Full article reprinted from "The Pink Sheet" January 6, 2009
Find out why Drug companies likely will face less combative investigations into their activities by the House Oversight and Government Reform Committee during the 111 Congress.
Full article reprinted from "The Pink Sheet" January 6, 2009
New House Oversight Panel Chair Towns Less Combative With Drug Industry
Drug companies likely will face less combative investigations into their activities by the House Oversight and Government Reform Committee during the 111 Congress.
With the departure of current chairman Rep. Henry Waxman, D-Calif., to lead the House Energy and Commerce Committee, the oversight committee will be headed by Rep. Edolphus Towns.
The New York Democrat has indicated a willingness to cooperate with industry, co-sponsoring an amendment with Rep. Steve Buyer, R-Ind., that eliminated a moratorium on direct-to-consumer advertising from FDA reform legislation last year.
But the law does not let industry entirely off the hook - it now gives the agency authority to fine sponsors for false and misleading commercials.
That vote was a setback for moratorium supporters, including Waxman and Sen. Edward Kennedy, D-Mass., and Waxman now seems poised to make another run at DTC restrictions this year.
Minority Participation In Clinical Trials
Towns' more cooperative style can be seen in his approach to an area where he would like to see changes in the behavior of drug companies - participation of minorities in clinical trials.
Towns has voiced concern about the declining rate of minority enrollment in drug testing. But rather than just railing about industry's failures in this area, he has floated the idea of a minority exclusivity period to create an incentive to enrich trials with broader populations.
Similar to the incentive provided for pediatric trials, this option would grant drugs a marketing exclusivity period if trials are completed for a drug's effectiveness and safety in minorities.
Over the years Towns also has co-sponsored other legislation to ensure protection of participants in clinical trials.
A 26-year veteran of the committee, Towns said in a statement following his Dec. 10 election to the chairmanship by the House Democratic Caucus that he wants to work with the Obama administration "to ensure the federal government is transparent, responsive and efficient."
His work as chairman of the Oversight Subcommittee on Government Management, Organization and Procurement provides the background for that effort, as his focus has been on federal agency operations and federal contractors.
One topic reviewed by the subcommittee was health information technology and the need to ensure interoperability of state, local and community initiatives in this area and to avoid duplicative efforts and spending. Health IT is a means of reducing health disparities in underserved communities, according to Towns.
Staffing Up For Investigations
He has not yet set an agenda for the full committee next year, so it remains unclear how prominent health care issues will be. At the moment, Towns is concentrating on staffing so the panel can execute an aggressive oversight and reform function, an aide said.
Toward that end, Towns has selected two lawyers with oversight experience to lead the committee's majority staff next year.
Ronald Stroman joins the panel as staff director after a seven-year stint as a managing director at the Government Accountability Office, the investigative arm of Congress.
He is no stranger to the committee, having served in various staff positions from 1988 to 1997.
Michael McCarthy, staff director and chief counsel to Towns' government management subcommittee, is moving to the full committee as deputy staff director.
- Cathy Dombrowski
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