Good Ethics: FDA Panel Shows Concern for the Patient
Here is an update regarding today's final decision by the FDA panel regarding whether Mevacor should be made an over-the-counter drug as reported by
Bloomberg: "Merck & Co. and Johnson & Johnson shouldn't be allowed to sell their Mevacor cholesterol drug without a doctor's prescription, U.S. government advisers said today, signaling that future applicants need to prove the safety of selling medicines for chronic illnesses over the counter.
A committee of doctors and scientists recommended that the Food and Drug Administration deny the companies' a bid for a nonprescription Mevacor. During a two-day meeting in Bethesda, Maryland, panelists found fault with Merck's research. They said it showed patients would be confused about taking the drug.
``I am concerned that the precedent has really serious ramifications that go beyond this,'' said Nelson Watts, a doctor from Cincinnati who was one of 20 panelists to vote no, against three in favor."
I am pleased that the panel made the right decision and ethically showed beneficence to the public. In view of the ciriticisms the FDA itself is having with regard to other drug issues currently, it is doubtful that the FDA will go against the decision of the panel. ..Maurice.