Legislation introduced by Sen. Gary Peters (D-MI), ranking member of the Homeland Security and Governmental Affairs Committee, would grant the Food and Drug Administration (FDA) authority to force drug recalls instead of just recommending companies remove their products, Law360 reported.
A recall is a method of removing or correcting products that violate the laws administered by the FDA. It is currently a voluntary action on the part of drug manufacturers and distributors to protect the public health and well-being from products that present a risk of injury or are otherwise defective. The FDA can recommend that a pharmaceutical company recall a drug, and most do. But some refuse. In some of those cases, the FDA has issued warnings to the public not to use a particular product. For example, the FDA has warned consumers not to use about 165 hand sanitizers because they contain a toxic ingredient.
However, the FDA does have the authority to force recalls of medical devices and vaccines.
“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 said. It’s not the first time lawmakers have floated legislation to increase the FDA’s authority over drug products. In January, Rep. Rosa DeLauro (D-Conn) reintroduced similar legislation.
“Ensuring the safety of patients in Michigan hospitals has been a key pillar of our work at the MHA,” said Brian Peters, CEO of the Michigan Health & Hospital Association (MHA). “The Safe Drugs Act supports our mission-driven goal to provide only high quality, safe care and drug products.”
Lawyers in our Mass Torts section handle litigation related to defective medical devices and dangerous drugs, including products and drugs that have been recalled from the market. Among the cases we are working on now is the popular heartburn medication Zantac, which was recalled for increased cancer risk, and defective bone cement often used in knee replacement surgeries. For more information about these and other cases involving prescription and over-the-counter (OTC) drugs and devices, contact Melissa Prickett, Director of the Section.