File this under ‘Some things just don’t change.’
Once again, the US Food and Drug Administration filed an annual report to Congress about citizen’s petitions that can be used to ask the agency to refrain from approving a generic drug or a biosimilar. And once again, FDA officials reiterated complaints that many petitions generally do not raise valid scientific concerns and appear to have been filed to delay approval of competing medicines.
This is actually a long-standing issue for agency officials, despite having released new guidelines five years ago that were intended to limit such petitions. Congress, however, requires the FDA to respond to most petitions within 150 days. And as far as the FDA is concerned, this creates an unnecessary problem.
Why? Well, federal law requires the agency to review the petitions on a timely basis in the event that a public health concern is legitimately raised. At the same time, the FDA is not supposed to delay approval unless the agency decides that the petition has, indeed, raised a public health issue. This puts the FDA in a bind.
And FDA officials wrote that it is “difficult to determine” whether existing law is discouraging petitions that are “aimed at blocking generic or biosimilar competition.” In fact, agency officials are concerned that most petitions are merely a competitive ruse, and they wrote Congress that they are forced to redirect efforts “at the expense of completing the other work of the agency,” according to the recently released report.
In effect, the report suggests that the petition process continues to be manipulated, if not abused, especially after Congress reduced the FDA review time to 150 days from 180 days with the passage of the FDA Safety and Innovation Act in 2012.
The concerns expressed by FDA officials largely mirror a forthcoming analysis, which was coauthored by Michael Carrier, a Rutgers University School of Law professor who specializes in intellectual property. The analysis found that brand-name drug makers filed 92 percent of such citizen petitions between 2011 and 2015, although the FDA denied more than 9 out of every 10 petitions.
“Citizen petitions represent a hidden tool in (the brand-name drug maker’s) toolkit of entry-delaying activity, all to the detriment of consumers forced to pay high drug prices,” the analysis concludes. “And in defiance of Congress’s attempt to limit abuse, citizen petitions play an increasingly important role in delaying generic competition.”