In many ways, this resembles the Senate bill, although there are also tougher provisions. Still, the lack of an independent safety office is likely to upset people who argue the current FDA bureaucracy inhibits staffers from pursuing safety issues. The political will, however, doesn’t seem to exist to fund a new entity or pursue Sen. Chuck Grassley’s idea, which is to empower an existing FDA office that already has similar responsibilities.

Here’s what the House bill, which will be discussed next Tuesday at a scheduled PDUFA hearing, does contain:

· $225 million more in user fees;
· a requirement that all new drugs display a symbol;
· a requirement that new drugs undergo risk evaluation;
· limits on DTC ads for drugs with severe or unusual side effects;
· grants only one conflict-of-interest waiver per advisory panel;

The House bill also permits the FDA to impose fines for not complying with safety rules, such as conducting post-marketing studies or posting trial resuts. Drugmakers would have to pay a percentage of a drug’s profits.

To read the legislation, click here and here. To read about panel conflicts, look here. Look here for clinical trials. There’s more. Keep reading….

Look here for the section on pediatric exclusivity, and you can read about devices here.

In a nod to complaints that the FDA and pharma negotiated the user fee issue in secrecy, the House bill calls for including consumer and patient advocates to participate in negotiations between the drug industry and the FDA on the next user fee proposal, slated for 2012.

There are also guidelines for registering and reporting clinical trials, and making available to the public. The Senate bill calls for a 30-month study and rulemaking for guidelines.

Bill Vaughan, senior policy analyst at Consumers Union, says that group is, overall, “happy” with the bill, given that few semed to expect Congress to back a separate office of drug safety. “The bill does help ensure there’s more information about drug risks, and that’s important. We need more information to better choices about drugs and health care, in general.”