New legislation introduced into the US Senate this week would require drugmakers to give early notification to the Food and Drug Administration of any incident that would likely result in a drug shortage.
The Preserving Access to Life-Saving Medications Act, introduced by Democrat Senators Amy Klobuchar and Bob Casey, would also direct the FDA to provide up-to-date public notification of any shortage situation and actions which the agency would take to address them.
The American Society of Health System Pharmacists (ASHP) currently lists 150 “medically necessary” drugs that are in short supply, double the number from five years ago, with particular shortages of cancer drugs, and physicians, pharmacists and patients are currently among the last to know when an essential drug will no longer be available, said Sen Klobuchar.
“It is important that we have better coordination between the pharmaceutical industry, the FDA and health care providers, so patients don’t lose access to the medications they depend on,” she said.
Sen Casey added that several major hospitals in his state, Pennsylvania, had experienced drug shortages that were jeopardising patient care.
Pharmacists and health care providers have been reporting “unprecedented” shortages of prescription drugs, especially for chemotherapy, and there is also a serious shortage of pre-filled epinephrine syringes used in emergencies to treat heart attacks and allergic reactions, the Senators note. Experts cite a number of factors behind the problem, including shortages of some raw materials, manufacturing problems, unexpected demand and also business decisions within the pharmaceutical industry such as mergers, withdrawals and “cutting back on the production of low-cost generic drugs in favour or more profitable brand-name drugs,” they add.
As well as giving the FDA authority to require early notification from drugmakers when they decide to limit or discontinue production of prescription drugs, the Klobuchar/Casey bill would also empower the agency, when there is an impending shortage of a drug, to establish an expedited process to approve substitute treatments or the importation of safe, clinically-equivalent drugs from outside the US.
“We want to respect the private market but we also need to protect the public’s health,” Sen Klobuchar told a public meeting recently, adding that her bill proposes a “common-sense solution.”