AG Racine Urges FDA To Stop Orange Book Patent Listings That Prevent Consumers From Accessing Affordable, Life-Saving Drugs Like Insulin

DC Co-Leads Coalition of 23 AGs Claiming FDA’s Orange Book Requirements are Ripe for Abuse by Companies Seeking to Block Competition

WASHINGTON, D.C. – Attorney General Karl A. Racine today led a bipartisan coalition of 23 state and territory attorneys general in a bipartisan letter urging the Food and Drug Administration (FDA) to prohibit use of the FDA Orange Book to block competition. The Orange Book lists patents of drug products and provides an automatic trigger that prevents approval of competing products.

In the comment letter, the Attorneys General express their concern with the affordability of drugs and devices, calling on the FDA to prohibit companies from listing device and component patents in the FDA’s Orange Book. This request is consistent with the recent First Circuit decision in In re Lantus, which addressed component patents, and in the spirit of the Hatch-Waxman Drug Price Competition and Patent Term Restoration Act, which established a balanced framework to benefit drug development and accessibility. The Orange Book enables the branded drug manufacturer to obtain an automatic thirty-month suspension of the FDA’s approval of any potential generic competitor claiming a listed patent. Because of this, Orange Book eligibility requirements for patents are extremely important and are ripe for abuse by drug delivery device patents.

The comments describe insulin delivery devices as an example of how this practice can contribute to oligopoly prices and limited options, and the detrimental impact that has on our society. Despite having been discovered almost a century ago, there are few generic insulin products in part because insulin manufacturers listed drug delivery device patents improperly in the Orange Book. Current research indicates that one in four Americans with diabetes has reported cost-related skimping or skipping on an insulin dose due to a near tripling of costs over the past decade for the four most common insulin formulations.

A copy of the letter is at: https://oag.dc.gov/sites/default/files/2020-09/FDA-Orange-Book-Comment-Letter.pdf

The District of Columbia and Mississippi led the letter and are joined by state and territory Attorneys General of Alaska, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Michigan, Minnesota, Montana, Nevada, New Mexico, Oregon, Puerto Rico, Rhode Island, Virginia, Washington, and Wisconsin.

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