A broad range of stakeholders has endorsed the Drug Quality and Security Act, legislation introduced by Senate and House health policy leaders to address high-risk drug compounding practices and secure the pharmaceutical supply chain. The bill would improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.
Leaders for the Congressional health committees—Senate HELP committee chairman Tom Harkin (D-IA), HELP committee ranking member Lamar Alexander (R-TN), house energy and commerce chairman Fred Upton (R-MI) and energy and commerce ranking member Henry Waxman (D-CA)—recently agreed to endorse the bill. Senate HELP committee members Al Franken (D-MN), Pat Roberts (R-KS), Michael Bennet (D-CO) and Richard Burr (R-NC) have worked on the bill throughout the process and are original co-sponsors of the legislation.
To date, groups including the American Society of Health-System Pharmacists, the Pew Charitable Trusts, the U.S. Chamber of Commerce, the National Community Pharmacists Association, the Federation of American Hospitals, Premier Healthcare Alliance, the American Medical Student Association, the American Public Health Association, the Annie Appleseed Foundation, the Association of State and Territorial Health Officials, the Center for Science and Democracy, the Union of Concerned Scientists, the Center for Medical Consumers, Community Catalyst, the Connecticut Center for Patient Safety, the National Association of County and City Health Officials, the Ovarian Cancer National Alliance, Trust for America’s Health, Woodymatters, the Healthcare Distribution Management Association, the Pharmaceutical Distribution Security Alliance, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, PharMEDium, the Biotechnology Industry Organization, the National Association of Chain Drug Stores, Pfizer, UPS and Richie’s Specialty Pharmacy have endorsed the Drug Quality and Security Act.
“We believe this bill helps clarify federal oversight of compounding outsourcing facilities, and seeks to create better communication channels between the FDA and state boards of pharmacy. In the interest of patient safety, we urge congress to pass this legislation,” said the American Society of Health-System Pharmacists.
The U.S. Chamber of Commerce said, “The Chamber believes efforts to bolster oversight of compounding pharmacies and institute a federal prescription drug track and trace system are vital to protecting Americans against counterfeit drugs. This bill would help alleviate confusion and reduce costs for businesses in the pharmaceutical sector, as well as improve the safety of patients generally.”
“The Drug Quality and Security Act offers the federal government clear and essential authority to oversee large pharmaceutical compounding companies. At the same time, it will enable hospitals to produce safe, reliable and effective compounded pharmaceutical products for individual patients,” said the Federation of American Hospitals.
PharMEDium said, “We believe this legislation represents an important step forward in clarifying the regulatory oversight of the entire spectrum of compounding operations and safeguarding against future outbreaks due to gaps in regulatory oversight.”