The administration points to statutory language, including definitions amended by the ACA, as preventing that FDA from allowing states to import biologics.
A proposed rule unveiled Wednesday that lays the groundwork to allow the importation of certain drugs could help to make medicine more affordable for the American public in the foreseeable future, according to the Trump administration.
But the proposed pathway that would allow states and other non-federal government entities to ask the Food and Drug Administration to review and authorize their importation plans—perhaps with a pharmacist, wholesaler, or other entity as a cosponsor—excludes biological products.
That means any programs these entities devise won't be allowed to import a product that's vital for many diabetics: insulin.
Buyers won't be allowed to import insulin under this proposal because of the way the relevant statute is worded, an FDA spokesperson tells HealthLeaders:
- A section of the Federal Food, Drug and Cosmetic Act defines what an importable "prescription drug" is;
- That definition specifically excludes "a biological product," as defined by a provision of the Public Health Service Act;
- The PHS Act was amended by the Affordable Care Act to include the term "protein" in the definition of a biological product; therefore,
- The FDA has since 2010 considered insulins and other protein products to be biological products, the FDA spokesperson says.
Although insulin would be ineligible for the buyer-led pathway of this drug importation proposal, the administration also outlined a seller-led pathway that would allow manufacturers to import their own insulin products. That second proposed pathway, which was outlined in draft guidance released Wednesday alongside the proposed rule, would apply to insulin and certain other biologics, the FDA spokesperson confirms.
The guidance would give drug makers a procedure by which to obtain an additional National Drug Code (NDC) and use it "to basically compete against [their] own product but at a lower list price," said Health and Human Services Secretary Alex Azar.
This pathway wouldn't be the first or only way an insulin manufacturer could voluntarily undercut its own price point. Amid public outcry over price hikes, Indianapolis-based Eli Lilly & Co. announced earlier this year that it will sell a half-price "authorized generic" version of its brand-name insulin Humalog. At about $137 per vial, the generic costs roughly the same as brand-name Humalog did in 2012, as Kaiser Health News reported.
Overall, the cost of insulin has risen dramatically in recent years, fueling public outrage over price hikes and the lack of transparency around prescription drug rebates. The annual insulin cost incurred by an average patient with Type 1 diabetes nearly doubled in a recent five-year period, from $2,864 in 2012 to $5,705 in 2016, excluding rebates, according to a 2019 report by the nonprofit Health Care Cost Institute (HCCI).
That increase in gross spending on insulin was driven primarily by insulin price hikes, though rising popularity of more expensive insulin products also contributed, the HCCI researchers said, as Reuters reported.
The proposal drew a quick rebuke from both the pharmaceutical industry and the pharmaceutical industry's critics.
Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the proposal a potentially dangerous "political maneuver."
Steven Porter is an associate content manager and Strategy editor for HealthLeaders, a Simplify Compliance brand.