Funding Bill May Address Drug Shortages: Aides
WASHINGTON (Reuters) Feb 01 – Legislation aimed at relieving shortages of crucial drugs used to treat cancer and other illnesses may get momentum next week when lawmakers decide whether to attach it to a must-pass funding bill for the U.S. Food and Drug Administration, congressional aides said on Tuesday.
A House of Representatives hearing next week about FDA funding will address the shortage of life-saving medicines, said the aides, who spoke on condition of anonymity.
The number of drugs in short supply rose from 56 in 2006 to 220 in 2011. Some doctors have had to postpone care or use second-best drugs or more costly alternatives to compensate for shortages.
President Barack Obama made shortages a national priority with an executive order in October, and urged Congress to quickly pass legislation to address the issue.
Two bills that would force drug companies to tell the FDA about looming shortages have been stuck in a deadlocked Congress this year, despite bipartisan support. A third bill was introduced on Tuesday.
Next week’s House hearing is part of the process to renew FDA user fees, or the funds companies pay to the agency in exchange for faster review of drugs and devices.
Congress must renew the Prescription Drug User Fee Act (PDUFA) every five years. The current legislation is due to expire in September.
"We’re hoping that the user fee bill can be a vehicle for the (drug shortages) language," said one congressional staffer familiar with the matter.
Since fees from makers of drugs and medical devices provide more than a third of the FDA’s funding, the bill often serves as a vehicle for broader FDA-related changes.
The Senate is also working on including the issue of drug shortages in the FDA user fee legislation, another aide said.
On Tuesday, Representatives John Carney, a Democrat from Delaware, and Larry Bucshon, a Republican from Indiana, proposed the third drug shortages bill.
Among other measures, this legislation would force the FDA to speed up its review of applications from companies that want to change or ramp up production to address shortages.
It would also require the Drug Enforcement Administration (DEA) to raise its quota for certain controlled substances if they are needed for a drug in short supply.
Manufacturers have said the DEA’s quota system has prevented them from increasing production of drugs such as Adderall to treat attention deficit hyperactivity disorder.
"Certainly the user fee reauthorization is the most likely course of action" to get Carney and Bucshon’s bill passed, a third aide said.