Washington, DC – Colorado U.S. Senator Michael Bennet today released the following statement on the U.S. Food and Drug Administration’s new strategy to help ensure the safety and quality of imported FDA-regulated products.
“Most Americans hardly think twice about whether the drugs in our local pharmacy and supermarket are safe. During their busy daily lives, they rarely question the potential that their medicine will actually harm them and they trust their government has taken the necessary safeguards. But that isn’t always the case. With more and more pharmaceuticals manufactured abroad, the FDA lacks the proper authority to adequately safeguard our drug supply and protect Colorado consumers.
“The new strategy announced by the FDA today is an important step forward, but there is more work to do to ensure the medicines and products Coloradans rely on are safe and will not put them and their families in harm’s way. We need a greater capacity for inspections, a better way to track drugs and their ingredients through the supply chain and harsher penalties.
“A strong drug supply chain that protects American consumers is a matter of common sense, national security, and consumer safety.”
The FDA “Pathway to Global Product Safety and Quality” report calls for the following changes to protect American consumers:
- The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
- The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
- The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
- The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
This initiative builds upon work discussed by the FDA at The Pew Charitable Trusts’ conference in March titled, “After Heparin: A Roundtable on Ensuring the Safety of the U.S. Drug Supply,” where Senator Michael Bennet delivered the keynote address and highlighted the need for increased industry and regulatory controls to protect patients and ensure the safety of drugs in the United States.
Last year, Bennet 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. For more information on this bill, please click here. He is currently working on an expanded bipartisan version of that bill to be introduced later this year.
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.