The proposed rule is needed to help safeguard the health and safety of patients and consumers. In addition to the specific provisions of the rule, legal accountability is a powerful incentive for generic drug manufacturers to take post-market monitoring more seriously. We strongly urge the FDA to adopt the proposed rule in its current form as soon as possible.
Prescription and over-the-counter drugs can be life-saving or harmful. Our goal is to improve the safety and effectiveness of drugs sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks.
We recognize the need for new drugs to reach patients with serious or life-threatening diseases. However, based on our knowledge of existing accelerated approval strategies and the widespread off label use of prescription drugs, we have grave concerns about the creation of a new, vaguely defined pathway intended to approve drugs for limited populations.