U.S. Senate bill designed to alert FDA to potential drug shortages

Billings Gazette

by Cindy Uken

The unprecedented level of drug shortages has captured the attention of federal lawmakers, prompting some, including Sen. Jon Tester, D-Mont., to support legislation to stop the dearth.

The Preserving Access to Life-Saving Medicines Act was introduced Feb. 7 and sponsored by U.S. Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Pa. It would increase the authority of the Food and Drug Administration to address the problem.

The legislation would require prescription drug manufacturers to notify the FDA early on of any incident that would likely result in a drug shortage. Such circumstances might include changes to raw material supplies, adjustments to manufacturer production capabilities and certain business decisions such as mergers, withdrawals or changes in output.

The legislation would also direct the FDA to provide up-to-date public notification of any shortage situation and the actions the agency would take to address them. Currently, drug companies are not required to give notice if they know shortages are looming.

To date, at least 10 U.S. Senators have signed on as co-sponsors. All are Democrats.

“As long as there are Montanans who depend on prescription drugs to stay alive, we need safeguards to make sure those drugs are available,” Tester said. “I’m behind this bill because it will help bring predictability to the supply of prescription drugs – and that’s right for Montana.”

Sen. Max Baucus, D-Mont, has not yet signed on as a co-sponsor though he said making sure Montanans have access to all the health care resources they need, including affordable prescription medicines, is one of his top priorities.

“I take concerns about prescription drug shortages in Montana very seriously and I’m reviewing all possible legislative solutions carefully to make sure they work for Montana,” Baucus said.

Though the legislation was initiated in the Senate, it has captured the attention of U.S. Rep. Denny Rehberg, who is challenging Tester in the 2012 U. S. Senate race.

“It’s unthinkable that anyone in this country would suffer or even die as the result of a preventable drug shortage,” Rehberg said. “There’s no easy solution since these shortages are caused by a wide variety of things, but I look forward to working closely with the FDA, Montana pharmacies and private drug providers to find a workable solution.”

The American Society of Health-System Pharmacists calls the legislation a “critical first step toward addressing the serious public health threat posed by drug shortages” and is asking its members to lobby for its passage.