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Choosing medications and medical devices

Ever wonder how the FAA makes a decision about approving a medication?

The FAA does not review every medication that comes on the market. It will wait until airmen or the pilot advocacy organizations (AOPA, the Experimental Aircraft Association, etc.) begin to ask about a particular medication or if their consultants recommend it consider a newer medication. The FAA will not consider a medication or a new medical device (generally this means a device that is permanently inserted into the body) until it has been approved by the Food and Drug Administration (FDA) and on the market for one year. When a medication first is released it has undergone studies on lower numbers of people who agree to be test subjects. Once a drug has been reviewed and approved by the FDA, the pharmaceutical companies will advertise the medication and it becomes relatively more widely used. The FAA wants to see what aeromedically relevant side effects are then noted before it even begins to review the medication for acceptance in pilots. To continue reading…

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Dr. Warren Silberman is the former manager of FAA Aerospace Medical Certification and a doctor of osteopathic medicine. A pilot since 1986, he is recognized nationally as an expert in aerospace/preventative medicine, and is a regular writer for AOPA’s Pilot Protection Services.