House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

Regulatory NewsRegulatory News | 16 February 2017 |  By 

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

The Recall Unsafe Drugs Act would give FDA mandatory recall authority over drugs and homeopathic products. The agency confirmed to Focus that it does not have that authority.

The loophole is problematic in that some companies can refuse FDA’s calls to remove their pharmaceuticals from the market because they are unsafe.

Last month, FDA contacted Los Angeles-based Standard Homeopathic Company, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. But the company has not agreed to conduct a recall.

FDA’s recent findings showed Hyland’s teething tablets contain elevated levels of belladonna, which has been linked to more than 400 adverse event reports in children including death, seizures, shortness of breath and tremors.

“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,” DeLauro added.

As FDA’s guidance from 2003 notes, the agency can only mandatorily recall infant formula, medical devices, tissue produts and biologics.

“Certain statutory provisions authorize mandatory recalls of infant formula (21 USC § 350a(e)-(g)), medical devices (21 USC § 360h(e)), and human biological products (42 USC § 262). Additionally, FDA regulations set forth specific requirements for mandatory infant formula recalls (Subpart E of 21 CFR Part 107), medical device corrections and removals (21 CFR Part 806), and mandatory human tissue recalls (Subpart D of 21 CFR Part 1270). In addition to the requirements in these statutory provisions and regulations, the guidance's specific recommendations would also apply to these types of recalls. In the context of a mandatory recall, those conditions in the guidance that are already set forth in a statute and/or regulation would be requirements, rather than recommendations, under the applicable statute and/or regulation,” the guidance says.

The nonprofit Public Citizen offered its support for the bill, noting in a statement: “Most people would be shocked to learn that while the FDA has the authority to order a recall of medical devices and biologic products, such as vaccines and blood products, the agency cannot order recalls of prescription and over-the-counter medications. DeLauro.”


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy