So, the long awaited House drug safety draft is out and I think patient groups (not those PhRMA front groups of course) will be pretty psyched about it. The House member that put out this proposal, Rep. Pallone, is the chair of the Health subcommittee of Energy and Commerce.
So, what’s this proposal all about? Some parts of it are stronger than what the Senate passed. First it would require all new drugs to have a warning symbol on their label, to alert the public that some dangerous side effects of the medication may not be known. This is something that the Institute of Medicine recommended in their report that came out last year. It would also allow the FDA to enforce a temporary advertising moratorium for drugs with serious safety risks. (this will be fought tooth and nail by companies that can’t wait to further drive up the cost of health care by pushing out ads for pricey hair loss medications).
And like the bill the Senate passed, it would give the FDA more authority to require follow up safety studies and to change a drug’s label, and the proposal would match the Senate’s additional funding for safety.
All great stuff, but how could this proposal really shake up our broken system?..if it gave more authority to the Office of Drug Safety. If the recent Avandia controversy doesn’t show why this is critical, I don’t know what does. An amendment to the Senate bill that would have done this lost by one vote..pretty heart breaking…but this will hopefully push the House to include this reform.
Next week we also expect a committee vote on this proposal. Fingers crossed that our drug safety champs in the House will hold the line on this one, and will drown out industry lobbyists, who will fight to whittle this bill down to something the public will yawn at.