Senators Call for Inhaler Manufacturers to Remove Incorrect Patents from FDA Database

In a recent development, four major inhaler manufacturers have been called upon to remove inaccurate patents from the Food and Drug Administration (FDA) database. Senator Tammy Baldwin (D-Wis.) has demanded that AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK), and Teva rectify the practice of including incorrect patents in the FDA’s database. This practice has the potential to delay the entry of cheaper generic alternatives into the market.

The FDA maintains a database that contains information about patents and exclusivity rights for drugs approved by the agency. When a pharmaceutical company includes a patent in the Orange Book (FDA’s database), it can block the approval of competing medicinal products for up to 30 months. Consequently, pharmaceutical companies have the incentive to include as many related patents as possible to protect their exclusivity.

Last year, the Federal Trade Commission (FTC) questioned ten pharmaceutical companies, including AstraZeneca, GSK, Teva, and Boehringer Ingelheim, for improperly or inaccurately including over 100 patents for asthma inhalers in the Orange Book.

Senator Baldwin has noted that these companies have yet to remove all the incorrect patents from the Orange Book, despite FTC warnings. This practice restricts competition and inhibits the development of generic medications, resulting in limited treatment options and higher prices for consumers.

This call from Senator Baldwin comes after joining Senator Bernie Sanders (I-Vt.) and other Democratic senators in initiating an investigation into the high costs of inhalers for asthma patients produced by these same four companies.

Inhalers are sold in the US for hundreds of dollars, while they cost only a fraction of that price abroad. For instance, an AstraZeneca inhaler costs $645 in the US, but only £49 in the UK. The senators have accused manufacturers of exploiting the regulatory system through the use of the FDA database to ensure their products face no competition from generics.

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The source of the article is from the blog girabetim.com.br