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Pharmaceutical disobedience

January 28, 2009

Consumers, officials break obscured drug laws

Healthcare consumers, benefits managers, and even government officials are using the internet to buy unapproved prescription drugs illegally, according to a report to be published in the International Journal of Electronic Healthcare.

Daniel Lorence of Penn State Center for Technology Assessment, at University Park, Pennsylvania, suggests that the phenomenal growth of the internet as an information source for people seeking medical and health information is being paralleled by growing civil disobedience as healthcare consumers turn to related outlets to purchase the prescription drugs they want directly, that may be otherwise unavailable from their healthcare providers.

"This phenomenon carries important social and policy implications as the delivery of healthcare continues to defy national borders and policies," says Lorence. "The most recent (2002) US Census data suggests an estimated 43.6 million US citizens did not have health insurance for the previous 12 months," Lorence points out. These numbers are likely to grow during a period of economic recession as well as the number of people who are simply under-insured or whose insurance precludes access to particular treatments.

Lorence adds that it is no surprise that US consumers are more sensitive to the higher prices they pay for medications relative to other developed countries. The price gap between nations for prescription drugs has widened since 2000 and there is no sign of it narrowing in the foreseeable future.

"Such differences in prices between the USA and the seven wealthy nations, including Canada, largely reflect differing public policies on drug pricing and costs," explains Lorence. The fundamental reason for this gap is that the US government allows drug makers to raise prices freely whereas other nations limit prices and costs through price negotiations, across-the-board price cuts, reference pricing, profit caps, putting drug spending on a budget, and other methods.

Given this set of circumstances, cheap and readily available prescription drugs via the internet becomes an attractive proposition for countless underinsured Americans.

The purchase of discounted prescription drugs from Canada, via the internet or direct travel across the border, appears as the most long-standing innovation adopted by American seniors and a growing number of health benefits managers in meeting their needs, says Lorence. The Food and Drug Administration (FDA) is trying to prevent such civil disobedience through various actions. Nevertheless, a growing number of seniors and benefits managers continue to defy the FDA assisted to some extent by off-message government officials and even policy-makers.

The FDA policy to be found on its website (http://www.fda.gov/ora/import/traveler_alert.htm) states: "Avoid purchasing any drug products that are not approved for sale in the U.S. (including foreign-manufactured versions of U.S. approved drugs). FDA cannot assure that these products conform to the manufacturing and quality assurance procedures mandated by U.S. laws and regulations and, therefore, these products may be unsafe. In addition, such products are illegal in the U.S. and, therefore, may be subject to entry refusal-"

"The FDA continues to obscure the legality of this issue, while still threatening to prosecute consumers," says Lorence.

Inderscience Publishers