One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy. Part of this access includes the availability of safe and effective nonprescription, over-the-counter (OTC) medications that can help empower consumers to address medical conditions.
In order for a product to be approved by the FDA for OTC use, we make sure the product receives a robust scientific review to ensure it can be used safely by patients. While OTC medicines play an important role in public health, with certain OTC medicines, there comes a more complex need to make sure that consumers understand how to best use the product to manage their health as OTC medicines are not one-size-fits all.
We’ve made expanding access to OTC products a high priority and have worked on new legislative and policy proposals to promote access to safe and effective OTC drugs. Yesterday the FDA approved a new version of Primatene Mist, the only OTC metered-dose inhaler. This product has been the subject of past and current interest by patients and providers, and we want to take this opportunity to address some of the considerations that went into this approval, and the risks and benefits that inform the product’s proper use.
Primatene Mist is approved by the FDA to provide temporary relief for symptoms of mild, intermittent asthma. This OTC drug is approved only for those who have been diagnosed with asthma by a health care provider. Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It’s important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a health care professional.
Some may remember the former OTC Primatene Mist that was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. This new version contains hydrofluoroalkane propellants, which are permitted under current international and U.S. law. Prescription-only inhalers that use different medications, such as albuterol and levalbuterol, also use HFAs as propellants. When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product. Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment. At the same time, we also heard from practitioners concerned with the product remaining on the market. They believed asthma patients could be harmed by self-medicating with an OTC product and that appropriate asthma care included regular care and supervised care by a health care provider, including the use of inhaled corticosteroids or other controller medications to reduce inflammation and the incidence of exacerbations. There were a complicated set of issues informing these differing views.
We’ve taken measure of all of these considerations in discussing the benefits and risks of using an OTC product for the treatment of asthma and evaluating whether use of an OTC product could potentially forestall treatment for people who needed long-term care for chronic asthma from a health care provider. We have heard from experts and gathered new information to inform our current view on these questions.
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