James Shehan, JD: The FDA and Citizen Petitions

James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP, discusses how the FDA plans to address citizen petitions that impede market entry of competitive products.


How does the FDA plan to crack down on citizen petitions that are used to delay market entry of competitor products?

When we talk about the use of citizen petitions to impede or potentially affect the entry of competitive products in the marketplace, we’re talking about a narrower class of citizen petitions for which Congress actually enacted a separate provision of the statute, 505q. What that essentially says is there’s a citizen petition that is potentially going to delay a generic product, either an [Abbreviated New Drug Application, ANDA], a 505(b)(2), or 351k biosimilar, that FDA has to make decisions on those in an expedited fashion.

The FDA recently issued some guidance about changing the way that it views and reviews citizen petitions that come in to delay the entry of a generic drug into the market. What’s essentially said is given a lot more detail on how it will view those types of petitions and it has issued a set of criteria that it will look at in deciding whether one of these petitions has a primary purpose of trying to delay generic competition.

The agency has also said, if it makes that determination, that it’s going to refer the matter to the Federal Trade Commission for possible investigation of anticompetitive activities. Which FDA has done on at least 1 occasion regarding Shire and its vancomycin product where there were a number of citizen petitions submitted over a period of years.

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