Part of the ACA’s sweeping healthcare reform was the Biologics Price Competition and Innovation (BCPI) Act of 2009, which re-classified certain drugs that had previously been regulated under the Food, Drug and Cosmetic Act. Insulin, for example, has historically been treated as a drug product, but will be classified as a biological product (and, therefore, governed by the Public Health Service Act) starting on March 23, 2020. Since classification of a pharmaceutical significantly impacts the pathway for the marketing of corresponding generics, this shift in characterization is significant for insulin users. The proposed Market Access for Generic Insulin Competition (MAGIC) Act of 2019 hopes to avoid regulatory delays—and increase the availability of generic insulin—by establishing a permanent ANDA approval process. See H.R.4244, 112th Cong. (2019).
Insulin is used by 7.4 million million people nationwide and has steadily increased in price since 1996. Despite vast demand, the FDA issued guidance in 2017 specifying that insulin was not eligible for approval as a generic through the established ANDA process. Because insulin appears to fall within the agency’s definition of “peptide drug,” its exclusion has been a source of confusion for many commentators. One lawmaker, Representative Mike Kelly (R-Pennsylvania), wrote a letter to the FDA requesting an explanation of why insulin was omitted from the 2017 guidance document, but no response has been provided.
At present, it is unclear exactly what the biosimilar approval process will look like. The FDA has issued guidance documents, but questions remain regarding how an applicant can prove biosimilarity. Because of this uncertainty, Congressman Kelly—a sufferer of diabetes himself—introduced a bill in late September designed to create a shorter and clearer approval process for generic versions of insulin. Under the proposed MAGIC amendment, generic insulin manufacturers would be able to utilize the existing ANDA pathway. If this legislative initiative fails, insulin will be removed from the Orange Book in March of 2020, and new applicants will be barred from relying on these prior applications to expedite generic approval. Instead, would-be manufacturers of insulin products could obtain approval only as “biosimilars,” subject to the uncertainty of the BCPI.
Proponents of the MAGIC initiative urge that utilizing the existing ANDA process will result in a faster approval, and therefore a faster marketplace presence. They believe that this could help circumvent the dangers of insulin rationing, which presents a life-threatening risk to diabetes sufferers. Ultimately, as the BPCI’s March 2020 drug re-classification looms and the MAGIC proposal is considered, drug companies should be mindful of an impending overhaul of the insulin market—one way or another.