BioPharma, Legal

FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

AbbVie, AstraZeneca, and GSK are among the 10 companies now under scrutiny by the Federal Trade Commission, which is cracking down on businesses it says improperly or inaccurately placed items on a list of FDA-approved products as a way to hold off generic competition.

The commission on Tuesday said it is challenging more than 100 patents in this “Orange Book,” disputing the accuracy or relevance of the listed patent information. The challenge means that product manufacturers might have to remove their listings.

The Approved Drug Products with Therapeutic Equivalence Evaluations is the published list of FDA-approved drugs deemed both safe and effective. It is more commonly called the Orange Book, a reference to the color of the cover of the printed document. This publication may be viewed by anyone, and clinicians can use it to search for generic equivalents to brand name drugs. But an Orange Book listing can also serve as a way keep a generic competitor from reaching the market for a little while longer.

When a generic drugmaker files an application seeking product approval before a branded product’s patents have expired, the manufacturer of the branded product can sue for patent infringement. Filing suit grants a 30-month stay of a regulatory approval of the generic product. This stay is intended to give both parties time to resolve the litigation, but the FTC notes that this provision can also be used to delay lower-cost generic alternatives from reaching the market. If a patent’s listings in the Orange Book is improper as defined by the law, that listing may negatively affect competitive conditions, the agency said.

The patents challenged by the FTC cover products such as inhalable asthma treatments from AstraZeneca and Boehringer Ingelheim; epinephrine autoinjectors from Mylan; and the AbbVie dry eye drug Restasis. The other companies who received FTC notice letters are Impax Laboratories, Kaleo, and subsidiaries of GSK and Teva Pharmaceutical. The FTC warned the biopharma industry in September that it would be taking a closer look at the Orange Book for improper patent listings.

“Brand drug manufacturers are responsible for ensuring their patents are properly listed,” the agency said in its six-page policy statement. “Yet certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. When brand drug manufacturers abuse the regulatory processes set up by Congress to promote generic drug competition, the result may be to increase the cost of and reduce access to prescription drugs.”

Improper Orange Book listings may have distorted the pharma market for decades, the policy statement said. An FTC review of the potential effects of improper Orange Book listings was included in a 2002 study that “identified numerous instances in which the 30-month stay was used to block competition.”

Under FDA regulations, any interested individual may dispute the accuracy or relevance of patent information in the Orange Book. The FTC is challenging patents within the FDA’s dispute framework, under which the FDA will notify the drugmakers. That notice gives companies 30 days to withdraw or amend their listings, or alternatively certify that the listings comply with all applicable laws and regulations. But the FTC added that its own letters of notice to the 10 companies indicate that the antitrust regulator retains the right to take further action in the public’s interest, including investigation of their conduct as a violation of federal laws.

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