Behind-the-Counter Drug Plan Needs More Time, Research and Input: Questions of Safety, Cost and Need Persist

Statement of Dr. Sidney Wolfe, Director of the Health Research Group at Public Citizen

Oct. 4, 2007 -- The idea of behind-the-counter-drugs is not new. The Food and Drug Administration (FDA) has previously considered creating a third class of drugs - an intermediate step between prescription medications and over-the-counter drugs - but has not supported the idea, citing the need for more research. That need still exists today.

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It’s been 12 years since a U.S. General Accounting Office report, commissioned by Congress, raised serious questions about the usefulness of adding another class of drugs. The report looked at how similar systems - in which pharmacists distribute certain drugs without a doctor’s prescription -were faring in 10 countries. The possible risks of behind-the-counter sales, due to inadequate counseling by pharmacists, the costs, usefulness and logistics of adding this third layer of distribution were foremost among the concerns.

There’s little evidence that these concerns have been addressed. Many questions still remain unanswered. Will pharmacists have the training and the time to explain the drugs and side effects to patients? Who will pay for that training? Will this third class pull more from drugs currently sold over the counter or from those requiring a prescription? And will drug companies push to get their current prescription products into this class to avoid regulation? Will behind-the-counter availability effectively turn the drug store counter into a vending machine, free from doctor’s oversight? The FDA needs to put more research behind the plan before it tells Congress it’s OK to put more drugs behind the counter.

Source: Public Citizen