Locking Up Life-Saving Drugs

Prescription laws make us sicker and poorer.

Kerry Howley from the August/September 2005 issue

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No Risks, Please--We're Bureaucrats

While patent expiration encourages pharmaceutical companies to bring drugs to a wider audience, a risk-averse FDA has little to gain from loosening the chains. Once it's ready to ask for over-the-counter status, a drug maker must prove that its medication meets three criteria: The indicated condition can be self-diagnosed, the drug must be safe for use without a doctor's supervision, and the label must convey proper usage to consumers. Each test hinges on how intelligent the FDA deems consumers to be. To judge from some recent decisions, it thinks we're pretty dense.

The FDA's hearings on statins demonstrate how the agency weighs factors far removed from the side effects of a drug itself. Alistair Wood, an associate dean at Vanderbilt University School of Medicine who chaired the hearings, says his fellow panelists were unsure that consumers could be trusted to identify and treat high cholesterol levels. "The issue for many on the committee was that they weren't sure you could articulate the potential benefit to consumers well enough for them to make an informed choice," he reports. "I thought that was a bit paternalistic, frankly."

The statin hearings were rife with contempt for consumers. The committee discussion veered from a study of the risks and benefits of Mevacor to the question of whether Americans were responsible enough to follow directions. A number of doctors fretted that over-the-counter statins would turn even more Americans into trans-fat-scarfing, exercise-eschewing gluttons. Frank Davidoff, a member of the advisory committee, echoed many of the other panelists when he predicted, "There may very, very well be people in the general public who begin to use over-the-counter statins who, in fact, would feel that this was a magic pill and they wouldn't have to continue to diet and exercise."

Statements like these obscure the life-saving potential of drugs like statins. According to David Silverman, a Harvard-educated cardiologist at the University of Connecticut, the drugs have set new standards for health in middle-aged Americans. "We're talking about the thing that kills more people than any other disease in America," he says. "We're talking about millions of lives saved."

The FDA's turn from safety organization to morals watchdog is especially disturbing to women's health groups, which have been waiting for emergency contraception to be made available without a prescription for years. Barr Pharmaceuticals' Plan B, a nonabortifacient morning-after pill, has been languishing in FDA limbo since 2003, despite the absence of any credible safety concerns. In December of that year, an FDA advisory committee recommended the drug as safe and effective enough to go over the counter. Forty-nine Republicans sent a letter to President Bush opposing the switch, based on the presumption that it would encourage promiscuity in young women. The FDA then announced it would delay putting the drug over the counter indefinitely.

The battle over emergency contraception has energized powerful lobbies, including Planned Parenthood and the National Organization for Women, and has led Sen. Hillary Clinton (D-N.Y.) to provoke a battle over the nomination of President Bush's pick for FDA head. Yet Plan B is just a high dose of the birth control pill, which has been prescription-only in America for more than 40 years. According to a 2004 survey by the Pharmacy Access Partnership, an advocacy group working to make contraception more accessible, one in five women report that the cost of a doctor's visit has been an obstacle to obtaining a prescription contraceptive.

A Third Way?

Drugs like Mevacor and Plan B have prompted many to ask whether America needs an option somewhere between the extremes of prescription-only and over-the-counter status. Canada, the U.K., and many European countries offer "behind the counter" options, which require patients to approach pharmacists before getting certain drugs. Statins are distributed in the U.K. this way; in France, emergency contraception is. Several panelists in the FDA statin hearings said they wouldn't vote for over-the-counter access but would happily go for a behind-the-counter option if one were available.

The FDA has said it doesn't have the authority to christen a third class of drugs. That would require congressional action, and right now there is little impetus for such legislation in the face of certain opposition from retailers such as Wal-Mart, which would object to being kept from dispensing drugs available at pharmacies. But to some extent, states are creating a de facto third class of drugs by extending limited prescribing rights to pharmacists. Alaska, California, Hawaii, Maine, New Mexico, and Washington currently offer emergency contraception behind the counter, and similar bills are pending in several other states.

In the absence of any evidence that behind-the-counter screening increases consumer caution, some doctors see this option as little more than a way to make skittish regulators more comfortable with the transition to over-the-counter status. In 1995, when the General Accounting Office (GAO) weighed the possible benefits of a third class of drugs, it found no evidence that such a regime increases consumer safety.

State rules for emergency contraception are a way of skirting restrictive federal laws, but they're far from perfect; some pharmacists have roused the ire of women's groups by refusing to fill prescriptions on moral grounds. And while the behind-the-counter trend seems to be moving toward easier access, it can also lurch backward. In January Sens. Dianne Feinstein (D-Calif.) and Jim Talent (R-Mo.) introduced a bill that would put Sudafed and other cold and allergy remedies containing pseudoephedrine behind the counter and require pharmacists to keep a log book of purchasers to combat the production of methamphetamine. Oklahoma, Illinois, and Iowa already have laws restricting the sale of such medicines, and similar legislation is pending in 20 states across the South and Southwest.

A behind-the-counter option won't address the fact that it's generally not in drug manufacturers' interests to increase access to their products as long as patents are in force. Were insurance companies and advocacy groups permitted to force a switch for drugs that meet FDA criteria for over-the-counter medications, far more hard-to-get drugs might be lining pharmacy shelves. But that's a thorny issue the FDA doesn't want to address. "It's not clear whether that's legal," explains David Hilfiker, a project manager at the FDA's over-the-counter drugs division.

FDA spokesperson Kathleen Quinn says a decision is pending, but Hilfiker says he knows of no decision-making body currently trying to clarify the issue. Without a definitive answer, the situation remains static.

An alternate system would automatically switch a drug once it's become an accepted part of the health care system. University of Chicago economist Sam Peltzman has suggested that there be a "rebuttable presumption" that any drug that has been prescribed 100 million times should go over the counter. Drugs like antibiotics--for which there are valid concerns that overuse would threaten public health--might stay prescription-only, but most heavily used drugs would be freely available after a defined period.