Washington Report - Pharmaceutical Executive

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Washington Report
News stories on health policy developments from the Hill and their effect on the pharmaceutical industry

Washington Report: Hard Evidence

July 1, 2006

Pharma companies fear CMS' new Medicare policy will routinely require post-approval studies in order to gain reimbursement for new drugs. CMS says it is expanding payment for "promising but not persuasive" drugs.

Washington Report: Promises to Keep

June 1, 2006

Pharma follow-through? As of September 2005, drug manufacturers had promised to perform 1,200 post-marketing studies. Companies hadn't even started 65 percent of them, and only 200 were completed.

Washington Report: Opportunity Knocks

May 1, 2006

The pharmaceutical companies in the Predictive Safety Consortium have agreed to cross-test each other's laboratory methods to determine which are most effective in detecting kidney, muscle, and liver toxicity.

Washington Report: A Warning Trend

April 1, 2006

FDA doesn't usually write a black box warning "without some pretty good data," said Robert Temple of FDA's Office of Medical Policy. Overuse of the black box can both dilute its impact and limit access to needed treatment.

Washington Report: Labels and Liability

March 1, 2006

Pharmaceutical companies are worried that FDA's new labeling format will expose them to liability suits from individuals who suffer adverse events that are not highlighted, but "hidden" in the full prescribing information.

Washington Report: Cross-Agency Collaboration for Part D

February 1, 2006

While CMS officials praise the CED policy as a way to extend Medicare coverage, patients and industry fear the agency won't reimburse for innovative treatments unless sponsors support post-approval studies.

Washington Report: PDUFA Blues

January 1, 2006

FDA wants flexibility to use user-fee revenues to extend drug safety oversight, to review direct-to-consumer advertising before it goes public, and to modernize the ever longer and more complex drug development process.

Washington Report: Big Production

December 1, 2005

FDA may be receiving fewer new drug applications for truly innovative products, but it has been overwhelmed this year with 800 abbreviated NDAs for generic drugs and thousands of supplements.

Washington Report: Out of Commission? Crawford Steps Down

November 1, 2005

The circumstances of Crawford's departure may complicate the process of securing a permanent FDA leader. Congress and HHS are investigating whether his confirmation process failed to uncover important facts.

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