HURRICANE WILL LIKELY DELAY RX INITIATIVES
The pharmaceutical agenda on Capitol Hill will likely be delayed this fall as lawmakers focus their attention on Hurricane Katrina recovery efforts and filling U.S. Supreme Court vacancies, sources say.
Congress has yet to address a full plate of bills affecting the pharmaceutical industry, including proposals to reform the FDA's drug-safety oversight duties, require postings to clinical trial registries, legalize prescription drug importation and revamp the medical malpractice system by shielding drugmakers from punitive damages on products that adhered to FDA standards for approval.
The pharmaceutical agenda before the Senate Health, Education, Labor, and Pensions (HELP) Committee has slowed down, in light of Hurricane Katrina, said committee spokesman Craig Orfield. "I don't know, in a true sense, how much of a drag this is going to create on other legislation proceedings," he told FDAnews. "But obviously there is going to be a little additional time added, because of the need to address the disaster in the Gulf Coast."
Prior to the hurricane, HELP Committee Chairman Michael Enzi (R-Wyo.) planned to address various pharmaceutical safety and FDA reform issues this fall, Orfield said. "I don't think anyone believes these items are off the table for this year," he said. "We're not raising a white flag. But obviously, the element of time is diminishing here."
PhRMA also recognizes that Congress' priorities may lie elsewhere this fall. "That's as it should be," said PhRMA spokesman Jeff Trewhitt. "The top, overriding priority for PhRMA and its members this fall is making sure that the victims of Hurricane Katrina receive the medical supplies, medicines and other supplies they need," he told FDAnews.
To the extent that other legislative issues are addressed, PhRMA's priorities remain the same, Trewhitt said. The trade group remains focused on the "efficient and punctual" implementation of drug coverage under Medicare; reforms to the Medicaid program that ensure beneficiaries continue to have access to the medicines they need; a "responsible approach" to drug-safety reform; and an emphasis on drug access and affordability proposals that are "safe for patients and make sense," he said.