How Drug Companies use Loopholes to Delay Generic Drug Approvals


The citizens petition process is being used to delay approval of generic drugs.

In the 1970s the FDA introduced a citizen-petition process into its generic approvals to make them safer. But new research has shown that this process is being used by drug companies to delay approval of generic drugs.

A study, published March 1 in The New England Journal of Medicine, and forthcoming in the Stanford Technology Law Review, analyzed all citizen petitions filed between 2000 and 2012. It found “widespread, strategic use of the citizen-petition pathway by drug companies striving to hold off competition.”

The petitions request more investigation or data about a drug, and can either delay the approval of a generic version of a branded drug or prevent it entirely. Nearly half of the petitions studied were filed within the year and a half before the FDA approval of a generic. A large number, 40%, were filed less than a year before the approval. The number of these delay-related petitions has more than doubled since 2003.

Although it is possible that these late petitions were filed because of information found late in a drug’s approval process, the FDA has said that most of them “contained data that had been available to the petitioner well before the date of the petition.” The study authors concluded that drug companies are using these petitions as a delaying tactic.

The authors note that many petitions raised real concerns. They cited a 2003 case in which Wyeth Pharmaceuticals argued that a lack of labeling in generic versions of its immunosuppressant Rapamune (sirolimus) created safety concerns. The FDA agreed on this point.

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But the authors found that these legitimate cases “appear to be the exception rather than the rule.” For example, Mutual Pharmaceuticals drafted a petition to delay generic versions of its antihypertensive Plendil (felodipine). The concern was whether drinking juice from Seville oranges, which are bitter and rarely used for juice, affected absorption. The FDA denied the petition, citing a lack of evidence from Mutual.

In another example, on the day before a generic version of its antibiotic Doryx (doxycycline) was to be approved, Warner Chilcott started marketing the tablets with two score lines instead of one, and asked that all generic versions of the drug do the same. The FDA said it could find no safety concerns regarding a single-score tablet, denied the petition immediately, and approved the generic.

Up next: The future of citizen petitions


The FDA reportedly rejects about 80% of citizen petitions filed by competitors. However, the other 20% can delay the approval of generics. The authors cite evidence of many petitions asking the FDA to delay approval until the generic manufacturer performs tests it already completed in the approval process. The FDA is forced to honor the request despite the redundancies.

In 2007, Congress amended the FDA Act with the hope of blocking potential abuses of the system. Some of these changes included requiring the FDA to respond more quickly to citizen petitions-now within 150 days-and allowing the FDA to dismiss petitions designed to delay generic approvals or those that “raise no valid scientific or regulatory issues.”

However, the ruling seems to have had little effect. The number of petitions has increased, and as of fiscal year 2014, the FDA had not denied a petition under the provision. “The Agency,” the FDA said in a 2015 report, “continues to be concerned that section 505(q) is not discouraging submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues.” Additionally, in the same report, the FDA also expressed concern that the resources required to respond to petitions within 150 days came “at the expense of completing the other work of the Agency.”

In 2016, the FDA enacted more rules designed to reduce delays, but even these new rules could have the same lack of enforcement.

So what should be done? The study suggests that the most effective means of preventing these abuses would be to enact stronger procedural blocks. One suggested block would be to require drug companies to file a petition within a year of a generic drug company filing an application.

Robin Feldman, Harry & Lillian Hastings Professor of Law at University of California Hastings College of the  Law, San Francisco, and lead author of the study, believes that stopping these practices will take cooperation from all sides. In an interview with Drug Topics, Feldman stressed the importance of pharmacist involvement. “Pharmacists are always on the front lines,” she said. “They see the pain for individual customers who cannot afford the skyrocketing prices of their medications. Pharmacists are also critical partners in exposing strategic pricing behaviors. They have an inside view of how pricing behaviors and strategies discourage generic substitution.”

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The report stressed the need for transparency within the FDA. Finding basic information, such as the application filing dates from generic drug companies, required poring through “volumes of letters and approval documents,” and even then the information might not be available.

“Perhaps the greatest transparency mechanism would be to make real pricing information public,” Feldman said. “What do specific drugs really cost? What coupons or rebates are distributed? Such information would allow regulators, legislators, and the public to uncover troubling behaviors.”

Pharmacists are, according to Feldman, “in the position to point out game-playing when they see it. They can also be honest brokers in the discussion, explaining what they witness for desperate patients.”

“Without increased transparency,” the NEJM study stated “society cannot curb strategic behaviors such as citizen-petition abuse.”

“And as always, the public pays the cost.”

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