Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why Citizen Petitions to the FDA are so controversial among generic and biosimilar stakeholders.
Why are Citizen Petitions to the FDA so controversial?
I think they’re controversial because people don’t understand exactly what they do and what they’re used for. Petitions, as the name implies, can be filed by anybody. They can be filed by citizens, they’re often filed by public interest organizations, but pharmaceutical companies also submit them and I think the concern is that they will submit them primarily to delay generic competition.
That might have been true in the past, but the law was changed back in 2007 to prevent that. The law currently says that the FDA review of a petition goes along one level and the review of the application, or the abbreviated new drug application (ANDA), goes along another. A petition cannot delay an approval of a generic application unless there’s a public health issue. The FDA actually puts out data every year about how many petitions are filed, how many will delay applications, and if you look at FDA’s own data, less than 1% of generic applications are delayed because of a petition.
The problem is really more of perception, and I think the issue is that there’s a lot of bad information out there. There have been a number of press reports, and actually academic publications, which purport to analyze petitions and have come up with the claim that they actually do delay generic competition. But, all of these publications, when they do their analyses, they rely on a lot of assumptions and they actually ignore FDA’s own data. I personally file a lot of petitions myself, so maybe I’m a little bit biased, but I’ve never had a petition that delayed a generic application. They raise issues, a lot of times the companies that submit them have the most information about the product, so they raise these issues with FDA, FDA considers them, but I think in very, very few cases, and only when public health is potentially involved, will it actually delay FDA’s decision on an application.