FDA Proposes Using a Public-Health Lens When Considering New Product Approvals

Pear in Mind: A Blog in the Public Interest

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In June 2017, a year that saw nearly 70,000 deaths from drug overdoses in the U.S., the Food and Drug Administration requested the removal of an opioid pain medication called Opana ER from the market. This request marked the first time that the agency had removed a currently marketed opioid pain medication from sale due to its “public health consequences”––a shift to injection use and an outbreak of HIV. However, a little-noticed but important draft guidance issued by the FDA in September of this year suggests that more decisions based on public health considerations could be coming.

Under current agency interpretation of the Food, Drug, and Cosmetic Act, the FDA does not need to include public health considerations in its risk and benefits analyses for product approvals, because the law only requires the agency to consider whether a new product is safe and effective “under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” Narrowly interpreting this language, the FDA may consider only the risks and benefits for groups of individual patients who receive a drug through a doctor’s prescription, thus excluding improper use and diversion of the drug to people to whom it was not prescribed.

But, according to the FDA’s new draft guidance on how the agency will approve drug and biological products, “In certain circumstances, such as in the review of drugs to diagnose and treat communicable diseases or drugs identified as controlled substances, FDA’s benefit-risk assessment incorporates broader public health considerations for both the target patient population and others, such as risks related to misuse, accidental exposure, or disease transmission.”

This shift towards a broader, more public-health-based approach is a promising one, as Dr. Josh Sharfstein and I wrote in a Viewpoint for JAMA recently. It signals that the FDA intends to align its regulatory powers more fully with its mission to protect public health.

The implications of these expanded benefit-risk assessments go beyond prescription opioid drugs like Opana ER. For example, the FDA may consider the public health consequences of antibiotics, whose overuse promotes antibiotic resistance, or vaccines, whose use affects not just vaccine recipients but the larger community as it strives to reach herd immunity.

Incorporating public health considerations into product approvals also aligns with FDA’s practice in other areas of regulation. Earlier this year, when the FDA evaluated the marketing of e-cigarettes, the agency considered the risks and benefits not only for adults trying to quit smoking but also for young people who may potentially start using e-cigarettes and become addicted. As a consequence, FDA authorized the product for marketing only when accompanied by requirements to reduce youth exposure.

Of course, this new public health direction will also require some changes at FDA. The agency should recruit staff with expertise in assessing population health consequences of policy decisions and refer certain benefit-risk assessments to public advisory committees and for independent review. To maximize public trust, especially in this introductory period, transparency is essential.

Between 1999 and 2019, nearly 500,000 people died from an opioid overdose, and the epidemic has been a painful reminder that the risks and benefits of a drug affect not only patients but families and communities as well. Moving forward, the new FDA guidance for product approvals will allow the agency to consider real-world implications––for individuals and the public.

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