NEW DEMOCRATIC CONGRESSIONAL LEADERS TO FOCUS ON DRUG SAFETY, MEDICARE REFORM
With the Democrats taking control of the House of Representatives for the first time since 1994, the healthcare agenda will now be in the hands of some very vocal critics of HHS policy regarding drug safety and effectiveness, FDA oversight and drug prices, particularly in Medicare.
Based on seniority in key House committees, it appears that agency critics such as Reps. John Dingell (D-Mich.), Henry Waxman (D-Calif.) and Rosa DeLauro (D-Conn.) will shape healthcare policy during the 110th Congress. These lawmakers are all the ranking members in committees that have jurisdiction over healthcare and are in line to take over as chairmen. Dingell will likely chair the House Energy and Commerce Committee, with Waxman chairing the Government Reform Committee and DeLauro the appropriations subcommittee that funds the FDA.
Dingell is planning to focus on improving FDA oversight of drug safety, lowering Medicare costs and easing the path for generics to be introduced into the market. Drug safety is "one of the things we will have to take a look at," he said during a Nov. 8 conference call announcing his agenda. Not only does Dingell want additional oversight of drug companies by the FDA, but also he wants the agency and the Department of Justice to focus on dietary supplements.
Dietary supplements have been the alleged cause of numerous deaths, Dingell said. The problem is so serious that he may request criminal sanctions against the manufacturers.
Dingell is also planning to address potential obstacles for generics. Brand pharmaceutical companies have misused patent law and drug licensing requirements to keep generics out of the marketplace, he claimed. For example, Dingell has been concerned with the practice of reverse payments, where a brand companies pays a generic competitor to delay launching its version of a drug. Many times, "generic drugs have been held off the market by agreements between manufacturers," he said.
Waxman and DeLauro have also focused on drug safety and generics, introducing numerous bills on these topics while in the minority. Earlier in the year, DeLauro targeted the midterm elections as an opportunity to make major changes to healthcare policy. "We recognize that FDA's gold standard has been tarnished, with deadly consequences for thousands of families," DeLauro said during a June press conference. "At the top, quite frankly, we can't get anywhere," DeLauro said at the time. "In my view, we do have to change leadership in the House."