FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

Posted 18 November 2014 By Alexander Gaffney, RAC


A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking.


FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of Congress or the President of the United States. In other cases, it identifies a public health need and, after consulting with various stakeholders, takes action.

FDA also maintains another pathway for action aimed at allowing companies, groups and members of the public to "petition" it to take action based on the merits of an argument or law.

There are two distinct types of petitions: Citizen Petitions (21 CFR 10.30), and Petitions for Stay of Agency Action (21 CFR 10.35). The former implores FDA to take an action. For example, FDA is often asked to approve or disapprove a drug product application, to add warnings to a product, to make a product more easily available or to change the application of a regulatory policy.

In contrast, Petitions for Stay of Agency Action call for FDA to refrain from taking an action. For example, a company might petition FDA to not approve a product until the agency has reviewed new data, or because a product infringes on existing patents.

Both types of petitions are used frequently, and FDA is generally required to respond to a petition within 150 days of its submission, though it frequently takes longer.

Petitions and Delays

But there's a dark side to the petitions, a side acknowledged by legislators when they passed the Food and Drug Administration Amendments Act (FDAAA) in 2007: Petitions can be used to unnecessarily delay the entry of new drugs.

Prior to the passage of FDAAA, petitions were frequently used by branded drug companies to delay generic competitors. While petitions can, and do, frequently raise important matters regarding their generic competition, legislators were concerned that their overuse was harming consumers by delaying the entry of lower-cost generics.

To make it easier for FDA to dispose of supposedly frivolous citizen petitions, FDAAA Section 505(q) of the Federal Food, Drug and Cosmetic Act (FD&C Act). Section 505(q)(1)(E) of the law specifically permits FDA to reject any application whose clear intent is to "delay" the entry of a competitor.

"If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application and the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination," the law states.

To date, FDA has never rejected a petition on these grounds.

Annual Reports

In addition to giving FDA new powers to reject supposedly frivolous petitions, FDAAA (Section 914) also requires FDA to report on how many petitions it considers intended to delay an applicant on an annual basis.

On an annual basis, FDA is supposed to report on the number of drug applications [under Section 505(j) or 505(b)(2) of the FD&C Act] approved during the prior 12-month period, the number of drug applications that were delayed due to petitions, how long the drugs were delayed by, and how many petitions were submitted to FDA.

A New Report

FDA is now out with its sixth report since the passage of FDAAA, and agency records show that petitions meant to delay approval of other drugs—505(q) petitions—appear to be at an all-time low.

 505(q) Petitions Received by FDA

In plain terms, FDA received 92 petitions in 2013. Of those, 15 petitioned for FDA to delay the approval of a pending 505(j) application for a generic drug or 505(b)(2) application for a highly similar drug product.

That data only tells part of the story, however. Not all 505(q) petitions are necessarily frivolous—they're just petitions with the potential to be frivolous. For example, FDA's report recalls at least seven instances in which it determined that a delay in the approval of an abbreviated new drug application (i.e. generic drug application) was "necessary to protect the public health." These petitions resulted in a delay for the drug being approved, FDA said.

FDA Petition Rejections High

FDA's report indicates it rejects the overwhelming majority of the 505(q) petitions it receives.

Outcomes of 505(q) Petitions Resolved During FY 2008-2013     
Fiscal YearPetition DeniedPetition GrantedPetition Granted/Denied in PartPetition WithdrawnTotal
200810 (71%)13014
200916 (66%)26024
201016 (66%)26024
201110 (45%)19222
201210 (76%)12013
201321 (77%)15027
Total83 (67%)8312124

FDA denied 83, or 67%, of the 124 applications it received between 2008 and 2013. It approved just 8, or 6%, of applications outright, and partially approved 25% of applications.

Notably, FDA is now denying petitions at its highest rate ever. FDA's rejection of 21 505(q) petitions is its highest ever recorded, both by number and as a percentage of petitions received.

Not all petitions were resolved during the fiscal year in which they were submitted, FDA noted, accounting for discrepancies between the total petitions resolved in a given year and the number submitted.

FDA: 505(q) Authority Failing

FDA's report contains other interesting data and conclusions as well.

As noted earlier in the report, FDA has never rejected a petition using 505(q)'s authority which allows it to reject petitions whose sole intent is to delay the entry of a drug. The agency has said this authority, while well-meaning, is in practice too difficult to use and would take "substantial amounts of resources" to prove.

FDA said it remains "concerned that section 505(q) is not discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and that do not raise valid scientific issues." Some companies are even "implementing strategies to file serial 505(q) petitions and petitions for reconsideration in an effort to delay approval of ANDAs or 505(b)(2) applications for competing drugs," FDA said.

While these efforts have successfully delayed some ANDAs, they have—to date—never successfully delayed a biosimilar (351(k) application) or 505(b)(2) application.

For example, to date, no biosimilar products or 505(b)(2) applications have been delayed based on 505(q) petitions, FDA said.

Other Notable Data

Also noteworthy in the report is FDA's data on the ebb and flow of applications approved by FDA during each fiscal year. After two years of straight growth in ANDA approvals, for example, FY 2013 saw a marked dip in the number of generic drugs approved—77 fewer than the year before. That could be the result of a slowdown in the number of expiring patented medicines, however.

Applications Approved by FDA  
Fiscal YearANDA505(b)(2)

505(b)(2) approvals, meanwhile, have remained fairly consistent.


Sixth Annual Report on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal year 2013

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Categories: Generic drugs, Regulatory strategy, Submission and registration, News, US, CDER

Tags: ANDA, Abbreviated New Drug Application, 505(b)(2) Application, 505(q) Petition, Citizen Petition

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