The Association for Accessible Medicines has submitted a statement for the record to the Senate Finance Committee regarding the Senate Finance Hearing on Tuesday, entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Manufacturing Inspection Process.”
"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," AAM said.
AAM said that 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."
AAM said that what is often overlooked is that the generic pharmaceutical industry has a very large manufacturing presence 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, or 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."
AAM added, "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."
Finally Jeff Francer, AAM interim CEO and general counsel said, “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.”