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FDA meets to discuss new 'behind-the-counter' drug class

According to US media reports, the FDA is considering creating a third category of drugs to make some medicines available without a prescription, but only after consultation with a pharmacist.

 According to US media reports, the FDA is considering creating a third category of drugs to make some medicines available without a prescription, but only after consultation with a pharmacist.

The "behind-the-counter" (BTC) class of medicines to supplement prescription and over-the-counter drugs will be debated during an FDA meeting to be held on 14 November 2007. The reasoning behind the idea is that a pharmacist-controlled category of drugs could increase patient access to certain treatments, but still keep them from misusing or abusing the drugs.

The move echoes prescribing changes in the NHS, where pharmacists and other "non-medical" staff, such as optometrists and physiotherapists, will be able to prescribe medicines to patients in order to improve access to treatments.

In an interview with US online publication, The Plain Dealer, the FDA's director of pharmacy affairs, Ilisa Bernstein, said: "This is an idea that has been discussed for many years and we want to bring to the forefront right now. Health care delivery has changed, and we must look to see how we can increase access to safe and effective drugs to patients who need them.

Now is a good time to have discussion on a more public level."

Independent community pharmacists support the FDA notion, but doctors are concerned about a loss of control, while OTC drug manufacturers fear profits could disappear if products are "hidden" behind the counter.

Community pharmacists say they have the expertise to counsel consumers on proper use of medications, and they see the proposed BTC class of drugs as a way to increase their economic viability as competition from large chain drugstores and increase.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the leading US trade group for ethical pharmaceutical companies, remains undecided.

However, the American Medical Association (AMA) said there is no need for a third class of drugs, suggesting lack of proper medical oversight could pose risks for patients. A board member said that if a drug were considered to be unsafe without supervision, a doctor should be responsible for supervising the use of that drug.

The FDA says it will not move ahead with a BTC plan or even suggest the specific kinds of drugs that might fit the bill. The agency says it wants input on how and if such a system can work. One possible candidate for BTC status could be cholesterol-lowering statin drugs.

In 2006, the FDA allowed the Plan B emergency contraceptive to be available directly from pharmacists for women aged 18 years and older and by prescription-only for those who are younger. US Congress also recently required that former OTC products containing the decongestant pseudoephedrine be available only from pharmacists because of concern about use of the product in making the illegal drug methamphetamine.

A number of pharmaceutical companies have sought to sell their prescription drugs OTC, such as Merck & Co with its cholesterol drug, Mevacor (lovastatin), but this was rejected by the FDA. The company recently renewed its request for OTC sales, which will be reviewed by an FDA advisory panel on 13 December 2007. Pfizer also revealed it was seeking OTC status for its sexual dysfunction treatment, Viagra (sildenafil) , another potential candidate for BTC status.

30th September 2008

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