UPDATED: FDA's new citizen petition rules remove speed bumps for generic, biosim approvals

FDA sign

Branded drugmakers may have one less tool to delay generic competitors--and, crucially, biosimilar versions of some of the industry's top-selling products--with Tuesday’s decision by the FDA to amend citizen petition rules.

Moving forward, the agency won’t delay a generic or biosimilar approval solely because a drugmaker files a citizen petition, Regulatory Focus reports. It’s a tactic that some companies have used as a last-ditch effort to protect sales for aging but important products

Effective January 9, FDA’s new rules would implement the Food, Drug and Cosmetics Act's citizen petition rules differently than the agency's current regulations do. The idea is to ensure that a generic or biosim isn’t delayed by petitions that “do not raise valid scientific and/or legal issues.” In issuing the change, the agency rejected multiple requests by industry lobby group PhRMA, according to Regulatory Focus.

James Shehan, senior counsel at Lowenstein Sandler, said the move will likely eliminate some “frivolous” challenges by pharma companies against new generics. “But at the same time, if you do have legitimate scientific issues that go to safety and efficacy of the products, then you can use the citizen petition process to impact” the approval process, he said. 

Among other things, PhRMA requested to receive notifications about denied petitions and clarification on approval delays, according to the Federal Register.

A PhRMA spokesperson said the group is reviewing the rule changes and has no comment as of Wednesday morning.

In one high-profile citizen petition case this year, AstraZeneca filed an eleventh-hour request that the agency block Crestor generics on claims that a new orphan drug approval should allow the med 7 additional years of patent protection. The pharma separately then sued and asked a court to stop generic entrants.

Two weeks later, a judge in the case said that FDA’s ruling on the petition would be announced at a closed-door meeting with stakeholders and sealed until the court can issue its own ruling.

FDA’s generic approval methods, particularly its handling of citizen petitions, have generated negative attention in the past, with FDA Law Blog attorneys writing this week that the system is “broken” and “must be fixed."

Editor's note: This story was updated with comments from Lowenstein Sandler senior counsel James Shehan.