Pharmaceutical companies have often used legal loopholes to “game the system” and thereby extend the 10 years of patent exclusivity once their drug hits the marketplace. On October 2, FDA Commissioner Scott Gottlieb announced a proposal to close one such loophole in the citizen petitions process, which allows individuals and community organizations to ask the FDA to change health policy. Drug companies have been accused of using citizen petitions to delay approval of generic competitors. In fact, most such petitions are filed by drug companies against other drug companies, according to a May 2016 study in PLOS One.
“If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response,” Gottlieb said in his statement.
The guidance has some teeth in that it allows the FDA to refer the matter to the Federal Trade Commission, which oversees anticompetitive business practices. The agency cautions that it will not shrink from calling out companies suspected of taking advantage of legitimate means that might impede competition that could drive down consumer costs.
Gottlieb says that the proposed revision, for which there will be an opportunity for public comment, would also speed up the review process for citizen petitions, which often slow down the approval of generic drug applications.
Under the revision, the FDA would make their decision on citizen petitions within 8 to 10 months. If they receive a petition while a product application is already under review, and the review’s due date falls within the next 150 days, the agency would expect to respond to the petition within that timeframe. Gottlieb stressed that the FDA would continue to ensure that any scientific and regulatory issues raised in a petition are examined prior to product approval. As citizen petitions sometimes raise relevant concerns, the new approach is expected to reduce approval delays in certain circumstances simply by a petition having been submitted.
2017 was a record year for the FDA, with approval/tentative approval of more than 1,000 generic drug applications. They are on a similar track for 2018.