FTC "Ready to Work Closely" With FDA on Abuse of Citizen Petitions

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

Citizen petitions are an avenue for any interested party to ask the FDA commissioner to change agency regulations or take—or refrain from taking—an administrative action. In the case of drug makers, such requests may include asking the FDA not to approve a generic or biosimilar product unless certain conditions are met. The Food and Drug Administration Safety and Innovation Act, enacted in 2012, holds that approval of a pending drug application must not be delayed because of a citizen petition’s request for action (unless the petition convinces the FDA that a delay is needed in order to protect the public health). However, citizen petitions have nonetheless been the subject of controversy, as they require significant time and resources for the FDA to address. Among many stakeholders, there exists a consensus that brand-name drug makers could (and sometimes do) use these petitions to forestall competition from generic or biosimilar drugs.

In its comment letter submitted on the federal docket, the FTC says that it “has a longstanding interest in sham petitioning and other abuses of government processes that may inhibit competition,” and that it supports the FDA’s efforts, through its newly published revised draft guidance on citizen petitions, to deter such inappropriate practices.

The letter also points to prior FTC experience with abusive petitions issued by drug companies. The FTC documents a federal complaint that it lodged against Shire ViroPharma in 2017 for abusing the citizen petition process in order to attempt to maintain a monopoly. According to the letter, Shire filed a series of 43 unsupported citizen petitions to the FDA, and also initiated 3 lawsuits against the FDA over a 6-year period in an attempt to delay generic competition for a particular drug product. Part of Shire’s strategy was to ask the FDA to apply more stringent testing to a proposed generic drug than was required for its innovator product. Even after a panel of experts rejected Shire’s arguments, said the FTC, the drug maker continued to make petitions, effectively delaying competition and costing consumers hundreds of millions of dollars.

Given such abuses of the citizen petition process, said the FTC, the agency stands “ready to work closely” with the FDA on citizen petition abuse and other issues that may harm competition.” While the FDA has taken meaningful action in the past to combat drug makers’ abuse of government processes, “this behavior continues to delay generic entry and burden FDA staff. We commend the FDA’s renewed efforts to curb abuse of the citizen petition process and to promote competition.”