2009 Saw Record 1,742 Drug Recalls
Washington, DC - Michael Bennet, U.S. Senator for Colorado, is making a push to protect consumers and Colorado families by improving the safety and quality of U.S. drugs.
As concerns continue to mount over the safety and quality of pharmaceutical drugs sold and consumed in the United States, Bennet today introduced the Drug Safety and Accountability Act of 2010, which would enhance the ability of the Food and Drug Administration (FDA) and the pharmaceutical industry to ensure U.S. drugs are both safe and effective regardless of where they are made.
The bill would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.
“Making sure pharmaceutical drugs meet the highest standards for safety and quality is important to me, not only as a U.S. Senator, but as the father of three little girls as well,” said Bennet. “For too long, the FDA has lacked the proper authority to adequately safeguard our drug supply and protect Colorado consumers. It’s time Washington took action to ensure the medicines Coloradans rely on are safe, and that those entrusted with the responsibility of developing these drugs are equipped to keep consumers out of harm’s way.”
In 2009, there were a record 1,742 drug recalls – a four-fold increase from the prior year, and the vast majority were related to manufacturing quality and testing. Ensuring quality is made more difficult by the globalization of drug manufacturing. Up to 80 percent of the active ingredients in U.S. drugs are now made overseas, many in countries where regulatory oversight does not meet U.S. standards.
Most Americans are concerned about drug safety, particularly the safety of drugs manufactured overseas. And they support increased regulation, according to a Pew Prescription Project poll released today. Seventy percent of respondents have little or no confidence that drugs manufactured in China are free from contamination and safe for Americans. Fifty-four percent of respondents expressed the same concern about drugs manufactured in India. Ninety-four percent of Americans favor giving FDA recall authority for drugs.
Bennet’s bill would provide the FDA with additional recall power, as well as other much-needed enforcement options, to respond appropriately to violations. The bill would provide better tools to investigate threats to drug quality and safety such as:
- Granting the FDA the authority to assess civil penalties for violations of the Food, Drug and Cosmetic Act and to subpoena documents and witnesses;
- Facilitating exchange of information between the FDA and other regulatory agencies; and
- Protecting industry whistleblowers that wish to bring information to the FDA.
“With record numbers of voluntary drug recalls in 2009, Americans rightly are worried about the safety and quality of drugs manufactured in developing countries,” said Allan Coukell, director of the Pew Prescription Project. “Consumers are asking Congress to take steps to protect them. This bill will help to protect the drug supply chain by strengthening manufacturing quality standards throughout the pharmaceutical industry, which is critical as drug companies increasingly rely on contractors in countries where regulatory standards may be lower than those in the United States.”
To boost manufacturer 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; and
- Ensure companies are able to document which entities are involved in the manufacturing supply chain for their drugs.
The bill would also provide new oversight of over-the-counter (OTC) drugs. FDA has traditionally focused oversight on manufacturers of prescription drugs rather than manufacturers’ OTC products, which are taken by Americans every day. Serious quality issues have been identified at a number of OTC plants in recent years. The bill would prevent FDA from relegating OTC drugs to a lower-risk category for site inspection simply because of their status.
Moreover, current FDA tracking systems for manufacturing sites contain data errors and duplicate entries, and the Government Accountability Office (GAO) has found that multiple tracking systems are not interoperable, preventing meaningful data comparison that could help the agency better target its oversight. 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 ingredients for the U.S.