What we do know is that there were some rumblings last week on the pre-emption language that’s in the proposal. It was definitely apparent to all who attended the hearing. Congressional Quarterly reported on this today:
A House panel will mark up a draft Food and Drug Administration overhaul bill Tuesday, having resolved differences that delayed action on the measure last week.
Republican objections to language that would have forbidden federal pre-emption of state drug-safety and device-safety laws and regulations prompted a postponement of a June 14 markup by the Energy and Commerce Health Subcommittee.
Stakeholders, including medical-device makers, had called the language a deal-breaker for the FDA bill.
According to a GOP aide and several lobbyists on all sides of the issue, an agreement was reached on the pre-emption language that satisfied Republican concerns.
What is the controversy over all about: Well, the FDA, without allowing the public to comment and without clear authority recently added a note (a gift to the industry) in a preamble to a regulation that it believed its approval of a drug pre-empted a range of state tort actions. This note, if approved by the courts, would effectively prevent consumers from holding drug companies accountable.
Why this makes no sense: Vioxx, Paxil, Avandia, Ketek…should I go on? The FDA has a poor track record in protecting the public against dangerous medications on the market. With our drug safety system in shambles, consumers harmed by a medication deserve the right to take action through the Courts. And Pallone’s proposal basically states that this preemption does not exist (rightly so).
We’ll see how this will all shake out this week, will give updates as soon as we know more.