By Lisa Richwine and Susan Heavey
NEW YORK (Reuters) - Drug makers are calling for steady leadership, political independence and a boost in funding to improve the climate at the U.S. Food and Drug Administration under President-elect Barack Obama.
The FDA has suffered with high turnover at the top post during President George W. Bush's eight years in office, pharmaceutical industry executives told Reuters this week.
Some criticized the agency as too worried about side effects, making it tougher for new drugs to reach the market.
"There's no doubt that the FDA is obviously much more conservative," Merck & Co Inc (MRK.N: Quote, Profile, Research, Stock Buzz) Chief Executive Richard Clark said at the Reuters Health Summit in New York.
"Certainly I'm hoping with the new administration that we have an independent, scientific, medically based agency that is well-funded," Clark added.
At the same time, Schering-Plow Corp SGP.N Chief Executive Fred Hassan warned that a tough environment could force companies to consolidate, as only bigger players would be able to meet drug approval standards.
"If the regulatory pathway remains difficult, very difficult, then those with the largest financial resources will obviously be the ones to finish these projects all the way through," Hassan said by telephone.
Agency officials were stung by the 2004 withdrawal of Merck's arthritis pill Vioxx over heart risks and criticism from lawmakers for their handling of serious side effects of other widely used medicines.
Meanwhile, the FDA staff was stretched thin by a growing workload. The agency has missed some target dates for deciding whether to approve new medicines, leaving them in limbo for weeks or months.
Dr. John Jenkins, director of the FDA's Office of New Drugs, said the agency has not changed its standards. Instead, FDA officials have been applying new understanding about potential side effects.
"Our job is to try to get the balance of benefit and risk, and the speed and access, about right. I think we get it about right. Do we make everyone happy? No," Jenkins said at the Reuters summit.
The FDA lacked a permanent commissioner for more than half of Republican Bush's tenure, a trend executives want to see end after Democrat Obama takes office in January.
"Any organization, especially one with that kind of scientific mission, benefits from stability in leadership," Pfizer Chief Executive Jeff Kindler said.
It is now widely agreed the FDA "needs to be led by a strong, independent leader with very strong, independent, scientific credentials and credibility," Kindler added.
Schering-Plough's Hassan backed a fixed term for the FDA's top post to help protect the leader from political influence. Continued...
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