WASHINGTON, DC – U.S. Senator Gary Peters, Ranking Member of the Homeland Security and Governmental Affairs Committee, today announced he introduced legislation that would grant the Food and Drug Administration (FDA) the authority to recall all unsafe drug products and help protect consumers. Currently, the FDA can only recommend that a company voluntarily recall a drug product, but it cannot require companies to recall these unsafe products. FDA, however, regularly publishes safety alerts relating to over-the-counter medications, prescription drugs, and other regulated drug products like hand sanitizer Recently, the FDA recommended the recall of over 100 hand sanitizer products containing methanol, which can be toxic to humans, but some companies failed to comply.
“Americans deserve to know that the medications and health products they are using are safe – whether it’s prescriptions from their local pharmacy, over-the-counter medications, or hand sanitizer,” said Senator Peters. “My commonsense bill would help protect Michiganders and people across the country from harmful or dangerous drug products by giving the FDA full authority to require companies to recall any unsafe drug product.”
Peters’ Safe Drugs Act would ensure that FDA’s public safety recalls protect all consumers by requiring companies to pull unsafe drug products from stores and pharmacies. While companies generally agree to recall their products, recent instances where voluntary recalls have not happened highlight the need for this legislation. In situations where companies refuse to comply with FDA’s request to recall an unsafe drug product, Americans’ health and safety are at risk.
Peters’ legislation grows out of findings from a report he issued last year that identified the consumer costs, public health risks, and national security threats posed by the United States’ reliance on foreign manufacturing of drugs produced outside of the United States.
Below are statements in support of Senator Peters’ legislation:
“Ensuring the safety of patients in Michigan hospitals has long been a key pillar of our work at the MHA. The Safe Drugs Act supports our mission-driven goal to provide only high-quality, safe care and drug products,” said Michigan Health & Hospital Association CEO Brian Peters. “The MHA applauds Senator Peters’ continued efforts to improve healthcare and, in this legislation, expand the FDA’s recall authority to drug products. When there is a harmful product on the market, the FDA must have the ability to swiftly mandate a recall to protect patients in all care settings.”
“Giving the FDA the authority to recall drug products is long overdue,” said American Society of Health-System Pharmacists (ASHP) CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “We applaud Senator Peters for taking action on this important reform to help ensure that patients receive safe drugs that improve health outcomes. Hospital and health-system pharmacists have consistently advocated for actions to continually improve drug safety, and for additional tools to help the FDA keep harmful products off the market. ASHP believes that the Safe Drugs Act is an important step in the right direction.”