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.
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.