MARYLAND MATTERS: Maryland U.S. Sen. Ben Cardin (D) is hoping to address continuing prescription drug shortages in a new bill by attempting to extend shelf-life dates listed for certain essential drugs and requiring manufacturers to report when drugs are in higher demand, among other measures.
The recently filed bill would provide the U.S. Food and Drug Administration the ability to fine drug manufacturers if they do not report shortages in a timely manner, according to a press release.
“We have incredible medicines available that can save lives – but only if they can reach patients in a timely way,” Cardin said in a written statement. “Last Congress, we made historic progress addressing health care costs through the passage of the Inflation Reduction Act. However, for patients to benefit from these lower prices, manufacturers and the federal government must work in tandem to ensure life-saving medications remain consistently available for those who need them.”
Cardin is sponsoring the bill alongside U.S. Sen. Tina Smith of Minnesota and U.S. Sen. Richard Blumenthal of Connecticut, both Democrats.
Drug shortages have been an issue for several years and can lead to major upheavals in the lives of patients who depend on them.
The U.S. Senate Committee on Homeland Security & Governmental Affairs reported that prescription drug shortages increased by about 30% from 2021 to 2022, according to the press release.
But data from the FDA show that some drug shortages can be attributed to quality concerns and insufficient upgrades to manufacturing lines.
“An FDA Drug Shortages Task Force report found that 62 percent of drug shortages from 2013-2017 were caused by quality concerns. Some of the facilities FDA has tied to drug shortages have been operating continually since the 1960s with minimal upgrades to manufacturing lines and facilities,” the press release notes.
The new legislation would create a grant opportunity for manufacturers to upgrade their manufacturing process in order to produce sterile injectable drugs — medications that are administered through a syringe or needle — faster to avoid future shortages.
The bill also would require manufacturers to notify the FDA if they are experiencing higher demand for a drug that is likely to lead to a shortage. The FDA could then issue a fine of up to $50,000, per violation, if the manufacturer has knowledge of increased demand for the drug and does not report it within 30 days.
Manufacturers also would be required to update a product’s shelf-life to “the longest supported expiration date,” or face a financial penalty from the FDA.
The press release notes that the legislation has been endorsed by the American College of Emergency Physicians, the Association of Food and Drug Officials, and the American Pharmacists Association.
“Drug shortages jeopardize the health and well-being of patients in need of lifesaving emergency care,” said Christopher S. Kang, president of the American College of Emergency Physicians, in a written statement. “Shortages of essential medications used every day in lifesaving procedures are increasingly putting patients at avoidable risk and causing dangerous treatment delays.”
