Sen. Tammy Baldwin (D-Wis.) is calling on four major inhaler manufacturers to stop inappropriately listing their patents in the Food and Drug Administration’s (FDA) database. This action could delay the introduction of low-cost generic drugs to the market.
In a letter sent Monday to AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Teva, Mr. Baldwin said that the FDA’s federal database of patents and proprietary information for FDA-approved drugs. Companies were asked to remove inappropriately listed patents from the Orange Book.
When a pharmaceutical company lists a patent in the Orange Book, it blocks the approval of competing drugs for up to 30 months. As a result, pharmaceutical companies have an incentive to list as many relevant patents as possible to protect their exclusivity.
Last year, the Federal Trade Commission (FTC) accused 10 drug companies, including AstraZeneca, GSK, Teva and Boehringer Ingelheim, of improperly or inaccurately listing more than 100 asthma inhaler patents in the Orange Book. I objected.
Baldwin noted that despite the FTC’s warnings, the companies have not yet removed all inaccurate or improperly listed patents from the Orange Book.
“Pharmaceutical companies are required to list certain patents in the Orange Book, but bad actors can abuse this process to inappropriately block competition and the development of generic drugs, reducing treatment options. “This could lead to lower prices and higher prices for consumers,” he said in a statement.
Baldwin’s letter comes after she joined with Sen. Bernie Sanders (R-Vt.) and other Senate Democrats to launch an investigation into the high cost of asthma inhalers made by the same four companies. It has been submitted.
Inhalers sell for hundreds of dollars in the United States, but for a fraction of that abroad.For example, an AstraZeneca inhaler costs $645 in the US but only $49 in the UK
The senators accused manufacturers of abusing the regulatory system, including using the FDA’s database, to ensure their products don’t face generic competition.
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