Warren, Jayapal Call on FDA to Clear Patent Hurdles for Generic Drugs

Anna Edney
·2 min read
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(Bloomberg) -- Senator Elizabeth Warren and Representative Pramila Jayapal called on the top US drug regulator to close loopholes that delay competition to established drugs that enable big companies to keep high prices in place longer.

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Democrats Warren, of Massachusetts, and Jayapal, of Washington, wrote Food and Drug Administration Commissioner Robert Califf on Monday urging the agency to do more to stop brand-name drugmakers from keeping lower-cost generic drugs off the market. In their letter, the lawmakers called for changes to rules that “pharmaceutical companies have exploited to rake in billions in profits.”

Brand-name drugmakers have been accused of blocking generic competition by methods such as delaying the filing of patents to extend their protection. President Joe Biden’s signature legislation, the Inflation Reduction Act, tries to address pharmaceutical affordability by making prices for drugs that have been on the market for years without generic equivalents eligible for negotiation through Medicare, the health program for the elderly.

One tactic for keeping generics off the market involves a publication called the Orange Book, which lists every FDA-approved drug as well as many patents filed in relation to each drug, the lawmakers wrote.

The Orange Book, which is public, can be used by generic-drug companies to determine when they might file for approval of their copycat versions of brand-name drugs. Approval is often sought before all the corresponding patents have expired. But if a generic maker is sued by the maker of name-brand drugs based on any patents listed in the Orange Book, there’s automatically a 30-month stay on the FDA’s ability to approve the generic version.

The FDA should be more strict about the patents it lets drugmakers list in the Orange Book, given it currently does minimal oversight, the lawmakers wrote.

The FDA should share more information on drug development with the US Patent and Trademark Office so that agency can determine if pharmaceutical companies are using patents anti-competitively, according to Warren and Jayapal. The legislators offered recommendations for steps the FDA could take to lower pharmaceutical costs for consumers and requested a briefing by Sept. 13.

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