Sen. Tammy Baldwin (D-Wis.) is demanding the four largest manufacturers of inhalers stop improperly listing patents in a Food and Drug Administration (FDA) database, a practice that can delay lower-cost generics from coming to market.
In letters sent Monday to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Teva, Baldwin called on the companies to remove their improperly listed patents from the FDA’s Orange Book, the federal database where patent and exclusivity information for FDA-approved drugs is listed.
When a pharmaceutical company lists a patent in the Orange Book, it blocks the approval of competing drug products for up to 30 months. As a result, drug companies have an incentive to list as many associated patents as possible in an attempt to protect their exclusivity.
Last year, the Federal Trade Commission (FTC) challenged 10 pharmaceutical companies, including the four listed in Baldwin’s letter, for improperly or inaccurately listing more than 100 asthma inhaler patents in the Orange Book.
Baldwin noted that the companies have not yet removed all the inaccurate or inappropriately listed patents from the Orange Book, despite the FTC warning.
“While drug companies are required to list certain patents in the Orange Book, bad actors can exploit this process to inappropriately deter competition and generic drug development, leading to fewer treatment options and higher prices for consumers,” she said in a statement.
Baldwin’s letter comes after she joined Sen. Bernie Sanders (I-Vt.) and other Senate Democrats to launch an investigation into the high costs of the asthma inhalers made by the same four companies.
The inhalers sell for hundreds of dollars in the U.S. but for only fractions of that same cost overseas. For example, one of AstraZeneca’s inhalers costs $645 in the U.S. but just $49 in the U.K.
The senators accused the manufacturers of exploiting the regulatory system to ensure their products don’t face competition from generics, including use of the FDA’s database.