect bill, it would get bogged down in partisan bickering, the user fee act would expire, and the whole operation would grind to a halt.
Comments
Assume that all the high ranking people in the FDA will retire to take high paying jobs in the industry. Now, what do you think will really happen?
Posted by: Gork | May 13, 2007 7:48 PM
What will really happen? It will get worse before it gets better. I hope that the House can get them to extend the user fee act for just a few more years, just like extending the Iraq war a few more months. It will bring the debate up again fairly soon, and by then there will have been a few more disasters; it will be easier to make a case for tighter restrictions, and more oversight.
Posted by: Joseph j7uy5 | May 13, 2007 8:08 PM