Regulatory Focus™ > News Articles > FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals

FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals

Posted 08 November 2016 | By Zachary Brennan 

FDA Declines PhRMA Changes, Offers Final Rule on Citizen Petitions Delaying Generic Approvals

The US Food and Drug Administration (FDA) on Tuesday announced a final rule amending regulations on citizen petitions that would ensure the agency does not delay the approval of a pending generic drug or biosimilar because of such petitions, unless that delay is necessary to protect the public health.

The final rule, which is effective 9 January 2017, implements section 505(q) of the Federal Food, Drug & Cosmetics Act (FD&C Act), which governs the manner in which FDA handles certain citizen petitions and PSAs that ask the agency to take action related to an abbreviated new drug application (ANDA), a 505(b)(2) application, or an application submitted under section 351(k) (ie. A biosimilar application).


For years, FDA has received numerous petitions requesting the agency not approve a particular ANDA or 505(b)(2) application unless certain criteria are met. But as FDA notes, in many cases, the petitions have raised scientific and/or legal issues relating to the standards for approval of an application (ie. suggesting a particular method for demonstrating the bioequivalence of a proposed generic to the reference listed drug (RLD) and petitions maintaining that a proposed generic product does not contain the same active ingredient as the RLD). 

“However, when petitions are submitted late in the review process for challenged applications and do not raise valid scientific and/or legal issues, they may have the effect of improperly delaying the approval of an application,” the rule notes.

And by implementing this rule, FDA is essentially putting into action Congress’ desire to ensure that petitions are not used to improperly delay approval of generics or biosimilars.

PhRMA Comments

The pharmaceutical industry lobbying group, known as Pharmaceutical Research and Manufacturers of America (PhRMA), offered several comments and requested changes on the proposed rule but FDA rejected and responded to nearly all of them.

For instance, PhRMA requested that FDA include or otherwise establish a mechanism for notifying a petitioner if the agency determines that a delay of approval of an ANDA or 505(b)(2) application is not necessary to protect the public health, but FDA declined to implement such a mechanism as it was not included in the section of the legislation being implemented.

PhRMA also requested that FDA issue a regulation establishing (or clarifying) that a delay in an ANDA or 505(b)(2) application approval can extend beyond the 150-day review period for a petition.

But FDA said: “We decline to issue a regulation establishing or clarifying that a delay in approval of an ANDA or a 505(b)(2) application can exceed the 150-day review period for petitions. Because of the uncertainty in predicting the time it will take to resolve a particular issue, establishing an expectation on the possible length of a delay would be neither practical nor feasible.” 

Cost to Industry

FDA said it estimates one-time costs to industry from this rule at about $613,800, while annual costs will likely be about $1,700.

Final Rule: Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets



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