A White House health policy adviser on the American President's Council of Economic Advisers has been chosen to fill the role, empty since January 2001, of commissioner for the US Food and Drug Administration, said a Bloomberg report based on sources close to the nomination.
Mark McClellan, a doctor by training, is to fill the post that has been vacant since former commissioner Jane Henney resigned in January 2001. McClellan has not yet commented on the news.
A new leader at the food, drug and medical device safety agency would be welcomed by investors as it may mean faster product approvals. The time from application to approval for new medicines in the US increased to 20 months from 13 months over the past four years, according to a congressional report, said Bloomberg.
"The agency was in slow-down mode and ultra-safety mode when they were looking for a leader,'' said James King, co-manager of the First American Health Science fund, which owns pharmaceutical, biotechnology and medical device shares.
The report continues that the FDA regulates products that account for about 20 cents of every dollar spent in the US, and commissioners can play a significant role in setting national policy. Former FDA Commissioner David Kessler headed up the agency's battle to regulate tobacco as a drug and his successor, Henney, oversaw the FDA's approval of the abortion pill RU-486.
McClellan apparently has no ties to the drug industry, which may make winning confirmation in the Democratic-controlled Senate easier.
"He meets the primary requirements of not being from industry and being a doctor,'' said Ira Loss, an analyst who follows the FDA for the firm Washington Analysis. "He has been confirmed by the Senate for the position that he holds and he held a position during the Clinton administration in the Treasury. If that's considered bipartisan support, he has it.''
An administration official and an aide to a Senate Democrat said Bush will announce the nomination before Congress adjourns for the year next month.
"Dr McClellan has impressive credentials, both as a physician and as an economist, and I look forward to learning more about his views on issues that are critical to the FDA,'' said Senator Edward Kennedy, the Massachusetts Democrat who heads the committee that must approve the nomination, in a statement.
"The governing principle seems to have been to find the guy with no closet because there won't be any skeletons,'' said Peter Lurie, deputy director of Public Citizen's Health Research Group, a consumer activist group. "He appears to have no great experience with matters under the jurisdiction of the FDA.''
The Bloomberg report also noted that the Congress's General Accounting Office released a report today which found that the FDA's effort to speed drug approvals has created more staff turnover, delayed the most innovative medicines and cut into resources for oversight of food and devices. At the same time, the agency is facing criticism for a spate of withdrawn medicines linked to deaths and side-effects.