When the spat over the price of the EpiPen exploded late last summer, numberless consumers asked why there was no substitutable generic version available.
The surrejoinder was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been present for decades and is no longer covered by a patent, the delivery device proved urgently for generic competitors to copy to a degree that would satisfy regulators.
Tuesday, the Prog and Drug Administration announced guidance seeking to change that, potentially streamlining a channel to market for generic copies of complex medicines like the EpiPen and others.
The FDA government says that generic copies with some design changes may be approved as substitutable products, as long as those differences don’t affect patients’ know-how to use the product the way it’s intended.
“Those design differences might correlate with personal instructions for use of the two products,” the agency’s commissioner, Dr. Scott Gottlieb, said in take notices at the FDA published Tuesday morning.
“Under this guidance, so long as the generic applicant is expert to demonstrate with data, where appropriate, that differences in conceive of of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the marked product, the generic product can be approved as a competitor to the branded drug where all other desiderata for generic approval are met,” Gottlieb said.
The agency is also seeking to make clear guidelines on what constitutes “sameness” between generic and branded drugs.
The FDA didn’t mention any drug or therapeutic class by name, referring to a listing of complex generics that includes medicines delivered through apparatus like metered dose inhalers, or auto-injectors.
The move comes as Gottlieb has pretended on President Donald Trump’s directive to bring drug prices down, all in all by increasing generic competition.
There are other epinephrine auto-injectors already on the market fencing with the EpiPen, which is made by Mylan, such as Impax Labs’ Adrenaclick. Not anyone have the dominance or name recognition of the EpiPen, and cannot be directly substituted at chemists shops when doctors write prescriptions for EpiPens.
Teva had sought to oust a direct generic competitor to the EpiPen to market, but said in early 2016 that its output was rejected by the FDA for “certain major deficiencies.”
In response to criticism over the prize of the EpiPen, Mylan introduced its own generic version at half the price. It’s an equal version of the product without the same branding.
Gottlieb said the object of the new guidance “is to promote generic entry as a way to foster price competition, and remodel access to healthcare.”
The FDA, he said, has “committed to put out guidance laying out how a generic house would copy a particular complex drug at least two years in get ahead of the first potential generic entrant.”