Walk into any Mexican farmacia and you would probably be amazed at what you can buy over the counter without a prescription—and at the price you would pay. Cross into Canada and within minutes you will see the difference a national border makes in the cost of prescription drugs. Traveling to Britain or France? There you will find that you can pay about half as much for any drugs that you would buy here.

The irony: Many of these drugs were made right here in the United States. So why can't you walk into your corner drugstore and walk out without worrying that by paying for your medications you will not be able to pay your electricity bill this month? Or not be able to buy your kids new shoes for school?

Over the past year the pressure for the pharmaceutical industry to answer such questions has mounted as legislators, health care advocates, and presidential candidates have lashed out at the cost of prescription drugs. The heat was turned up even higher in May when Sen. Jim Jeffords, a Republican from Vermont, introduced legislation that would permit individuals, pharmacists, and wholesalers to reimport U.S.-made drugs sold in other countries.

By doing an end run around the industry's U.S. price structure, Jeffords hopes to create price competition in this country. "What this legislation will do is create competitive pressure," explains Joe Karpinski, communications director for the Senate Health and Education Committee, which Jeffords chairs. "The pharmaceutical industry isn't going to like that, but we don't think it's competition that will put them out of business. That's how the marketplace operates."

Senator Jeffords, being cautious about the public's safety, according to his staff, wrote drug-reimportation protocols into his legislation for the FDA to administer.

To say that the industry "isn't going to like that" is a delicate understatement at best. The Pharmaceutical Research and Manufacturers of America, the industry's trade association, has pulled out all stops to defeat this legislation. Lobbyists have swarmed Capitol Hill, while full-page advertisements in The Washington Post, The New York Times, USA Today, and more than 20 local newspapers and magazines throughout the country have spread the message that Jeffords's legislation would allow potentially lethal counterfeit drugs to "make their way across our borders and into our medicine cabinets."

PhRMA says the need to ensure public safety has fueled this effort. "The industry opposes this legislation because it would overturn landmark consumer protection law [the Prescription Drug Marketing Act] that Congress passed overwhelmingly in 1988," explains PhRMA spokeswoman Jackie Cottrell. "The concerns that existed 12 years ago about safety for American patients continue to be very real today, and we don't think consumer protection standards should be weakened. Secondly, while this proposal is reported to be a cost savings for American consumers, a congressional study conducted in 1988 found that the savings from any reimported medicines would only enrich the middlemen and not consumers."

The U.S. government is aware that drug reimportation could lead to an increase in counterfeit medications, and it is precisely for that reason, according to Karpinski, that Jeffords's legislation is worded the way that it is. "Recently the Justice Department brought charges against four Internet pharmacy providers for not operating within American law," Karpinski says. "And when providers get drugs offshore, there's always a risk that they aren't using a reputable operation. This is why…the reimportation must be of American-made drugs made in FDA-approved facilities. The only difference would be that these drugs [would have] a shipping label that sent them overseas and not one that sent it to, say, Michigan."

Fears about safety also led Jeffords to include an allocation to the Food and Drug Administration so that it can design and implement reimportation safety protocols. And if the legislation is passed, the FDA, says spokesman Brad Stone, is prepared "to put a process into place for expanded inspections and other safeguards."

PhRMA's Cottrell says that is fine, but it is not enough. Once a third party is involved and the manufacturer is not responsible for shipping, there is no way to know, she says, whether the medicines have been handled properly, stored at the correct temperatures, or tampered with in any way. Further, Jeffords's method of safety assurance comes at its own price. Estimates indicate it would cost about $92 million to develop and implement the new procedures his legislation would require. Whether these procedures would ensure safety, or whether wholesalers and not the public would reap the profits, remains unknown.

But is this debate really about safety or profit? Reimportation of American-made drugs at lower prices is possible only because foreign governments negotiate prices, control prices, and set profit levels for pharmaceutical companies. And some say it is time the U.S. government did the same.

PhRMA argues that "it is difficult to make meaningful price comparisons among countries because of the significant differences in the structure of their health care systems and their method of payment for pharmaceuticals." And, the association says, these prices reflect the fact that "other nations limit pharmaceutical prices or reimbursement in a manner that does not reflect the values of medicines."

But how can the values of medicines be determined? A pill's ability to save a life is invaluable, as anyone with HIV knows all too well. But pills cannot help—and have no value to—people who cannot afford them.

As part of one of the most profitable industries in the United States, pharmaceutical companies have filled their investors' coffers—and then some. Undoubtedly, medicines for people with HIV have helped fuel those profits. Five of the 12 most profitable corporations in the United States are

Pharmaceutical companies that make drugs for HIV sufferers—on whom the benefit of these medications is, of course, not lost. But neither is the cost: Prescriptions for the latest therapies can easily cost $15,000 a year. And not everyone can pay the price.

On the surface Jeffords's legislation is about pricing and reimportation. But you do not have to dig much deeper to see what it is really about. Many health advocates and legislators have been angry for years about how the pharmaceutical companies operate, the profits they make, the government tax breaks they receive for research and development, and the long-term patents they sustain. And these critics are livid that these practices continue to occur while more than 70 million individuals in the United States lack prescription drug coverage in their health insurance plans.

