Michigan Attorney General Dana Nessel has joined a bipartisan coalition of 23 attorneys general in signing a letter urging the Food and Drug Administration (FDA) to prohibit use of the publication “Approved Drug Products with Therapeutic Equivalence Evaluation” – commonly known as the Orange Book – to block competition. In a letter sent Tuesday, the attorneys general argue that by permitting the entry of drug delivery devices into the Orange Book, the FDA would be allowing drug companies to keep the price of insulin inflated.
The Orange Book enables branded drug manufacturers to obtain an automatic 30-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 manufacturers.
The comment letter describes insulin delivery devices as an example of how this practice can contribute to higher 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.
“Michiganders are among the millions of people across this country who depend on their insulin doses to make it through each day and they shouldn’t have to ration those doses simply because of a technicality that impedes their access to affordable medicine,” said Nessel. “My colleagues and I are urging the FDA to take action to ensure their processes don’t stand in the way of more affordable drugs.”
In the letter — a response to a call for public comment by the FDA — the attorneys general express their concern with the affordability of drugs and devices and call 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.
Nessel joins the attorneys general of Alaska, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, Minnesota, Mississippi, Montana, Nevada, New Mexico, Oregon, Puerto Rico, Rhode Island, Virginia, Washington, and Wisconsin in submitting the comment letter.
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