Senate Introduces New Bill on Drug-Manufacturing Quality Standards

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.
 
According to a press release from Bennet’s office, the bill would strengthen manufacturing quality standards, enhance the US Food and Drug Administration’s ability to track foreign manufacturing sites, and increase the authority of FDA to make drug product recalls. In his release, Bennet noted that there were 1742 drug recalls in 2009, a record amount, which represents a 400% increase from 2008. The release also indicated that most of the recalls were related to manufacturing quality and testing. Bennet's bill would provide tools to investigate threats to drug quality and safety such as by granting FDA the authority to assess civil penalties for violations of the Food, Drug and Cosmetic Act and to subpoena documents and witnesses. The bill also specifies measures for facilitating the exchange of information between FDA and other regulatory agencies and for protecting industry whistleblowers who wish to bring information to FDA.
 
To boost manufacturing standards, the bill would require companies to institute quality-management plans to ensure the quality and safety of their drugs and drug components. The plans would include strong supplier oversight, as well as increased documentation in the manufacturing supply chain for drugs. The bill would also provide new oversight of over-the-counter (OTC) drugs by preventing them from being assigned to a lower-risk category for site inspection because of their status. To improve tracking and risk-assessment tools, the bill would require FDA to establish accurate, interoperable information systems to track all plants making drugs and active pharmaceutical ingredients (APIs) for the US.
 
The Society for Chemical Manufacturers and Affiliates (SOCMA), the US trade association that represents custom and batch manufacturers, including contract manufacturers of APIs and pharmaceutical intermediates, and the Bulk Pharmaceuticals Task Force (BPTF), an affiliate of SOCMA, support the measure. “SOCMA and BPTF thank Senator Bennet for introducing this common-sense legislation, which will strengthen FDA and increase public health and safety by providing additional quality controls on drugs and their ingredients,” said BPTF Chairman Brant Zell of Cherokee Pharmaceuticals (Riverside, PA), in a SOCMA release. “…This bill is a good starting point in giving the FDA more authority, tools, and resources to help ensure a safer US drug supply.”
 
Responding to the bill, Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice-President Ken Johnson said in a PhRMA statement, “The lifeline of America’s biopharmaceutical research companies is the safety and integrity of the products they develop. Brand-name pharmaceutical companies make tremendous investments in quality-control systems and take extensive measures to help protect patient safety and to help prevent adulterated ingredients from entering into America’s prescription drug supply." He also stated, "In addition, drug manufacturing for the US market-regardless of where it occurs-is regulated under good manufacturing practices (GMP) by the Food and Drug Administration. These GMP requirements help to assure the safety, quality and purity of drug ingredients that are used in the US prescription drug supply.”
 
The newly introduced bill follows the passage of the Food Safety Enhancement Act of 2009 (HR 2749) by the US House of Representatives in 2009. HR 2749 also sought to address issues relating to drug-manufacturing quality and related issues. That bill was subsequently referred to the Senate Health, Education, Labor, and Pensions Committee for consideration.