Last week, the new FDA Commissioner, Scott Gottlieb, MD, took steps to increase competition in the prescription drug market and increase access to generics. First, the FDA published a list of off-patent, off-exclusivity branded medications without approved generics. The purpose of this action was to encourage submission of abbreviated new drug applications on medications off patent where there is no competition. This would likely ensure that no one pharmaceutical company could have a monopoly on one of these drugs, which could lead to high costs for the patient. (Remember Turing Pharmaceuticals, which raised the cost of Daraprim – a life-saving medication for AIDS – by 5,000%?)
Upon reviewing the list for specific medications, I found some agents that allergists may prescribe: acrivatine, an oral antihistamine, emedastine, a topical antihistamine for allergic conjunctivitis, and loteprednol, a topical corticosteroid for allergic conjunctivitis. Methacholine which is used for bronchoprovocation studies is also found on the list.
The other step undertaken by the FDA, which may be more important for all our allergy patients, is a new policy to expedite the review of generic drug applications. The FDA will accelerate the review of these applications until there are three approved generics for a given drug product. You may be asking: why three approved generics? Because significant price reductions are not usually seen until there are multiple FDA-approved generics available.
On making these announcements, Commissioner Gottlieb said, “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require. Getting safe and effective generic products to market in an efficient way, being risk-based in our own work and making sure our rules aren’t used to create obstacles to new competition can all help make sure that patients have access to more lower-cost options.”
While in Washington DC last April, I was able to attend part of the hearing of the Senate Committee on Health, Education, Labor, and Pensions for Dr. Gottlieb to become FDA Commissioner. There was major concern from several Senators that his previous financial and professional ties to the pharmaceutical industry would hamper his ability to be an effective commissioner. It’s clear from these announcements that he is taking independent actions, and that he is moving the FDA in the right direction. It’s an important step that’s great for us in the field of allergy and, more importantly, for our patients.
Michael Blaiss, MD, FACAAI, Executive Medical Director