Pharmaceutical

House seeks to give FDA authority to require recalls of dangerous OTC drugs

capitol dome 435x497 House seeks to give FDA authority to require recalls of dangerous OTC drugsA bill introduced in the U.S. House of Representatives will give the Food and Drug Administration (FDA) the authority to require manufacturers of over-the-counter (OTC) medicines to stop marketing unsafe products.

The Recall Unsafe Drugs Act, introduced by Rep. Rosa DeLauro (D-CT), would give the FDA the authority to wield its power over medicines and homeopathic products, closing up a loophole that currently allows companies to refuse the FDA’s request that they remove products from the market if they are deemed unsafe.

For example, last month the FDA asked Standard Homeopathic Company to recall its Hyland’s homeopathic teething gels and tablets for infants and children because they contained inconsistent levels of belladonna that could be harmful. The agency had received reports of shortness of breath, tremors, seizures and deaths in babies who had used the teething products. However, the company refused to issue a recall.

“Hyland’s refusal to recall its teething tablets, despite numerous health and safety warnings from the FDA, is downright shameful. While the FDA has called on consumers to stop using the products, Hyland’s will not go above and beyond what the law requires and is choosing instead to prioritize the company’s profits and reputation before the safety of children,” said DeLauro, ranking member on the House Labor, Health and Human Services, and Education Appropriations Subcommittee.

“There is absolutely no reason why a potential life-threatening product should be in our families’ homes where unsuspecting parents may give it to their children. As it stands, the FDA would have to go through an arduous legal process to take action against manufacturers such as Hyland’s. This is unacceptable and threatens the health and safety of American families. The Recall Unsafe Drugs Act will enable the FDA to step in and issue a mandatory recall of drugs that have been found to cause serious health consequences or death.”

Currently, the FDA can only mandatorily recall infant formula, medical devices, tissue products, and biologics.

Source: Regulatory Affairs Professionals Society