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WASHINGTON -- American Web sites selling medication without requiring a valid prescription are proliferating and represent a "dark and dangerous corner of the U.S. health care system," the House Committee on Government Reform was told Thursday morning.
Currently, states have the primary regulatory control over medical practices and pharmacies. Under many of these laws, to receive a prescription drug, a patient generally must be examined by a licensed health care practitioner who determines the appropriate treatment and issues a prescription for a drug approved by the Food and Drug Administration (FDA).
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The patient then has the prescription filled by a registered pharmacist working in a licensed pharmacy that meets state standards. The prescription may also authorize refills.
Many of the "rogue" pharmaceutical sites, however, do not require a prescription to dispense drugs otherwise requiring a prescription. In other cases, they require consumers to fill out a medical questionnaire that may or may not be reviewed by a licensed doctor.
Legitimate online pharmaceutical sites, on the other hand, comply with state and federal laws governing the practice of pharmacy.
According to the FDA, consumers buying prescriptions drugs from rogue pharmaceutical sites may be buying expired, subpotent, contaminated or counterfeit products; incorrect dosages; wrong or contra-indicated drugs; or medication without adequate directions for use.
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"The growth in online drug sales by reputable pharmacies has provided significant benefits to consumers," William K. Hubbard, the FDA's associate commissioner for policy, planning and legislation, told the House panel. "Online drug websites, however, also present risks to purchasers and unique challenges to regulators, law enforcement officials and policy makers."
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Hubbard said millions of Americans used the Internet last year to obtain valid health information and that many reputable Web pharmacies provide consumers seeking prescription drugs with a measure of safety, privacy and convenience. These online pharmacies, Hubbard said, will "undoubtedly" remain a vital component in the effective delivery of health care.
"The Internet also creates a new marketplace for illegal activity such as the sale of unapproved drugs, prescription drugs dispensed without a valid prescription, or products marketed with fraudulent health claims," Hubbard said. "In many cases, the FDA cannot provide consumers with any assurance that the drugs purchased over the Internet were manufactured under current good manufacturing practices requirements even if the website appears to be based in the U.S."
Cracking down on the rogue sites has so far proved problematic. Authorities have trouble tracking down the illegitimate sites because many do not disclose identifying information, change their names and appearances often, and sometimes disappear without a trace.
"Accountability is impossible when the violators cannot be identified and located," Tom Davis, chairman of the House Committee on Government Reform, said.
The committee is considering legislation that would require all U.S.-based pharmaceutical sites to carry identifying information about the site or the prescriber involved with the site.
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