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Task Force Meeting: View from The Hill, part 2

Steven Irizarry, JD, Vice President of Government Relations of ML Strategies, LLC, former Senior Health Counsel to the Senate Special Committee on Aging, and former counsel to the Senate Health Education Labor Pensions (HELP) Committee, predicted at the National Task Force on CME Provider/Industry Collaboration conference that 2007 will be a big year for healthcare legislation. For example, he said the reauthorization of the Prescription Drug User Fee Act is "considered must-pass legislation, as is the Best Pharmaceuticals for Children's Act." He called these two pieces of legislation "locomotives," or bills that have the energy and support to move on their own, as opposed to "boxcar" bills, which need to be hooked into a locomotive to get passed. There also are two competing bills related to drug trail results disclosure, the Fair Access to Clinical Trials Act, introduced by Sen.s Grassley and Dodd; and the Enhancing Drug Safety and Innovation Act of 2006, introduced by Sen.s Kennedy and Enzi. "While these two competing bills are quite different, they both contain key things about off-label issues," he said.

The November elections could affect future healthcare legislation, he said. "Democrats have been more critical of the FDA and pharma. They won't provide less scrutiny of the pharmaceutical industry." His advice? "Get involved. Educate members of Congress and their staff, because they have no idea what CME is and what you do. If you don't h ave a voice, no one will speak for you, or if they do, you may not like what they say."

He also talked about possible new legal actions:

  • A push from Congress to have OIG and DOJ do more investigations on rewarding reimbursables under Medicare and Medicaid. "This could have a chilling effect on grants," he said.

  • Legislation that would require greater disclosure. "This is very practical, and it's on the mind of Congress. Instead of restricting grants, require more transparency and disclosure."

  • Changed to the Food, Drug, and Cosmetics Act that would entail more restrictions.
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