Issues

Citizen Petitions

GPhA Position

In the FDA Revitalization Act of 2007, Congress passed a measure that would curb the abuse of citizen petitions by brand companies. Under the law, FDA is required to move forward with the generic approval process while a petition is being considered. In addition, final action on a petition must be taken within six months of its receipt. Now, Congress needs to provide FDA with the resources to ensure implementation of this law, which will increase consumer access.

Key Points

keypoint-paper_1.jpg

The FDA typically will not review an abbreviated new drug application (ANDA) for a generic product until all underlying issues in a citizen petition have been addressed. If this only happened once in a while, it might not be so problematic. However, some brand companies routinely file citizen petitions on the eve of a generic's approval, sabotaging the marketing of a cost-saving generic for months, if not years.

keypoint-law_1.jpg

According to a Merrill Lynch review of citizen petitions filed between 2000 and 2005, more than three-quarters of them were dismissed as having no merit. It's clear that these petitions are being filed not to raise legitimate issues, but to block consumer access to affordable generic medicines.

keypoint-capitol_1.jpg

In 2007, Congress passed legislation that would help curb the abuse of citizen petitions by brand companies.

Background

The citizen petition process allows citizens to raise, for the FDA's consideration, legitimate issues relating to products the agency regulates. Unfortunately, the citizen petition process has been abused by some brand pharmaceutical companies as a tactic to extend their brand product monopolies by delaying generic competition.

To help curb this abuse, Congress passed the FDA Revitalization Act in 2007. The Act mandated that FDA move forward with the generic approval process while a petition is being considered. In addition, it required that final action on a petition be taken within six months of its receipt.

In 2008, a bipartisan group of members from both the U.S. House and Senate expressed concern that the FDA was not moving aggressively enough to implement the new law. GPhA is continuing to work with Congress and the FDA to ensure that the Agency has the requisite resources it needs to ensure that improved citizen petition process is followed.

Related Information

Letters

December 15, 2005 - GPhA letter to FDA regarding citizen petition reforms (199.47KB PDF)