Drugs

Legislation Introduced on Drug Supplies, Shortages

Senators Gary Peters (D-MI) and Joni Ernst (R-IA) have introduced bipartisan legislation to ensure the government is better prepared to address the national security threat posed by overreliance on foreign sources for critical medications. The legislation responds to two reports released by Peters in 2019 and2023 that identified national security concerns and a lack of transparency with the U.S. pharmaceutical supply chains, according to a Peters news release.

The Pharmaceutical Supply Chain Risk Assessment Act would require the Departments of Defense, Health and Human Services, and Homeland Security to “conduct a comprehensive assessment of pharmaceutical supply chain vulnerabilities and related national security risks, as well as develop plans to reduce our nation’s reliance on foreign nations for critical drugs,” the release says. The assessment will also help lawmakers craft additional legislation to mitigate the supply chain threats, it says.

Meanwhile on the House side, Energy and Commerce Democrats are echoing calls from a 6/19 Wall Street Journal article citing experts who are urging Congress to give “FDA authority to routinely conduct surprise overseas inspections and compel generic manufacturers to be more transparent about their supply chains.”

The Democrats say they have repeatedly called on the Republican majority to include provisions to address the national drug shortage in the reauthorization of the Pandemic and All-Hazards Preparedness Act this year. “Unfortunately, Republicans continue to refuse to consider provisions to address the national drug shortage, including Health Subcommittee Ranking Member Anna G. Eshoo's (D-CA) Drug Origin Transparency Act and Rep. Andy Kim’s (D-NJ) Protecting Americans from Unsafe Drugs Act,” they say in a 6/20 release.

Eshoo’s bill, they say, would help doctors and patients know where drugs and their ingredients are sourced from and require drug manufacturers to report to FDA quarterly the suppliers they rely on. “It would also require manufacturers to include on the drug’s public-facing label the name and place of business of the manufacturers of the drug and its active pharmaceutical ingredients,” they continue. “Kim’s bill would allow FDA to mandate drug recalls when a manufacturer refuses to comply with a request to do so voluntarily.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome