Amendment to BPCIA Would Require FDA to Keep Reviewing Insulins Submitted Through NDAs

Kelly Davio

Senator Dick Durbin, D-Illinois, said that the “termination cliff” on the transition date creates a “perverse incentive that could delay approval” for biosimilar insulins, and said that the new legislation would create a faster approval path for lower-cost products.

The Biologics Price Competition and Innovation Act (BPCIA) states that biologics that were originally approved through New Drug Applications (NDAs) under the Federal Food, Drug, and Cosmetic Act—such as insulins—will be deemed to be licensed as biologic products under the Public Health Service Act at the end of a 10-year transition period that closes on March 23, 2020.

As part of that transition, according to the FDA’s final guidance on the matter, any NDAs for transition products that are pending a decision on March 20, 2020 will receive Complete Responses. The FDA has indicated that these applications will have to be resubmitted via pathways for novel biologics or for biosimilars.

However, there has been concern that this approach by the FDA will lead to a “regulatory dead zone” in which insulin products will see delayed approval.

This month, a new item of legislation was introduced to address that potential problem. S.2103, or the Affordable Insulin Approvals Now Act, would amend the BPCIA to require that insulins with filing dates not later than December 31, 2019, would continue to be reviewed and approved under section 505 of the Food, Drug and Cosmetic Act, even if the review and approval process were to continue past the March transition date. These drugs would be deemed to be licensed as biologics effective on either the transition date or the date of approval, whichever comes later.

The bill was introduced by Senators Dick Durbin, D-Illinois, Kevin Cramer, R-North Dakota, and Tina Smith, D-Minnesota. In a statement, Durbin said that the “termination cliff” on the transition date creates a “perverse incentive that could delay approval” for biosimilar insulins, and said that the legislation would create a faster approval path for lower-cost products.

The legislation has received support from the Diabetes Patient Advocacy Coalition, the National Diabetes Volunteer Leadership Council, and Children with Diabetes.

This bill is part of a spate of action from law makers indented to address the problem of skyrocketing insulin costs. Also introduced this month was another bill targeting insulin: the Insulin Price Reduction Act. The bill would prohibit pharmacy benefit managers (PBMs) and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels. To retain the rebate restriction in the next year, increases in the insulin’s list price must not exceed inflation. The rebate restrictions would apply to all private insurance plans and Medicare Part D plans.

In addition, the bill would require that PBMs and insurers waive the deductible for private insurance plans for any insulin that meets the list price reduction requirements each year.