With drug shortages becoming increasingly common and drawn-out affairs in the U.S., House Republicans are pressing the FDA for answers. At the heart of the investigation is whether the FDA has done enough to prevent and respond to the current spate of shortfalls, which have affected cancer meds and nonprescription painkillers alike.
In a letter published Wednesday, Republican leaders from the House Committee on Energy and Commerce pressed FDA Commissioner Robert Califf, M.D., to respond 10 questions on the FDA’s tracking of scarce medicines, its inspection priorities and what the agency has done to parse and prevent shortages of more than half-a-dozen drugs.
The FDA keeps tabs on current drug shortages and says it works with manufacturers and other links of the supply chain to thwart medicine deficits. The regulator has also requested additional legal authority from Congress to get a clearer sense of medical supply chain information, according to the lawmakers' letter.
What isn’t clear, however, is whether “FDA is effectively using its existing authorities,” the committee said.
To get to the bottom of the issue—and better understand the FDA’s response—the committee is seeking answers to nearly a dozen questions by April 10.
The committee wants to know more about the drug shortages reported in 2020, 2021 and 2022, including where each drug was manufactured, whether the drugs are listed on the FDA’s online drug shortage database “as required” and whether the medicines in question rank among the regulator’s list of essential drugs.
The lawmakers are also asking how information received by the FDA informs its foreign inspection priorities, and it wants stats on companies who’ve failed to report on their annual drug production stats.
As it stands, the FDA’s online drug shortage database lists more than 120 drugs in short supply. The American Society of Health System Pharmacists has separately logged more than 233 shortages. The problem has been getting worse over the past decade, and shortages are now lasting much longer than before, the committee contends, citing a report from the National Academies of Sciences, Engineering and Medicine.
The FDA, for its part, has been trying to get a handle on the situation. Last May, the agency rolled out new draft guidance to help manufacturers forge risk management plans aimed at combatting drug shortages. Under the guidance, manufacturers of certain drugs would be required to implement those plans, while for others, the move is simply recommended.
The plan didn’t go over well with everyone, however, drawing heat from U.S. pharma lobbying bigshots PhRMA and BIO as well as outfits like Civica and the Biosimilars Forum. Much of the criticism centered on the allegedly confusing nature of the FDA’s recommendations.
The drug shortage issue isn’t unique to the U.S.. Back in January, European officials flagged increased demand for antibiotics like amoxicillin as an “ongoing public health concern.” Further, manufacturing delays and production capacity issues have fueled supply problems across a “majority” of EU member states, officials from the bloc said earlier this year.