News & Views

FDA Viewpoints on Approving Primatene® MIST

FDA officials considered medical, scientific, and consumer viewpoints

The Food and Drug Administration (FDA) is responsible for protecting public health, in part by assuring the safety and efficacy of prescription and over-the-counter (OTC) medicines. Two FDA officials have commented on the evaluation process used in approving Primatene® MIST for OTC use.

Primatene® MIST:

  • Was available over the counter for more than 50 years
  • Was removed from the market because it contained chlorofluorocarbons (CFCs)
  • Replaced CFCs with hydrofluoroalkanes (HFAs)
  • Received FDA approval on November 7, 2018
  • Is now the only FDA-approved asthma inhaler available without a prescription for the temporary relief of mild symptoms of intermittent asthma

Differing perspectives in the asthma community

FDA Commissioner Scott Gottlieb, MD, and the Director of the Center for Drug Evaluation and Research (CDER) Janet Woodcock, MD spoke about the need to consider different points of view. They carefully balanced the needs of underserved consumers who may not have access to asthma treatment with the needs of doctors who want to ensure that patients receive supervised care for their asthma.

For instance, the FDA heard from patients with mild asthma who had been using Primatene® MIST successfully and who objected when the asthma inhaler was removed from the market in 2011.


Primatene® MIST had been available over the counter for more than 50 years. The asthma inhaler was taken off the market because it contained chlorofluorocarbons (CFCs) that moved the asthma medicine out of the container. CFCs deplete the earth’s ozone layer. The new version replaces CFCs with hydrofluoroalkane (HFA), a substance that is permitted under current international and United States laws.

Concerns by some healthcare professionals

The FDA also heard from healthcare professionals who believed that patients with asthma could be harmed by self-medicating with an over-the-counter product. These professionals defined appropriate asthma treatment as regular and supervised care by a healthcare professional, which included the use of inhaled corticosteroids or other prescription-only medications to reduce inflammation and flare-ups.

Evaluating the evidence

Dr. Gottlieb and Dr. Woodcock consulted numerous experts and gathered new information to inform their decision about reintroducing Primatene® MIST. They weighed the risks and benefits of using an over-the-counter product to treat asthma and evaluated whether using such a product could delay treatment for people who needed long-term care from a healthcare professional for chronic asthma.

Considerations for approval

Dr. Gottlieb and Dr. Woodcock emphasized that one of the FDA’s priorities is to make sure consumers can access safe and effective medicines without a prescription so they have the power to address their medical conditions. The FDA officials said they discovered there was a proven need for an over-the-counter asthma inhaler.

In their review of Primatene® MIST, the FDA officials:

  • Discovered there was a proven need for an over-the-counter asthma inhaler
  • Commented that a critical consideration in approving Primatene® MIST was ensuring that consumers were able to understand how to use the asthma inhaler correctly
  • Said that the scientific information reviewed by their agencies showed that there are no serious safety concerns when Primatene® MIST is used as directed by consumers with mild symptoms of intermittent asthma

Consumer notes

Dr. Gottlieb and Dr. Woodcock cautioned that the recently approved Primatene® MIST is appropriate only for people with a diagnosis of mild, intermittent asthma. People with moderate or severe asthma should not rely on the over-the-counter inhaler. Primatene® MIST is not a replacement for prescription asthma treatments.

The FDA officials said they cannot stress enough that consumers should work with their healthcare professionals to ensure an appropriate treatment plan that works for each individual patient.