LA Times reports on the Senate passage of a bill that should enhance
the oversight of drug safety by the FDA. Numerous posts here
on ScienceBlogs, and elsewhere, have commented on the problems with
safety oversight. The existence of these problems has been no
secret since the Vioxx problem came to light a few years ago.
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?
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
of the HPV vaccine, and see how effectively it prevents
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.