The Food and Drug Administration (FDA) authorized a generic version of EpiPen Thursday in response to the drug’s ballooning price as the agency continues to incentivize the pharmaceutical industry to make generics to reduce drug prices.
American drug company Mylan manufactures the anti-allergic reaction product, which can cost up to $600 for a pack of two, reported NPR. Teva Pharmaceuticals USA, which has an Israeli parent company, will be the first company besides Mylan to sell a “therapeutic equivalent” of EpiPen and EpiPen Jr. and is expected to be cheaper in the U.S.
“FDA has taken many steps, and will advance additional new policies, to make development of complex generics more efficient,” FDA commissioner Dr. Scott Gottlieb wrote on Twitter Friday. “We’re working hard to make it possible to bring more generic copies of complex drugs to the market. This is a high priority for FDA.”
#FDA has taken many steps, and will advance additional new policies, to make development of complex generics more efficient. We’re working hard to make it possible to bring more generic copies of complex drugs to the market. This is a high priority for FDA https://t.co/shFLmaNqCz
— Scott Gottlieb, M.D. (@SGottliebFDA) August 17, 2018
EpiPen is a prescription-only drug that most insurance companies cover, but even with insurance, Americans are paying about 25 percent more out-of-pocket for branded prescription drugs than in 2010, according to a 2016 IMS Health study.
In fact, an estimated 19 million adults in the U.S., or 8 percent of the population, say that they or a family member have illegally bought prescription drugs from outside of the U.S. to save money, according to a Kaiser Family Foundation study.
The FDA published a list of more than 200 drugs that are no longer patented yet do not have sufficient generic competition in late June.
The FDA approved several products in late August to be the first generic products to be granted a Competitive Generic Therapy designation, which aims to accelerate the development and review processes for generic versions of drugs that lack competition. (RELATED: FDA Approves First Generic Drugs For Fast-Track Review To Combat Overpriced Drugs)
The FDA’s June list of drugs without adequate generic competition includes medications for leukemia, severe bleeding, anxiety and malaria prevention.
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