Drugs

We are writing to express our strong support for the FDA’s proposal to upclassify both surgical mesh for POP repair and surgical mesh instrumentation. This change will help to ensure that devices intended to improve women’s heath are supported by evidence of safety and effectiveness. We would also like to express our strong concerns that the agency has not proposed reclassification of surgical mesh for stress urinary incontinence (SUI) from class II to class III.

We applaud FDA’s efforts to clearly and effectively communicate risks and benefits to consumers in direct-to-consumer (DTC) advertisements.  However, we are concerned about this study’s definition of “serious and actionable” risks, the diversity of the population being studied, the administration of the study in an online setting only, and the timing of the major statement in the ad (at the end of the ad instead of the beginning or middle).

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.

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.