Bill Would Bolster Manufacturing Quality, Raise Safety Standards and Grant FDA Authority to Protect American Consumers
Bennet Proposals Also Included in FDA Reauthorization Medical Device Plan
Colorado U.S. Senator Michael Bennet, along with Senators Tom Harkin (D-IA), Mike Enzi (R-WY), Richard Burr (R-NC), Chuck Grassley (R-IA) and Sheldon Whitehouse (D-RI), today unveiled a bipartisan plan to protect Colorado consumers and families by improving the safety and quality of prescription and over-the-counter drugs in the United States.
The senators release a discussion draft of a bill that 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 is one component of a larger FDA reauthorization.
“When Coloradans are sick or hurt, they should not have to worry about the safety and effectiveness of the drugs in their medicine cabinet,” said Bennet. “Over the past few years, we have seen record recalls and case after case of tainted or ineffective medicine reaching our hospitals and drug store shelves. This bill would provide the necessary authority for the FDA to ensure our drugs are safe and to hold drugs manufactured abroad to the same standards we hold those manufactured in the United States.”
The plan would strengthen manufacturer quality standards, enhance the FDA’s ability to protect Americans through improved tracking and oversight of foreign manufacturing sites, require manufacturers throughout the supply chain to register with the FDA, and increase the penalty for counterfeiting drugs. It also would shift the burden to manufacturers to prove a drug is safe when entering the U.S., instead of waiting for a complaint or issue to arise about a drug being dangerous.
This discussion draft expands on Bennet’s Drug Safety and Accountability Act that he introduced last Congress in response to the record-high number of drug recalls. In 2009, there were a record 1,742 drug recalls – a fourfold 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 and 40 percent of the finished drug products that enter the United States are now made overseas, many in countries where regulatory oversight does not meet U.S. standards.
In 2008, 21 deaths were traced to the drug Heparin, which is commonly used as blood thinner. The investigation pointed to a tainted supply of the active ingredient, which was manufactured at a plant in China.
The plan 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 databases for manufacturing sites contain data errors and duplicate entries, and the Government Accountability Office (GAO) has found that multiple data 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 United States.
In addition to the drug safety component of the FDA reauthorization, a medical device component also was released today. The medical device discussion draft includes Bennet-backed measures to improve safety and innovation in medical devices, including language from Bennet’s bill to give the Food and Drug Administration the tools it needs to improve oversight of medical devices, as well as Bennet’s bill to reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market.
Last year, Bennet penned an op-ed for Politico titled, “How Safe Is Your Medicine Cabinet?”, which laid out the case for comprehensive FDA reform that protects patients from potentially dangerous and adulterated drugs. He also delivered the keynote address at the Pew Charitable Trusts’ conference in March titled, “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply,” in which he highlighted the need for increased industry and regulatory controls to protect patients and ensure the safety of drugs in the United States.