AAM Statement on Senate Finance Hearing on FDA’s Foreign Manufacturing Inspection Process

WASHINGTON, DC (June 2, 2020) — The COVID-19 crisis exposed many shortcomings in our health care system’s ability to respond to a pandemic. At the same time, many parts of that same system — including the supply chain for the vast majority of generic medicines — demonstrated extraordinary resiliency in the face of unprecedented stresses.

There are many factors that contributed to the resiliency of the American generic pharmaceutical supply chain throughout this crisis. Our industry spends significant resources on contingency planning for unforeseeable events to ensure that necessary medicines can reach patients in the most adverse circumstances. The nature of our industry means that there are often multiple manufacturers of a given drug, and multiple sources for raw materials needed to produce that drug.

What is often overlooked is that the generic pharmaceutical industry has a very large manufacturing presence here in the United States already. The generic pharmaceutical industry manufactures approximately 70 billion doses in the United States annually, supporting 36,000 jobs at nearly 150 facilities across the country, comprising 24% of the facilities inspected by the FDA.

AAM and its members understand that there are always improvements that can be made to any system. AAM and its members have a long track record of advocating for greater and more effective FDA oversight of the supply chain, both foreign and domestic. AAM was a strong supporter of the original generic drug user fee program (GDUFA) in 2012 and, as part of GDUFA II in 2017, our industry committed an additional $4 billion, in large part to increase the frequency of FDA inspections of foreign facilities.

Building on our companies’ longstanding commitment to the safety and security of the American pharmaceutical supply chain, AAM recently released a first-of-its-kind “Blueprint to Enhance the Security of the U.S. Pharmaceutical Supply Chain” that builds upon the already significant generic manufacturing base in the United States. The blueprint addresses many of the systemic issues that will be discussed at the Senate Finance Committee hearing with concrete solutions, and we are in active discussions with Congressional and Administration leaders about the proposals it contains.

“AAM and its member companies are committed to working constructively with Congress and the Administration to chart a path forward so that American patients may continue to depend on a diverse and resilient pharmaceutical supply chain to produce and deliver the safe, effective and affordable medicines that they count on,” said Interim CEO and General Counsel Jeff Francer.

View Testimony

Rachel Schwartz


About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. 

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

Association for Accessible Medicines


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