Tuesday, August 02, 2022

FDA Moves to Expand NDC Numbering to Accommodate Rapid Rise in "Authorized Generic" Drugs

On July 22, 2022, the U.S. Food and Drug Administration ("FDA") announced a proposed new rule (see https://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements for the announcement in the Federal Register, or the FDA's own page on the announcement at https://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format, effectively Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to minimize the impact of the FDA running out of ten-digit national drug codes (NDC's) by adopting a single, uniform 12-digit format for FDA-assigned NDC's. In other words, its expanding the NDC numbering system from 10-digits to 12-digits.





In recent years, because of the manner in which vertically-integrated (with commercial healthcare insurance companies) Pharmacy Benefit Managers ("PBM's") aggregate Rx rebate dollars (forcing drug list prices to INCREASE as a result), FDA has seen many drug manufacturers respond by introducing so-called "authorized generic" products (the FDA defines an "authorized generic" as exactly the same product as an approved branded drug, but is marketed without the brand-name on the label) in an effort to try and bypass the impact of PBM rebating which puts upward pressure on drug list prices, and make the "authorized generic" drug products more affordable.

People with diabetes have benefited directly from the dual branded/unbranded strategy.  





In March 2019, Eli Lilly & Company, Inc. announced it was introducing an unbranded prandial insulin analogue identical to brand-name Humalog. Rival Novo Nordisk announced a nearly identical plan to introduce Novo Nordisk Insulin Aspart Injection U-100 in September 2019. Sanofi followed suit three years later when it formally announced the launch of Winthrop US by Sanofi Insulin Glargine U-100 earlier this year, and offered coupons for patients to buy any Sanofi insulin for a price of $35/vial (exactly the same price as Lilly Insulin Lispro Injection U-100 now sells for with a manufacturer coupon). Even biosimilar makers are selling branded/unbranded products. Biocon (and current U.S. partner Viatris) sell both the interchangeable (with Sanofi Lantus) glargine product branded as Semglee, and a separate NDC number which sells for 65% less called Viatris Insulin Glargine Injection U-100.

To be sure, the dual branded/unbranded strategy has proven to be a very effective method of reducing patient out-of-pocket costs. This is particularly true on very heavily-rebated classes of drugs like insulin.

For example, Novo Nordisk A/S revealed in the company's 2021 Annual Report that the company's insulin affordability offerings in the U.S. had reached "more than 1 million people" in 2021. 






Rival Sanofi revealed that Sanofi's recently modified "ValYOU" coupon program was "Used more than 97,000 times, providing more than $37 million in savings to people living with diabetes" in the U.S. during 2021. And, that was before the company reduced its insulin prices from $99/vial to $35/vial.







Meanwhile, Lilly revealed to investors that since Lilly introduced its unbranded insulin lispro product in late 2019, its unbranded insulin called simply Lilly U-100 Insulin Lispro Injection now accounts for nearly 1/3 of the company's total U.S. Humalog sales (and that shift has occurred in less than 3 years on the market). In fact, that shift on Humalog to Lilly Insulin Lispro required virtually no marketing, no army of salesmen/saleswomen calling on doctors offices and no costly TV ads.





To be sure, insulin-makers aren't the only ones introducing less costly "unbranded" prescription drugs. We are seeing it happening in countless therapeutic classes of prescription drugs. FDA maintains a listing of "authorized generic" drugs HERE. For example, there are "authorized generic" versions for erectile dysfunction meds, depression meds and more. All told, there are currently nearly 2,000 "authorized generic" medicines now on the market. They have become popular with manufacturers because it's a way of extending the product lifecycle for now patent-expired drugs without ceding sales to generics.

As a result of this uniquely American problem in prescription drug affordability, the number of identical drugs with different NDC numbers has grown quite rapidly. The FDA hopes that by expanding the numbering system it can accommodate the demand for new NDC numbers.

I certainly support the FDA's efforts to accommodate the rapid growth in authorized generic drugs. I only wish it wasn't a necessity.

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