Congressional Diabetes Caucus Looks to Codify FDA's Insulin Transition Guidance

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.
Allison Inserro
April 04, 2019
The bipartisan co-chairs of the Congressional Diabetes Caucus introduced a bill this week to make permanent new FDA guidance on the transition of insulin to regulation as a biologic. The bill is aimed at preventing a future executive branch of government from trying to revoke the policy.

Representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, introduced the legislation.

“We know that one of the best ways to reduce the cost of insulin is to increase competition,” DeGette said in a statement. “Despite insulin being available for nearly 100 years now, there are still only [3] companies that manufacture the drug here in the U.S. and only [1] generic version of the drug available to consumers.”

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act (BPCIA). The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

The FDA guidance discusses how the agency plans to transfer drugs previously approved under new drug applications (NDAs) to biologic license applications (BLAs) in March 2020 as part of the Biologics Price Competition and Innovation Act. The guidance makes clear that NDAs transitioning to BLAs will not gain an additional 12 years of patent exclusivity because of the switch.

The need to codify the guidance comes as industry groups, such as Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Association, as well as other biopharma companies, are raising questions and concerns about how the FDA has interpreted the law in terms of reference product exclusivity.

On Tuesday, DeGette chaired a meeting of the Oversight and Investigations subcommittee, part of the Committee on Energy and Commerce, and heard testimony about how the high price of insulin is forcing patients with diabetes to skip doses or go without.

In other insulin cost news this week, Cigna and its pharmacy benefit manager Express Scripts said they are launching a program for patients enrolled in commercial plans so that they pay no more than $25 for a 30-day supply of insulin.

In a statement, the companies said the average out-of-pocket cost for insulin was $41.50 for a 30-day supply last year; under the new program, eligible patients will save approximately 40%. “In most cases, people who use insulin will see lower out-of-pocket costs without any increased cost to the plan,” the companies said.

A company spokeswoman told The American Journal of Managed Care®, a sister publication of The Center for Biosimilars®, that a complete list of products is not yet available, but that the companies are planning to have “all forms of insulin” (short acting, basal, and intermediate) available at the lower price.

The program is not available to people enrolled in government health plans.
 

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