A world of difference exists between prescribing medications and dispensing them. The White House is justifiably concerned that some drug-dispensing Web sites are doing both -- a practice that could compromise the health and welfare of consumers.
Recently, President Clinton announced a plan to require Internet sites, under the threat of stiff fines, to get federal approval for selling prescription drugs on-line. The proposal also would make it easier for the government to stop online sales of unapproved drugs, counterfeit drugs and products promoted with fraudulent claims. The regulations also are intended to stem drug sales conducted without a doctor's visit or prescription and sales of prescription medicine to minors.It makes sense to give the Food and Drug Administration broader latitude to address rogue operations, since the only pertinent federal law on the books is a misdemeanor which carries a fine of just $1,000. Clinton's proposal envisions that online pharmacies must obtain FDA certification and that fines of $500,000 could be imposed each time a site sold a prescription drug without a valid prescription. Even with new enforcement tools, the scattershot nature of online businesses will make it difficult for federal regulators to affect significant change in this arena.
For instance, a University of Pennsylvania researcher located 86 Web sites that sold Viagra without requiring a doctor's visit or a prescription. Twenty-two of the sites appeared to be based outside the United States, which makes it difficult for state and federal authorities to take action against them.
Yet, regulators need to intervene when they can because the practice of self-medicating is a high-risk proposition. The reason the federal government determines which drugs require prescriptions is these drugs are for serious medical problems and can cause serious side effects.
Certain U.S. Web sites tout these drugs: Viagra, highly risky for certain men; Valtrex, which treats genital herpes but can kill patients with weak immune systems; Meridia, a diet drug that requires doctor monitoring because it can raise blood pressure; and the diet drug phentermine, a controlled substance considered too dangerous to be widely dispensed.
As the Clinton administration makes a move to regulate the online pharmaceutical business, regulators must be drafted so that legitimate business interests are protected. Reputable companies insist on prescriptions from the patient or directly from a physician. Like other online shopping services, pharmacy web sites offer quality prescription drugs at lower prices, with the added bonus of convenience.
Since the practice of medicine and pharmacy are regulated by the states, some industry officials balk at the suggestion of an added layer of regulation. But the problem comes when Internet pharmacies bypass traditional safeguards against the use of unsafe or inappropriate drugs. The new rules are aimed at the fly-by-night businesses, not the legitimate concerns that, because of their due diligence, can look forward to a long history delivering services via the Web.
This is not an instance where the federal government can simply advise buyers to beware.