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US Senator Introduces Bill to Give Broader Authority to FDA Concerning Dangerous Drugs

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

U.S. Senator Gary Peters (D-MI), 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.

As a federal regulatory agency, the FDA is responsible for consumer safety but is often hamstrung when it comes to dealing with drugs that injury or kill consumers. 

“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.”

The pharmaceutical lobby in Washington is powerful and will undoubtedly fight this legislation.  Even when a drug is deemed unsafe for consumers, the drug companies still make huge profits prior to a drug’s removal from the marketplace. 

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.

Even the manner in which a drug is approved for market in the United States heavily favors the interests of the pharmaceutical industry.  It is high time that the government ensure that pharmaceutical companies take fiduciary responsibility as corporate citizens and protect the public from dangerous drugs. 

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