US regulators need new powers to fight abuses by Internet pharmacies, which Congress didn't anticipate in enacting the 1938 law governing much of the Food and Drug Administration's authority on medicines, lawmakers say.
Democrats and Republicans in the US House have introduced at least four bills seeking more regulation of Web pharmacies. Many of them don't require prescriptions for drugs such as Pfizer Inc.'s Viagra and addictive painkillers, the FDA has said.
A House bill from Virginia Republican Tom Davis and California Democrat Henry Waxman would establish a national standard for valid prescriptions for sales over the Internet. This would make it easier for the FDA and state officials to crack down on websites selling dangerous products, Waxman said.
"Enforcement efforts are complicated: A website operator can be in one state, the pharmacy in a second state," and the doctor in a third state, Waxman said at a hearing in Washington. "This may bring three different state standards into play."
Internet pharmacy sales, including prescription drugs and over-the-counter medicines such as aspirin, will more than double this year to $5 billion from $1.7 billion last year, according to Jupiter Media, a New York research firm.
Drugstore.com Inc., which had about $135 million in Internet pharmacy sales last year, said it supports the Waxman-Davis effort to increase regulation of Internet pharmacies. The Bellevue, Wash., company urged legislators to take a further step and create a uniform certification standard.
"There are an alarming number of bad actors posing as legitimate online pharmacies," said Peter Neupert, Drugstore.com's chairman, in testimony submitted to the House Committee on Government Reform.
The committee, led by Davis, held a hearing on the bill that he sponsored with Waxman, which calls for revisions to the Food, Drug and Cosmetic Act of 1938 the outlines much of the FDA's responsibility for medicines.
The bill asks that the law be changed to require Internet pharmacies to give information about the license and location of their pharmacists.
The bill is under the control of the House Energy and Commerce committee, which oversees the FDA. Three bills with similar provisions sponsored by Ohio Democrat Sherrod Brown, Michigan Republican Bart Stupak and Georgia Republican Charles Norwood also have been referred the health subcommittee.
The Energy and Commerce committee is conducting a probe of Internet pharmacies. The results of this investigation might shape any legislation moving from the committee.
The FDA needs expanded authority to keep up with the growing threat posed by some Internet pharmacies, said William K. Hubbard, the agency's associate commissioner for policy and planning.![]()