Sen. Bennet Calls for Increased Accountability for Pharmaceutical Companies
By Mike Rozembajgier
Proposals aimed at tightening regulations governing the medical device and pharmaceutical industries seem to be picking up speed. Aside from the U.S. Food and Drug Administration’s (FDA) proposed new requirements for medical devices, Sen. Michael Bennet (D-CO) recently introduced legislation that would expand the FDA’s powers to hold pharmaceutical companies accountable for the products they sell, including the power to recall them.
Last month, the Pew Prescription Project released a poll which found that 89 percent of Americans support Congressional action to tighten drug safety regulation. The poll also reported that 58 percent of those surveyed said they “strongly supported” such action. Last year there were 1,742 pharmaceutical recalls in the United States, a 400 percent increase since 2008.
Currently, the FDA has recall power over medical devices, but not drugs. Not only would Bennet’s proposal expand the FDA’s authority to recall drugs if safety issues arise, it would also grant the FDA subpoena power during its investigations, including those related to recalls.
Under the provisions of Sen. Bennet’s Drug Safety and Accountability Act, pharmaceutical companies would face tougher requirements for documenting and tracking each and every supplier and third-party provider involved throughout the production of their products. With an estimated 80 percent of all active ingredients used in U.S. pharmaceuticals coming from manufacturing plants overseas, this bill looks to strengthen global standards, particularly where local manufacturing standards are lower than those required by the U.S. Along these lines, the bill would also require the FDA to update its data systems to track all global suppliers that feed into the U.S. drug supply.
Companies with a global supply chain must understand that, under these proposed regulations, they could be held accountable for the production of every ingredient and process used to manufacture a product. Pharmaceutical companies should begin ramping up their own internal standards for the manufacturers and suppliers they work with in order to prepare for the proposed changes in FDA’s reporting protocol and regulations.
Whether or not Sen. Bennet’s bill passes, you can count on lawmakers to bring other proposals to the table in an attempt to increase the FDA’s power to regulate your industry. While this proposal may only be a warning of tougher regulations to come, it definitely signals that this issue is important not only to consumers, but to lawmakers and regulators.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.