We strongly support the use of generic drugs and find it disturbing that generic drug manufacturers are putting their financial interests before the health and safety of patients. Members of the coalition 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 are writing as members of the Patient, Consumer, and Public Health Coalition to express our strong concerns about the approval standards considered and the conflicts of interest apparent at the December 5, 2014 FDA meeting of the Anti-Infective Drugs Advisory Committee (AIDAC) regarding a new combination antibiotic product, ceftazidime-avibactam (CAZ-AVI).
We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses from the Chantix label.
We strongly urge the Food and Drug Administration (FDA) to withdraw its draft guidance proposing to allow pharmaceutical firms to distribute to health care providers and facilities scientific medical literature suggesting that the risk information for prescription drugs and biological products are less than what is stated in the FDA-approved product labeling. The guidance has the potential to cause confusion and greatly harm patients.
We are writing to comment on various aspects of the proposed rule to extend FDA’s jurisdiction to tobacco (including made or derived from tobacco) products other than cigarettes, including e-cigarettes. It is essential that the proposed rule be strengthened, since nicotine is highly addictive.
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.