To ease fears at the FDA, pharmacists have suggested a "transition class" in which drugs would be sold behind the counter for a predetermined period of time and later granted full nonprescription status. There is some precedent for this in the Australian state of Victoria, where officials watch for adverse effects while drugs are sold only in pharmacies and then consider whether to shift a drug to full nonprescription status. But drugs tend to get stuck in the transition class. According to the GAO report, there is no extant prescription regime in which a transition class facilitates a timely jump to nonprescription status.
Power to the Consumers
For individuals in the throes of chronic illness to couples looking to energize their sex lives, self-care is an increasingly popular option. American consumers have voiced their desire for more options by supporting a $15 billion industry in over-the-counter meds, responding strongly to direct-to-consumer drug ads, and encouraging a robust generic drug industry.
"People are asking for more prescription drugs by name, and buying more over the counter," says Tamu Johnson, an analyst with marketing research group Mintel International. "People are becoming more confident about their ability to treat themselves."
Yet lifesaving and lifestyle drugs trickle onto pharmacy shelves remarkably slowly. The last switch was made in 2003, when the heartburn treatment Prilosec went over the counter. Since then only two drugs have been proposed for the switch, and both were rejected. Until Americans demand more say in what drugs they can buy and where they can buy them, they'll be forced to pay more, get less, and restrict notions of self-care to a few medicines that the pharmaceutical industry and the FDA let fall from their grip.
FDA regulations force companies to wait four years before reapplying for over-the-counter status, so Mevacor will be available only by prescription until at least 2008. Meanwhile, the country is saddled with a massive cholesterol problem.
"There is clear evidence that [statins] are effective in lowering cholesterol, clear evidence that they are effective in lowering the risk of heart disease, and there is clear evidence that large numbers of people right now are not taking the drugs who appropriately should be taking these drugs," explains Wood, who chaired the FDA panel that rejected Mevacor but dissented from the majority opinion. "Lowering the population's cholesterol by just a little bit produces a huge public health advantage."
For Janice Alston, the uninsured nurse's assistant, the barriers to medication aren't about public health advantages or macroeconomic efficiency; they're about a lack of control over her medical care, and a system, purportedly in her interest, that places barriers between her and lifesaving medication.
"I'm just waiting until the time comes when I can afford the medicine I need," she says.
Facing a system fraught with its own afflictions, the wait may be a long one.
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