As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain.
According to a press release by 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, and a 400% increase from 2008. The release also indicated that most of the recalls were related to manufacturing quality and testing.
The bill would provide better 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 exchange of information between FDA and other regulatory agencies and protecting industry whistleblowers that 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, including strong supplier oversight, as well as increase documentation in the manufacturing supply chain for drugs. The bill would also provide new oversight of over-the-counter (OTC) drugs by not having OTC drugs 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 legislation is supported by industry groups. The Society for Chemical Manufacturers and Affiliates (SOCMA), the US trade association representing 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 Pharmaceutical, 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.”
In response to the bill, Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice-President Ken Johnson said: “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 said in a PhRMA statement. “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.”
Following the heparin incident several years ago, there was much Congressional attention to the issue of drug-manufacturing oversight, including of overseas facilities, and in finding ways to improve regulatory enforcement of the increasing more global and longer pharmaceutical supply chain. A key piece of legislation was the passage of the Food Safety Enhancement Act of 2009 (HR 2749) by the US House of Representatives in 2009, and which was subsequently referred to the Senate Health, Education, Labor, and Pensions Committee for consideration.
Changing legislative priorities punctuated by high-profile policy issues such as healthcare and financial-industry reform, however, put the issue of drug-safety on the legislative backburner. Although Congress is not likely to do anything with the recently introduced bill before the summer recess, it is encouraging that at least the subject is back on the legislative agenda and that it is something to monitor for the upcoming fall legislative session.