Congress Letter to FDA Questioning Generic EpiPen Alternatives (MYL) (TEVA) (ADMP) (IPXL)
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Generic EpiPen makers are on watch after Energy and Commerce Committee leaders sent a letter to FDA Commissioner Dr. Robert Califf regarding generic drugs at FDA and ensuring we have a competitive prescription drug market.
The letter identifies a series of questions focused on the issues involved in bringing competitors to the EpiPen onto the market. The letter was sent by full committee Chairman Fred Upton (R-MI), Health Subcommittee Chairman Joseph Pitts (R-PA), and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA).
“In 2012, the Energy and Commerce Committee led the effort to pass the first generic drug user fee authorization (GDUFA) program,” wrote Upton, Pitts, and Murphy. “The goal of the legislation was to expedite the review of abbreviated new drug applications (ANDAs) and clear the backlog of applications at the agency. Improving the generic drug review process will promote competition and ultimately lower the cost of prescription drugs for America’s patients.”
“We are concerned about the lack of generic competition in the epinephrine auto-injector market,” continued the leaders, posing a series of questions about how FDA’s policies can inhibit competition in the generic drug market.
Last week, committee leaders raised concerns about the soaring costs of life-saving EpiPens. “EpiPens are a critical and often only option for saving kids from the brink of death during severe allergic reactions. And the soaring costs that patients are now facing for Epi-Pen Auto-Injectors is cause for alarm,” said Upton.
- Mylan (NYSE: MYL) EpiPen maker (announced generic today)
- Teva Pharma (NYSE: TEVA)
- Adamis Pharmaceuticals (NASDAQ: ADMP) (not generic but plans to offer epinephrine Pre-filled Syringes (PFS))
- Impax Laboratories (NASDAQ: IPXL) epinephrine auto-injector
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