Joint Letter of Support for Swift Action on the MEDS Act
Dear Chairman Alexander and Ranking Member Murray,
As the United States takes steps in response to the outbreak of COVID-19, concerns with the integrity of the drug supply chain and the potential impact on downstream drug shortages have surfaced. While no drug shortages have been reported thus far in direct correlation with COVID-19, past situations such as H1N1, Ebola, and Hurricane Maria have highlighted vulnerabilities in the drug supply chain that require congressional action to ensure a stable supply of critical medications is available for patient care. Furthermore, the World Health Organization (WHO) and the Food and Drug Administration (FDA) have stated the COVID-19 outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the United States.
Therefore, the undersigned organizations are writing in support of S.2723 – The Mitigating Emergency Drug Shortages (MEDS) Act which is a holistic and sustainable approach to eliminating drugs shortages and addressing vulnerabilities in the drug supply chain. We urge the Senate Committee on Health, Education, Labor, and Pensions (HELP) to advance this critical piece of legislation expeditiously.
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Group Comment Letter to FDA on Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products
Dear Commissioner Hahn,
The undersigned groups share the Food and Drug Administration’s (FDA) deep commitment to the development of a robust biosimilars market and appreciate the Agency’s work to develop an efficient approval pathway for biosimilars to bring savings and access to America’s patients. As such, we support the approach outlined in the “Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products” draft guidance. Specifically, we agree with the Agency’s assessment that if a manufacturer demonstrates its proposed biosimilar insulin is “highly similar” to its reference product, the Agency may waive the need for the manufacturer to conduct additional immunogenicity studies in order for the Agency to deem the product as interchangeable with its reference product.
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