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An entirely new leadership structure in the House and the Senate is coming as Democrats took both houses of Congress during the midterm elections. Read More
For the first time in 12 years, Democrats will control both chambers of Congress, and the new leadership includes many vocal critics of agency policy. These lawmakers and many of their colleagues are likely to push for improved handling of drug reviews by the agency, a clearer path for getting generics to market and direct government Medicare negotiation, among other changes. The new congressional agenda is believed to be leading to an upheaval in healthcare policy or complete gridlock, depending on the observer. However, one thing experts across the board agree on is that things will be very different than they have been under Republican leadership. For example, increased oversight will be a hallmark of the 110th Congress, placing the FDA and industry under greater pressure from lawmakers than they have faced in many years, and both are already making preemptive moves to head off upcoming legislation. But whether real change occurs depends on many factors, including the heightened role of conservative Democrats in the House. This issue of The Food & Drug Letter looks at what the next year may be like on Capitol Hill.Read More
President Bush's nomination of Andrew von Eschenbach to be the next FDA commissioner is at a stalemate as the agency and Sen. Chuck Grassley (R-Iowa) battle over access to information from an ongoing clinical trial investigation, an FDA source says. Read More
With the new year approaching and a new Congress ready to
be seated, the device industry is preparing to lobby for its FDA and Medicare priorities, AdvaMed President and CEO Stephen Ubl told D&DL. Read More
With Democrats taking control of the House of Representatives for the first time since 1994 and the Senate for the first time since 2001, the healthcare agenda will now be in the hands of members who have been critical of HHS and FDA policy in the past, meaning changes for the FDA and industry may be on the way.
Patent reform bills pending in the House and Senate would enact sweeping changes to existing patent laws to the detriment of generic drug companies if passed by Congress, one legal expert said at a recent industry conference.
Five Democratic lawmakers have asked HHS to give them an update on the agency’s investigation into former FDA Commissioner Lester Crawford’s “sudden” resignation from the FDA one year ago.
Congress is debating whether to amend a consumer-protection law to keep contact lens makers from shutting internet-only sellers out of the distribution loop.
An FDA employee who has publicly criticized the agency for not doing more to protect the public against the cardiovascular health risks associated with Vioxx is calling for patients to take naproxen instead of Cox-2 drugs and is urging the agency to reject Merck’s Vioxx successor Arcoxia, in an editorial recently published in the Journal of the American Medical Association (JAMA).
The Congressional Budget Office (CBO) estimates, in a Sept. 12 paper, that the “Dietary Supplement and Nonprescription Drug Consumer Protection Act” will cost the federal government $3 million in 2007 and $50 million from 2007 to 2011 if it becomes law.