Originally published on December 28, 1999 and brought to you today as a time capsule.
President Clinton cracked down on the sale of online prescription drugs by proposing a law that requires pharmaceutical sites to get federal approval or face stiff fines.
“Use of the Internet to buy medical products is growing rapidly, and many consumers, including those in rural areas or those who can not leave their homes, benefit from the convenience and privacy of this new option,” Clinton said in a statement. “Unfortunately, the safe use of the Internet by both consumers and businesses is now being threatened by fraudulent or disreputable Internet pharmacies that sell products illegally.”
If approved by Congress, the president’s plan would give the Food and Drug Administration (FDA) new powers to review and certify hundreds of prescription-filling Web sites, along with US$10 million next year to hire one hundred investigators and to upgrade computers. Those who continue to violate the new regulations would hazard $500,000 fines for each infraction.
This action marks a significant shift in the administration’s hands-off policy toward the Internet and e-commerce. There is just one current federal law against the unlawful distribution of prescription drugs via the Internet, carrying only a $1,000 fine and a misdemeanor charge.
Viagra Concern
However, the FDA has recently become concerned with the proliferation of prescription drugs such as Viagra being sold via the Internet to patients, without them actually being examined by a doctor.
The recent case of a 53 year-old Chicago, Illinois man, who died of a heart attack after taking the impotence pill he ordered via the Internet, underscores the need for more federal regulation, according to the FDA.
Faulty AIDS Tests
In another case, the FDA uncovered the sale of illegal at-home AIDS tests that caused some with the HIV virus to erroneously conclude that they were healthy.
“Traditionally, there have been several safeguards to protect consumers against the use of drugs,” according to the White House statement. “The Internet makes it easy to bypass these safeguards. Unethical doctors can illegally prescribe pills online to consumers they have never met in states where they are not authorized to work.”
Meanwhile, opponents of federal regulations point out that the vast majority of prescription Web sites are safe, ethical and certified by the National Association of Boards of Pharmacy (NABP). They also contend that once the government gets its foot into cyberspace, innovation and efficiency will quickly give way to regulation and red tape.
The NABP has established a seventeen-step set of criteria to verify the legitimacy of online sites called the Verified Internet Pharmacy Practice Site (VIPPS), the NABP has given the award to four sites to date: Drugstore.com, CVS.com, Merck-Medco, and Planet Rx.
The FDA’s Web site includes numerous tips to help online consumers through the maze of issues surrounding prescription drugs. It recommends that consumers be very careful if they buy from sites other than those with the VIPPS.
Clinton’s Plan
If Clinton’s plan is approved, the following regulations and penalties will be enacted:
- Online pharmacies will be required to get FDA certification or face legal sanctions.
- The FDA will have the new power to subpoena the records of online sites that are under investigation.
- The FDA will be able to impose fines of $500,000 for each time a site sold an invalid prescription.
Nonetheless, even if these measures are implemented, it is still unclear how they would be enforced on Web sites that operate outside the U.S.
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