Legislation Would Give FDA Mandatory Authority To Recall Drugs

Image courtesy of Steven Depolo

Last month, the Food and Drug Administration confirmed that it had found varying and elevated levels of a potentially deadly toxin in teething tablets sold under the Hyland’s brand. Despite the dangers posed by the tablets, the FDA couldn’t order a recall of the products — and the manufacturer refused to. But that could change in the future, as recently introduced legislation would give the agency the authority to order mandatory recalls of drugs and homeopathic products. 

Connecticut Rep. Rosa DeLauro on Thursday introduced the Recall Unsafe Drugs Act that would revise the FDA’s ability to issue mandatory recalls for products it doesn’t directly regulate.

Under the proposed legislation, the FDA would be able to step in and issue a mandatory recall of drugs that have been found to cause serious health consequences or death.

Currently, the FDA has mandatory recall authority over other products that the agency regulates, such as medical devices, food, and biological products. But in order to recall drugs or homeopathic products, the agency would have to go through a legal process to take similar actions.

Additionally, if something were to go wrong with the drugs or product, the FDA must rely on the good faith of drug manufacturers to recall their products, DeLauro notes.

While some drug manufacturers follow the FDA’s guidance and recall problematic or dangerous products, others do not.

Such was the case recently with Standard Homeopathic Co., the manufacturer of the Hyland’s teething tablets, which were found to contain varying and elevated levels of belladonna, a plant that contains potentially deadly toxins.

At the time the report was released on Jan. 27, the FDA said it had compiled numerous incidents of children reacting negatively to Hyland’s teething products. These include everything from complaints about red, bumpy rashes, to children suddenly appearing listless, to multiple reports of seizures.

While Hyland’s announced in Oct. 2016 that it would stop selling the teething products in the U.S., many stores may still have the inventory in stocks, continuing to pose a danger to children. At the time of the FDA’s report, Hyland’s had refused to recall the remaining products.

Instead, the FDA issued a warning that the products “pose an unnecessary risk to infants and children” and is urging consumers to not use them.

“This is unacceptable and threatens the health and safety of American families,” DeLauro said in a statement referring the inability of the FDA to require a recall.