Washington, D.C. – US. Representative Pramila Jayapal (D-Wash.) and Senator Elizabeth Warren (D-Mass.) sent a letter to Dr. Robert M. Califf, Commissioner of the Food and Drug Administration (FDA), urging him to close loopholes that pharmaceutical companies have exploited to block generics from entering the market, keeping drug prices high and maximizing profits. The letter recommends four specific actions that FDA should take to use its existing authority to address anti-competitive pharmaceutical practices and make prescription drugs more affordable for patients.
Presently, the FDA requires brand-name drug companies to submit patent information that covers drug substances, drug products, and methods of use. After approval, the FDA publishes this patent information in the Orange Book, which contains a complete list of FDA-approved drug and related patent and exclusivity information. Competing drug companies can review this information to determine whether they will seek FDA approval for a generic drug they want to market.
“The pharmaceutical patents in the Orange Book are considered some of the ‘most valuable patents in the world,’ but about 25 percent of active patents in the Orange Book have been invalidated in court,” wrote Representative Jayapal and Senator Warren.
Big Pharma routinely adds improper patents to the Orange Book to block the introduction of lower-cost generics. Because the FDA will automatically delay review of a generic drug for 2.5 years if a brand-name drug company sues that competitor for infringing on an Orange Book-listed patent, Big Pharma companies have an incentive to strategically list “sham” patents in the Orange Book to block generic competition, preserve monopoly profits, and keep prices high.
“The FDA has acknowledged these Orange Book-related problems to Congress and to the public,” wrote the lawmakers. “The agency, with the U.S. Patent and Trademark Office (USPTO), also has announced initiatives to help ensure the patent system ‘is not used to improperly delay getting more affordable generic drugs and biosimilars into the hands of Americans who need them,’ and has sought public comments on the matter. We support these collaborative efforts.”
To ensure competition in the pharmaceutical industry and lower the price of prescription drugs, Senator Warren and Representative Jayapal are recommending that the FDA consider:
- Clarifying guidelines for patents that can be listed in the Orange Book;
- Working closely with the USPTO to develop a review and validation system for every patent that is listed in the Orange Book;
- Revising policies regarding FDA “suitability petitions;” and
- Sharing information provided by drug manufacturers in applications for Investigational New Drugs with USPTO.
The full text of the letter can be found here.