As insulin prices rise, America’s more than 30 million diabetics struggle to find affordable alternatives, says U.S. Rep. Mike Kelly (R-PA).
“Access to affordable insulin is a public health imperative,” Rep. Kelly wrote in a July 16 letter sent to Dr. Norman Sharpless, acting commissioner of the U.S. Food and Drug Administration (FDA). “American diabetics, tens of thousands of whom live in Pennsylvania’s 16th Congressional District, would benefit from the availability of a generic insulin.”
Rep. Kelly, a member of the Congressional Diabetes Caucus who himself has diabetes, noted in his letter that increasing insulin prices are partly to blame for a lack of generic insulin on the commercial consumer market.
“The average annual cost of insulin for a person with type 1 diabetes has reached $5,705, a 600 percent increase since 2001,” the congressman wrote. “Reportedly, this has led to approximately 25 percent of diabetics rationing their doses because they cannot afford refills of their prescriptions.”
Rep. Kelly also wrote that “the regulatory pathway for generic insulin production is currently inhibited” and he wants to know why.
He asked Dr. Sharpless to promptly address why the FDA did not include insulin in its 2017 guidance on abbreviated new drug applications for certain peptide drug products. “Please note if there are safety, efficacy, or statutory barriers to its inclusion,” he wrote.
The lawmaker also asked that if the FDA’s 2017 guidance exclusion of insulin was due to statutory limits, what legislative action is now required to reverse that obstacle.
Rep. Kelly’s office explained that under the Biologics Price Competition and Innovation Act of 2009, insulin will be reclassified as a biological product in 2020. As a result, insulin will be taken off the FDA’s list of approved drug products, meaning that manufacturers will not be able to obtain approval for generic insulin even if they are in the approval pipeline prior to 2020. After the transition, companies will need to apply to make generic insulin under a new application process.