House Caves to Pharma

The House Energy and Commerce subcommittee on health this morning dropped two controversial elements from the Food and Drug Administration reform bill. In the original bill, every new drug approved by the agency would be required to have a risk evaluation and mitigation strategy (REMS) for monitoring their use the first few years on the market. The drug industry succeeded in leaving those decisions to the FDA's discretion -- with all the susceptibilities to industry pressure that implies.

Also, a three-year-waiting period before direct-to-consumer advertising can begin was also dropped. Again, the bill simply gives the agency the power to impose such a temporary ban if it wants, something it has never done.

The House bill also contains a conflict of interest clause that will allow the FDA to continue appointing one scientist with ties to industry to each advisory panel. This is better than the Senate bill, and better than the proposed guidance by the FDA, which would grant unlimited waivers but allow conflicted scientists to participate in the meetings without a vote. But it's not a total ban on conflicts of interest, which would have sent a clear message that the FDA's days of cozying up to the drug industry are over.

While there are many improvements in the legislation that will be marked up by the full committee on Thursday -- especially the clinical trials results database -- this morning's actions represent a big win for Big Pharma.