Pharmaceutical companies may find FDA with more power to pull drugs

Erin McCallister Senior Manager, Health Research Institute, PwC US July 23, 2020

The House Appropriations Committee approved a 2021 FDA funding bill that would allow the federal regulatory agency to remove certain drugs from the market rather than rely on voluntary recalls from companies. The bill would let the FDA mandate recalls of drug products—both prescription and over the counter—that have been found to cause serious health effects or death.

The FDA has authority to mandate recalls of medical devices and biologic products such as vaccines. However, under its existing authority, the agency can only request that manufacturers withdraw unsafe drugs from the market.

Rep. Rosa DeLauro, D-Conn., has been advocating the expansion of the FDA’s recall authority to drugs since 2017, reintroducing a bill with this language in January.

“As people work to protect themselves and their family during the COVID-19 pandemic, it is troubling that FDA lacks the ability to mandate recalls of dangerous products, like contaminated hand sanitizers,” DeLauro said in a statement after the funding bill cleared the committee.

She was referring to the FDA’s June request to a manufacturer to remove hand sanitizers that were tainted with toxic methanol and issue a voluntary recall. While the company did not take immediate action, the hand sanitizers were eventually recalled. The FDA has since issued a warning about hand sanitizer products that contain methanol.

The bill also proposes a $41 million bump in funding for the FDA, to $3.21 billion. The extra money is earmarked for advancing influenza vaccine manufacturing, improving food and medical product safety, developing a framework for the regulation of CBD products, and increasing the safety and cybersecurity of medical devices.

HRI impact analysis

While the recommended recall of hand sanitizers is a potential byproduct of the FDA’s swift deregulation to respond to the COVID-19 pandemic, the agency’s overall track record for recalls is almost on par with or slightly below the same period in the prior two years.

Through July 20, the agency has announced 58 drug recalls, including over-the-counter products, compared with 14 recalls for medical devices and none for biologics this year. During the same period in 2019 and 2018, the FDA issued 63 and 79 drug recalls, respectively.

Medical device recalls have been far fewer. Thus far in 2020, the agency has issued just 14 recalls, but the number was even smaller during the same period in 2019 when seven medical devices were recalled. For 2018, that number was 14.

In the past three years, the FDA has recalled just one biologic product.

In 2019, the FDA issued multiple guidance documents to assist industry with the voluntary recall process in which the agency outlined the steps companies should take to investigate any potential safety or quality issues, notify the FDA and quickly recall the product through the supply chain.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

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Ingrid Stiver

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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