PhRMA: petitions don't delay approval
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.