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After years of concern, the Food and Drug Administration issued a rule on Tuesday that limits the use of citizen petitions to delay approval of generic drugs or biosimilars. The move comes after repeated complaints by agency officials that many petitions generally do not raise valid scientific concerns and appear to have been filed solely to delay rival medicines.

The rule, which goes into effect this coming January, comes after the FDA issued new guidelines five years ago that were intended to limit such petitions. Congress, however, requires the FDA to respond to most petitions within 150 days, but agency officials have complained this creates an unnecessary problem.

As the FDA explained in an annual report to Congress that was filed last August, federal law requires the agency to review petitions on a timely basis in the event that a public health concern is legitimately raised. Yet the agency is not supposed to delay approval unless the petition has raised a public health issue. This puts the FDA in a tough spot.


As we noted at the time, FDA officials believe it is “difficult to determine” whether existing law is sufficiently discouraging petitions that are “aimed at blocking generic or biosimilar competition.” They expressed concern that most petitions are a competitive ruse that forces the agency to redirect efforts at the expense of completing other work.

“When submitted early, such as when we are making decisions about the bioequivalence requirements for a generic drug product or before we have received the first [application] for a drug or biologic, a petition may contain information that can contribute towards our evaluation of an application,” the FDA wrote in its rule.


“However, when petitions are submitted late in the review process for challenged applications and do not raise valid scientific or legal issues, they may have the effect of improperly delaying the approval of an application.” In its report to Congress, the FDA provided data showing 114 or 167 citizen’s petitions — or 68 percent — between 2008 and 2015 were denied.

“The whole intention of the law is to limit the ability of pharma to throw up frivolous barriers to slow down generic or biosimilar approvals,” said James Shehan, senior counsel at the Lowenstein Sandler law firm and former general counsel at Novo Nordisk. “The final rule seems fairly faithful to the law. And I think it narrows the field a little, but I don’t think it eliminates” every potential frivolous petition.

He noted that the pharmaceutical industry trade group sought to convince the FDA to notify drug makers when a petition would be denied. Shehan explained that the industry wants the chance to try to use court proceedings, such as a temporary restraining order, to then block a drug approval. The reason is that the FDA often denies a petition and issues a generic drug approval at the same time.

“By then, it’s kind of a done deal,” Shehan said. “Good luck to a company trying to stop a launch after it’s already started.”

This type of scenario was criticized in a paper published earlier this week by attorneys at Hyman, Phelps & McNamara, which specializes in regulatory issues. The lawyers chastised the FDA for a “broken” approval system. They cited an instance last spring when AstraZeneca filed a petition to thwart generic versions of its Crestor cholesterol pill and, days later, filed a lawsuit against the FDA to push the agency to review its petition.

Meanwhile, a recent analysis co-authored by Michael Carrier, a Rutgers University law professor, found brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015, although the FDA denied more than 9 out of every 10 petitions. Yet another analysis, which Carrier also co-authored, cited as an example of abuse a petition filed last year by Mylan Pharmaceuticals to thwart a rival to its EpiPen device.

  • Being an FDA lawyer is like being in a circular firing squad. Remember the Crestor Astra Zeneca Citizen’s Petition? It was accompanied by a lawsuit to thwart generics. Without the ability to submit the CP the drug companies will turn to lawsuits as their sole delaying tactic, and there is NO guarantee that future suits will be resolved as quickly as the AZ suit was. That’s why drug company lawyers make $400/hour and FDA lawyers don’t.

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