The pharma industry was hit with a pricing scandal earlier this month when it was revealed drugmaker Mylan had increased the price of the EpiPen – a life-saving allergy drug-device product – 17 times since 2007, or by a total of 548%.
The news came nine months after the industry fell afoul of the public and presidential candidates alike, when ‘pharma badboy’ Martin Shkreli hiked the price of the off-patent toxoplasmosis drug darapim to $750 per pill.
While Mylan has since announced it is launching a generic, cheaper version of the Epipen, the US Committee on Energy and Commerce has laid out its concerns about the lack of generic competition in the epinephrine auto-injector space in a letter to Food and Drug Administration (FDA) commissioner Robert Califf (letter embedded below).
“We must ensure that federal law and regulations are best tailored to promote a competitive prescription drug market,” the Congress committee said, adding that some of the policy issues surrounding Mylan’s EpiPen intersect with FDA generic drug regulations.
“In 2012, the Energy and Commerce Committee lead the effort to pass the first generic drug user fee authorization (GDUFA) program. 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.”
Questioning guidance
As such, the Committee calls on the FDA to provide it with answers to a number of questions focused on the numbers of epinephrine generics that have been submitted for review, and the Agency’s prioritisation of such filings before September 9.
The Committee also questions guidance published in June 2013 entitled: “Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products,” and asks the Agency whether any follow up guidelines are set to be released discussing specific factors a company should consider when referencing EpiPen in an ANDA.
Evercore ISI analyst Umer Raffat told in-Pharmatechnologist.com the FDA will respond to the information demand as the Agency is “always worried about safety.”
However, he said, “political pressure may play a role in improving the chances of generic approval this time,” and Teva and Antares Pharma will be likely to resubmit their generic EpiPen shortly after being knocked back earlier this year.