While some attorneys and other observers say that drug companies often use citizen petitions as a means to delay the FDA approval of a generic drug after a branded company’s patent has expired, Pharmaceutical Research and Manufacturers of America (PhRMA) says there is only “scant” evidence that they are filed purely to block generics.
The association says companies might take their citizen petition issues to court instead of the FDA if changes that were proposed as part of Senate FDA reform legislation take effect.
The changes would not allow a petition to delay agency approval of a generic unless delay is necessary in order to protect public health. As a check on competitors, petitioners would have to verify who is making a challenge and whether they expect to be paid for filing the petition. Congress would have to receive annual reports on delays to generics based on citizen petitions.
From the September 01, 2007 Issue of MM+M - Medical Marketing and Media
