Why the American Association of Physicians and Surgeons Filed Lawsuit Against FDA’s Approval of OTC Plan B.
Facts presented in a lawsuit against the FDA reveal that it had skirted laws and regulations which were originally put into place to ensure all drugs made available to the public are safe and effective. What is most alarming to me in this unprecedented move by the FDA is the approval a more potent formulation of over-the-counter Plan B than those by prescription. The FDA never required or requested any manufacturer information on the safety and efficacy of the higher doses when taken by girls during puberty. Other actions by the FDA which ignored the measures normally put in place to protect the safety of the public include:
A misleading label which does not provide the legally required disclaimers to delineate what it can and cannot do, which is required for ALL MEDICATIONS.
Its failure to conduct the necessary rulemaking process which is required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.
Its approval of OTC Plan B even after it found that it was unsafe for girls to use this product without medical supervision, as denoted by the fact it is prescription- only for those under 18.
The number of drugs which have failed in FDA approval since the Vioxx incident several years ago is unprecedented. The FDA and the pharmaceutical industry were forced to adhere to the public’s demand for safe and effective drugs, and as seen in recent months, if there are any hints of a concern over the safety of a drug - the FDA and the press are quick to respond. This issue of FDA approval of OTC Plan B is not only a concern for morality, but it is also a concern over women’s health and safety and this concern is now being expressed by those in the medical community. We have witnessed the corruption of a process meant to ensure product safety and efficacy by an institution which has been entrusted with the responsibility of protecting the public. The FDA has now betrayed that trust by allowing a politicially motivated agenda to trump the responsiblity they have towards those who could be potentially harmed by Plan B. The American Association of Physicians and Surgeons understand the significance of this irresponsible move by the FDA, which contradicts all of the rules and regulations, and yes even common sense, instituted for the purpose of public safety. That is why they have chosen to bring the FDA to court. In this instance, the FDA took it upon themselves to establish their own protocols in leiu of statutory and ethically mandated regulations because they caved into political pressure. This is totally irresponsible and should be of major concern to us all.
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