Bill Text: WV SR72 | 2020 | Regular Session | Introduced
Bill Title: Urging Congress safeguard pharmaceutical supply chains
Spectrum: Partisan Bill (Democrat 4-0)
Status: (Passed) 2020-03-07 - Completed legislative action [SR72 Detail]
Download: West_Virginia-2020-SR72-Introduced.html
SENATE RESOLUTION 72
(By Senator Stollings)
[Introduced March 6, 2020]
Urging Congress to take steps to safeguard pharmaceutical supply chains in a global economy and revitalize pharmaceutical manufacturing in the United States.
Whereas, The United States, through its investment in biomedical research, has become a world leader in drug discovery and development, but is no longer in the forefront of drug manufacturing; and
Whereas, Historically, the production of medicines for the United States population has been domestically based. However, in recent decades, drug manufacturing has gradually moved out of the United States; and
Whereas, This is particularly true for manufacturers of active pharmaceutical ingredients (APIs), the actual drugs that are formulated into tablets, capsules, injections, etc.; and
Whereas, The security of the nation’s drug supply rests on three main factors: Freedom from dependence on foreign sources of APIs, the resilience of our domestic manufacturing base, and the reliability of the facilities that make products for the U.S. market; and
Whereas, The increasing number of API manufacturing sites in China and other countries suggests that the United States’ reliance on Chinese and other foreign sources of API is growing; and
Whereas, As of August 2019, only 28 percent of the manufacturing facilities making APIs to supply the U.S. market were located in the United States. By contrast, 72 percent of the API manufacturers supplying the U.S. market were overseas, and 13 percent are in China; and
Whereas, The United States Food and Drug Administration’s (FDA) data show that the number of registered facilities making APIs in China more than doubled between 2010 and 2019; and
Whereas, A 2009 report in the New York Times explains that most of the ingredients used for manufacturing critical drugs like antibiotics, allergy medicines, diabetes medications, and high blood pressure medications, are now almost exclusively produced in either China or India; and
Whereas, In July 2018, the FDA announced a voluntary recall of a generic, commonly prescribed blood pressure medication, Valsartan, that may have been contaminated by the carcinogenic toxin N-nitrosodimethylamine. All of the Valsartan flagged for recall by the FDA was manufactured in China; and
Whereas, Eighty percent of active ingredients in America’s pharmaceutical and over-the-counter drugs come from China and India, according to Rosemary Gibson and Janardan Prasad Singh, authors of the book China RX: Exposing the Risks of America’s Dependence on China for Medicine; and
Whereas, Despite the growing number of people that are seriously injured or killed because of tainted drugs produced overseas, little has been done to address this problem; and
Whereas, For instance, in 2008, it was reported that at least 81 people in the United States died from a tainted heparin drug produced in India; and
Whereas, While there are many reasons for this shift, underlying factors that are often cited include the fact that most traditional drug-production processes require a large factory site, often have environmental liabilities, and can utilize a low-cost labor force; and
Whereas, Using traditional pharmaceutical manufacturing technology, a U.S.-based company could never offset the labor and other cost advantages that China enjoys simply by achieving higher productivity; and
Whereas, Indeed, Mylan Pharmaceuticals has recently been purchased by pharmaceutical giant Pfizer; and
Whereas, Pfizer has recently opened new pharmaceutical plants in China and India; and
Whereas, Given the shift to the overseas production of pharmaceuticals it is conceivable that the 3,000 Mylan jobs located in Morgantown, West Virginia, could be lost to manufacturing facilities overseas; and
Whereas, However, the FDA believes that advanced manufacturing technologies could enable U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries, and potentially ensure a stable supply of drugs critical to the health of U.S. patients; and
Whereas, Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market; and
Whereas, The pharmaceutical sector relies heavily on foreign sourcing for critical components, materials, and finished products, as identified by the U.S. Department of Commerce’s Office of Technology Evaluation; and
Whereas, Advanced manufacturing is the use of innovative technology to improve products and processes. Although widely used in some other industries, such as automotive, aerospace, and semiconductors, advanced manufacturing is now just beginning to be used by pharmaceutical companies; and
Whereas, Advanced manufacturing offers many advantages over traditional pharmaceutical manufacturing, and, if the United States invests in this technology, it can be used to reduce the nation’s dependence on foreign sources of APIs, increase the resilience of our domestic manufacturing base, and reduce quality issues that trigger drug shortages or recalls; and
Whereas, By supporting the growth of advanced manufacturing in the United States, we can reduce our dependence on China and other overseas manufacturers for APIs as well as improve the resilience and responsiveness of our manufacturing base and reduce drug shortages; and
Whereas, The adoption of advanced manufacturing technologies may pose a challenge to the current regulatory framework because most regulations were developed based on traditional batch manufacturing methods under a unified pharmaceutical quality system; and
Whereas, These new ways of making drugs could, with the proper strategies, revitalize pharmaceutical manufacturing in the United States; therefore, be it
Resolved by the Senate:
That the Senate hereby urges Congress to take steps to safeguard pharmaceutical supply chains in a global economy and revitalize pharmaceutical manufacturing in the United States; and, be it
Further Resolved, That the Clerk is hereby directed to forward a copy of this resolution to the President and Secretary of the United States Senate, to the Speaker and Clerk of the United States House of Representatives, and to the members of West Virginia’s congressional delegation.
