Target: Drug shortages
User-fee bill addresses prescription disruptions
A Senate-passed measure to renew expiring user-fee programs for drug and device manufacturers also would address the growing concern over drug shortages. The House of Representatives was expected to consider its user-fee measure on Wednesday.
The bill reauthorizing the Food and Drug Administration’s user-fee programs and creating new generic and biosimilar user-fee programs passed the Senate 96-1 on May 24. The programs are intended to improve, expedite and help pay for product reviews.
The bill includes several initiatives aimed at relieving prescription drug shortages. It would require manufacturers to provide expanded notification to HHS of potential shortages or disruptions and give the FDA authority to expedite drug reviews aimed at mitigating the effects of a shortage. It also would allow regulators to conduct expedited inspections of facilities that could help prevent a shortage and establish an Hhs-led task force to mitigate and prevent shortages through public-private coordination and planning.
“This plan would ensure FDA prioritizes drug shortage concerns, enhance FDA’S knowledge of potential drug shortages before they happen and give them the tools to address and mitigate them when they arise,” Sen. Michael Bennet (D-colo.) said in a
Such shortages force providers to choose between prescribing prohibitively expensive drugs or utilizing drugs from “nontraditional” sources that do not reliably provide safe and effective medications, said supporters of the bill. For instance, an August 2011 study by Premier healthcare alliance found that during massive drug shortages, providers faced price gouging attempts by “gray market” vendors offering shortage drugs at an average of 650% their normal cost.
“A record number of drug shortages has had an adverse effect on public health and safety, and is a contributing factor to rising healthcare costs,” Blair Childs, senior vice president of public affairs for Premier, said in a written statement issued after the Senate vote. “Given the severity of the issue, we believe requiring drug companies to provide early notification of anticipated shortages to the FDA is essential.”
Another provision requires the FDA to fully implement a unique device identification system for medical devices. The UDI system was originally required in the 2007 iteration of the user fee reauthorization but implementing regulations were never issued. Some provider advocates said the medical device identifier program is necessary to track down flawed products and mitigate the harm to patients.
The bill also addressed the increasing incidence of counterfeit drugs appearing in the U.S. pharmaceutical supply by adding penalties for intentionally counterfeiting drug products. Drug counterfeiting penalties currently are the same as those imposed for the creation and sale of any other false product.
“Illegal counterfeit drugs are a multibilliondollar global industry that’s growing at an alarming pace, especially online, so there’s no time to waste in creating an effective deterrent and making certain that justice is served with meaningful penalties,” Sen. Chuck Grassley (R-iowa) said in a written statement.