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Senate committee report highlights a lack of visibility in API suppliers.
Drug shortages in the US have been an ever-present concern in hospitals and pharmacies for years, with the worry ranging from irritating to desperate as the count of short-supply drugs waxes and wanes. Now, the Senate Homeland Security and Governmental Affairs Committee is raising its importance to a matter of national security. The count of short-supply drugs reached a recent high 295 at the end of 2022, up 30% over 2021, according to a committee report issued during a March 22 hearing. Causes and possible remedies (such as manufacturers alerting FDA to upcoming supply disruptions) were analyzed in 2019, but the pandemic more clearly revealed manufacturing and supply-chain problems since then. One clear indicator getting more attention is that even when there are multiple suppliers of some finished products, the active pharmaceutical ingredients (APIs) might be coming from only one or a few sources. And FDA is not in a position to realize or respond to that.
“There are a number of factors that contribute to drug shortages, including economic drivers that lead to a lack of manufacturers willing to enter or remain in the market or invest in quality manufacturing systems, insufficient visibility into the entire supply chain for critical medications, and an overreliance on foreign and geographically concentrated sources for the materials needed to make these drugs,” says Sen. Gary Peters (D-Mi), head of the committee, in an opening statement. Suggested improvements in the report include: more investment in private-public partnerships to “onshore” critical generic manufacturing capacity; conduct interagency medical supply chain risk assessments, including cybersecurity; and that FDA should “prioritize its development of a key starting material database . . . to assess end-to-end supply chain visibility.”
Sen. Rand Paul (R-KY), as minority chair, issued his own statement: “The drug industry is one of the most regulated markets in the economy. Output controls, such as FDA’s approval procedure for nearly every step of the manufacturing process, increase the cost of production and restrain the adaptability of manufacturers to meet shifting demands. . . . Why does the United States embrace central planning in healthcare?” (Sen. Paul’s antipathy to FDA is generational; his father, former Rep. Ron Paul, wanted to shut down FDA during his 2008 presidential campaign.)