Citizen petitions can curb generic drug competition, costing billions

When it comes to cereal, more people probably prefer brand-name boxes over their generic cousins. But when it comes to the medicine cabinet, generic drugs save consumers a lot of cash.

Generic drugs are functionally the same as brand-name drugs, but they’re cheaper to make and therefore cost consumers less. Per the FDA, generics drive overall drug costs down, making medicines more accessible to people who need them, and easier for payers to cover.

But, there are several factors that make it hard for generic drugs to get approval, and one in particular plays a big role in delaying generics from hitting the market, according to researchers from the Brookings Schaeffer Initiative on Health Policy (Brookings Schaeffer Initiative). That factor is citizen petitions.

A lack of generic competition, due to the delays caused by citizen petitions, has major economic consequences. A 2020 study from the University of California San Francisco estimated that the “cost to society” of what the researchers described as four “baseless” citizen petitions delaying generic competition totaled $1.9 billion, with $782 million falling on government payers during two one-year periods (2008 and 2012).

What’s a citizen petition?

Whenever a drugmaker files an application with the FDA seeking approval for a new drug, anyone can file a citizen petition and ask the FDA to delay or reject that application.

Consumer advocacy groups may file a citizen petition for a drug if they’re concerned about potential side effects, which the group Public Citizen did in 2019 when it filed a petition against the osteoporosis drug Prolia (made by Amgen) over concerns that the drug caused an increased risk of vertebral fractures.

But citizen petitions have been “misused, to a large extent, to delay competition,” Richard Frank, senior fellow and director of the Brookings Schaeffer Initiative, told Healthcare Brew.

Most citizen petitions are filed by brand-name drugmakers, according to research from the Brookings Schaeffer Initiative. Those drugmakers often file petitions close to the date when they are to lose patent exclusivity on a drug.

The FDA overwhelmingly denies the petitions, but even so, a pending petition can delay the approval process because the FDA has 150-180 days to respond.

During those delays, brand-name drugmakers can rake in cash since they face no competition. One study found that citizen petitions successfully delayed generic alternatives for the insomnia drug Ambien for 1,225 days, and during that time, brand-name drugmaker Sanofi made $3.1 billion in sales.

“That is a boatload of money that taxpayers and consumers are shelling out that they don’t have to,” Frank said.

A remedy to the problem

In an attempt to make it harder for brand-name drugmakers to delay generic competition via citizen petitions, Frank and his colleagues at the Brookings Schaeffer Initiative made several suggestions in a 2022 white paper.

First, the FDA should be required to move a lot more quickly when making a decision to grant or deny a citizen petition, Frank said. And it should be easier for the FDA to quickly dismiss a petition that has no merit, he added.

Frank and his colleagues also suggested the FDA be allowed to impose fines on brand-name drugmakers who file citizen petitions with the intent to delay competition.

“Don’t throw out the opportunity for legitimate folks to do it, but don’t create this big incentive for filing by a brand-name company,” Frank said. “By allowing the FDA to dispose of these more quickly […] you dramatically reduce the incentive to file these delaying tactics.”