How Citizen Petitions Are Abused to Delay Generic Drug Access

The citizen petition process is provided by the Food and Drug Administration (FDA) to raise legitimate safety concerns about prescription drugs. At its best, it is an outlet for ordinary people to make their voices heard and to point out problems with proposed medicines. But the process is currently being grossly abused. Yesterday, at a Federal Trade Commission workshop on competition and prescription drug markets, Professor Michael Carrier pointed out the manipulation of this process by brand-name companies and suggested a few possible solutions.

Professor Carrier conducted an empirical study of all citizen petitions between 2011 and 2015 filed against generic drugs that were pending approval. He found that the FDA denied 92% of the petitions, and that it denied 98% of late-filed petitions (which are filed within six months of the expiration of a patent or FDA exclusivity). There are even more egregious examples; the company Bayer filed a petition on IUD Mirena the day before the drug's patent expired.

And Allergan, which recently transferred its patents for the eye drug Restasis to the Saint Regis Mohawk Tribe in an attempt to avoid competition, has filed multiple petitions in an attempt to delay generic drugs from coming to market. One petition was filed in February 2014 and denied in November 2014, another was filed in December 2014 and denied in February 2016, and a third was filed in August 2017. Recently a judge invalidated six Restasis patents, but the generics Mylan, Teva, and Akorn still can't enter the market because of the August 2017 petition. This is not in the spirit of the process, and not what citizen petitions are supposed to be used for.

Brand-name drug companies are twisting the citizen petition process for their ends. Instead of a way to safeguard consumers from problematic drugs, they are using it to delay generic drug access so they can continue to charge outrageous prices. And consumers are paying the price--literally. We have previously written on these problems, which are widely recognized. Congress amended the law in 2007 to make abuses harder, and the FDA has to make a decision on petitions within 150 days of its submission in order to avoid unnecessary delays.

Possible solutions? We recommended conducting a study on the continued usefulness of citizen petitions, possibly scaling back the program or instituting requirements, and requiring public disclosure of the real parties involving in filing petitions. We hope that these reforms will be adopted soon; there have already been too many delays.