Mikulski bill would speed approval of new drugs by FDA
By By John Fritze and The Baltimore Sun
Feb 02, 2012 at 6:16 AM
WASHINGTON — — Drugs for chronic conditions such as Alzheimer's disease and diabetes would move through the Food and Drug Administration approval process more rapidly under a bipartisan bill Sen. Barbara A. Mikulski will unveil Thursday.
The legislation, which will have Republican co-sponsors in the House and Senate, would direct $50 million to increase the number of experimental drugs that enter the FDA approval pipeline. To receive a grant under the program, private companies would have to put up $2 for every $1 spent by taxpayers.
"By acting now, we can save billions in future health care spending and long-term care costs," the Maryland Democrat said in a statement. "This bill saves lives and saves money."
The proposal is intended to help drugs clear a critical and expensive hurdle between initial discovery and FDA testing — a phase known in the industry as the "Valley of Death" because development of so many drugs stalls for lack of funding. It can take up to 15 years for a new drug to receive final approval.
The review process would also be sped up for certain drugs funded under the proposed program, though the legislation leaves it to the U.S. Department of Health and Human Services to determine an appropriate timeline.
Mikulski, whose father died of Alzheimer's, is a long-established champion of attempts to fight the disease. The senator, who sits on the Senate Health, Education, Labor and Pension Committee, has previously sponsored legislation to increase federal funding for Alzheimer's research.
The new legislation has support from Sen. Susan Collins, a Maine Republican, as well as New Jersey Republican Rep. Chris Smith. But given the partisan gridlock in Washington — particularly on any proposal that calls for new spending — the bill will face significant scrutiny.
George Vradenburg, co-founder of a Washington-based advocacy group called US Against Alzheimer's, framed the issue in the larger context of an aging society and spiraling health care costs, including many paid for by taxpayers through Medicare and Medicaid.
"There are good ideas coming out of the laboratories," Vradenburg said of drug discoveries for Alzheimer's and other diseases. "They simply cannot find a company to take them up."