PhRMA agrees that the anger about the uninsured is justified but adds that it is misplaced, saying that the situation is not its fault but the insurance companies'. Moreover, PhRMA argues that the industry's profits are not only justified but necessary. "If you have a profitable pharmaceutical industry, you might get a cure for AIDS in the future," says Cottrell. "I don't know of any other industry that Americans should really want to do well. The pharmaceutical industry plows back 20% into research and development, which is more than any other industry by far. So when these companies are doing well, patients are doing even better because profitability leads to increased investment, which leads to increased research and development, which leads to new cures and treatment. If the pharmaceutical companies were struggling, we would not see the 40 new medicines that appear in medicine chests each year."

Other disagree with this line of reasoning. "This is just part of PhRMA's fog of fear," says Alan Sager, Ph.D., a professor of health services at the Boston University School of Public Health. "They speak about their business as if it were a financial house of cards that would fall apart if the government worked to create lower prices. It's a scare tactic. The fact is, U.S. drug prices are unnaturally high, and the price of pharmaceutical success is avoidable suffering and death."

Former New England Journal of Medicine editor Marcia Angell, MD, agrees. In an editorial published in the journal's June issue, Angell took the industry to task for its "apparent capriciousness of drug pricing and other practices" and called the pharmaceutical companies' response to criticisms "exaggerated or misleading…and [in some cases] simply false." Angell wrote off the idea that the pharmaceutical industry could "be considered risky" and balked at the claim that government price controls would stifle innovation and frighten investors, given the industry's profit margins and the revenue it spends on marketing.

Such accusations are not new to PhRMA. The industry's response to these and other critiques, however, tends to gloss over industry profits and instead emphasize industry expenditures. "As an industry," Cottrell says, "we are expected in 2000 to spend $26.4 billion on research and development for new drugs, which is more than the entire budget of the National Institutes of Health."

Developing new drugs is, to be sure, a lengthy process. It takes an average of 15 years for a new drug to move from the laboratory into a patient's hands. PhRMA says this process easily costs a company, on average, $500 million per drug.

But not everyone accepts this assertion. "This amount applies only to drugs originated entirely by manufacturers," says Sager. "It does not apply to the substantial number of drugs developed with NIH or other public financing in government or university laboratories. If you included those drugs, you would easily lower the average cost."

And, as Angell notes, there are clear returns and refunds on those expenditures. "The pharmaceutical industry enjoys extraordinary government protections and subsidies. Much of the early basic research that may lead to drug development is funded by the National Institutes of Health. The industry also enjoys great tax advantages. Not only are its research and development costs deductible, but so are its massive marketing expenses.… Most important, the drug companies enjoy 17-year government-granted monopolies on their new drugs—that is, patent protection."

Depending on the type and amount of prescription drug medication a person takes and the type of insurance coverage he or she has, Jeffords's legislation could help many people buy drugs they need but cannot afford. Currently more than half of all AIDS drugs are paid for by the federal government through Medicaid, the AIDS Drug Assistance Program, and Veterans Administration programs. For Americans with HIV who do not have access to the latest therapies through clinical trials, health care, Medicaid, or other drug assistance programs, this legislation could be lifesaving.

Not that the pharmaceutical companies have turned their backs on this problem. Well aware of the millions of people who cannot afford prescription drugs because of inadequate or nonexistent health insurance coverage, many companies have instituted patient assistance programs that provide free medicines. In 1999 alone these programs served 1.9 million people, including people with HIV disease.

But it is not enough to reach all people in need. The title of Angell's editorial best summed up the debate's bottom line: "The Pharmaceutical Industry—To Whom Is It Accountable?" Some say these companies are accountable only to their investors, who expect them to do exactly what they are presently doing—maximizing profits and protecting the investors' interests. Others say this is not—and cannot—be about profits. Fundamentally, these industry critics say, this is a question about moral responsibility.

Lisa Cox, senior legislative representative for AIDS Action, an advocacy network of AIDS service organizations, says her group "fully supports Senator Jeffords in his efforts to give manufacturers an important pro-competitive incentive to affordably price drugs in the American marketplace."

"We believe drug makers who benefit from taxpayer-financed research have a moral responsibility to make those lifesaving drugs as widely available as possible," she says. "Pricing vital prescription medications at the level of what the market will bear is an inhumane practice rejected by most industrialized nations."

Will using other nations' policies have an impact on pharmaceutical companies and U.S. pricing? No one yet knows. Indeed, the legislation still has to be hammered into language agreeable to opposing sides in Congress before it can come up for a vote, and some policy experts say it will not happen this session. However, even if not passed into law, the bill has clearly focused attention on the millions of people who cannot afford prescription drugs and the pharmaceutical industry's high profits.

"In the end," says Sager, "we need to negotiate a durable peace treaty with the world's drug makers that would ensure that everyone who needs drugs has them without harming drug makers' revenues or the research and development needed for new drugs."

With both sides' public relations swords drawn and ready for action, it does not look like the battle will end anytime soon.