WRITTEN BY: Todd Boudreaux
On July 11, 2019, U.S. Senators Dick Durbin (D-IL), Kevin Cramer (R-ND), and Tina Smith (D-MN) introduced the Affordable Insulin Approvals Now Act , a bipartisan bill to speed up the approval process of generic insulin products in order to help lower costs of the life-saving drug.
In December 2018, then-FDA Commissioner Scott Gottlieb, M.D., released a statement detailing a handful of new guidances designed to increase competition and bring down prices across the insulin market, slated to take effect in 2020.
Though these guidances were meant to increase competition, they had the unintended consequence of potentially slowing down approval of generic insulins currently in production. According to a press release by Durbin’s office, the FDA’s “new guidance effectively creates an application termination cliff on March 23, 2020 — in which the FDA will automatically reject ‘generic’ insulin products that are in the approval pipeline during that time. As a result, this could delay approval of lower-cost insulin products for American patients.”
This new bill aims to fix this “termination cliff” by requiring the FDA to continue reviewing generic insulin applications after the agency’s currently planned March 2020 cut-off date.
In March 2019, Lilly Diabetes announced that they were releasing an authorized generic version of Humalog — Insulin Lispro — for half the list price of Humalog. Insulin Lispro is now available in pharmacies across the United States, and is viewed as the first of what could be several generic insulins coming to market over the next few years.
“More generic insulin in the market means lower costs for those in need. Our bill encourages competition and free market solutions to the rising cost of this life-saving drug,” said Cramer. The legislation is supported by Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.
This bill comes on the heels of another insulin pricing bill introduced by Senators Smith and Cramer. Just two weeks earlier the pair announced the ‘Emergency Access’ Bill to lower insulin costs. That legislation features the set-up of an emergency insulin assistance program, which would be funded in part by a fee imposed on insulin manufacturers who raise prices more than 10% in a year.
The introduction of these bills is a positive step at a time when insulin pricing is under more scrutiny that ever. It remains to be seen however — if and when these bills are enacted — what the real-world effects will be.
Earlier this week, the Trump administration withdrew their support of the “rebate rule”, a proposal touted for months that would help lower insulin costs for some. If passed, Medicare and Medicaid recipients would have seen rebates added into the upfront or “list price” of insulin, lowering what they pay at the pharmacy counter. These rebates are currently going to Pharmacy Benefit Managers (PBMs) who negotiate the prices between insurance companies and drug manufacturers.