President Bush is set to sign legislation that will help the federal government crack down on hundreds of rogue Internet pharmacies that peddle controlled substances like the painkiller Vicodin or the stimulant Ritalin.The bill reflects growing concern among parents and public-health experts that certain online pharmacies enable almost anyone to purchase drugs with a few mouse clicks and without seeing a doctor or getting a valid prescription. Experts believe the Web sites are fueling an increase in the abuse of prescription drugs, especially among teenagers.
The legislation, approved by Congress last month, aims to make it harder for people to obtain the drugs by prohibiting online pharmacies from dispensing medications to anyone without a valid prescription from a doctor who has examined the purchaser in person at least once. It would have little effect on legal online pharmacies, such as drugstore.com and the sites of pharmacy chains Walgreen Co. and CVS Caremark Corp. that already impose such rules on their customers.
Regulators say the new law is intended in part to strengthen the federal government's ability to enforce existing statutes and make clear how they apply to the Internet. "This is really making explicit what has been implicit," said Sen. Dianne Feinstein, a California Democrat and the bill's lead sponsor in the Senate. "We've tried to close this loophole by essentially addressing this problem of controlled substances being sold without any medical oversight or prescription."
The bill has limitations, however. For one, it's not aimed at online pharmacies based outside the country. Also, the bill also doesn't address non-controlled prescription drugs, such as the erectile-dysfunction drugs Viagra and Cialis, hair-loss drug Propecia, painkiller Celebrex and muscle relaxant Soma that are popular on rogue sites. Finally, the bill does not create new requirements for Internet search engines, credit-card companies or package-delivery concerns whose services are used in online pharmacy transactions.
Abuse of prescription medicines is beginning to rival that of illegal drugs as a public health worry. From 1992 to 2006, the number of people who admitted abusing controlled prescription drugs doubled to 15.8 million, according to the National Center on Addiction and Substance Abuse at Columbia University. That is more than the combined number of people who reported abusing cocaine, hallucinogens, inhalants and heroin.
Teenagers are especially vulnerable. In 2006, 2.2 million teens between ages 12 and 17 admitted abusing a prescription drug in the past year. While the role of rogue online pharmacies is hard to quantify, Joseph Califano, president of the center at Columbia, says they are a "significant" part of the problem, in part because college students can get online orders sent to their mailboxes without parents' knowledge. Teenagers also get drugs out of their parents' medicine cabinets, he says.
The Drug Enforcement Administration says that a relatively small percentage of people get controlled drugs illegally over the Internet, but that they frequently get them in large quantities -- 100 to 120 pills at a time, compared to just a handful from friends or pilfered from pill bottles at home. The DEA also believes these pharmacies are an "upstream" source of the drugs, meaning they sell them to individuals who then deal them to others.
Potential for Abuse
Controlled substances are policed by the DEA because of their potential to be abused or lead to addiction. Those popular on the Internet include stimulants such as Adderall and Ritalin, painkillers such as Vicodin and OxyContin, depressants such as Xanax and Valium, and the weight-loss drug phentermine.
Pharmacy Web sites commonly offer questionnaires as the primary hurdle for getting the drugs, and often steer patients toward answers that provide medical justification of a prescription for whatever drug they are seeking, says Carmen Catizone, executive director of the National Association of Boards of Pharmacy, an umbrella group of state pharmacy boards. Some also employ doctors who review the questionnaires and approve hundreds of prescriptions per day, he says, adding that these doctors are commonly paid per prescription approved.
In addition to insisting on a valid prescription from a doctor who has examined the patient in person at least once (with certain exceptions for telemedicine), the new legislation requires pharmacies to specify in their registrations with the DEA if they're selling controlled substances online, and to place clear language on their home pages that they comply with certain of the bill's provisions.
They also must list information, including names, addresses and contact information for the pharmacies and pharmacists associated with the sites, and doctors affiliated with the sites. Prison sentences for illegally distributing many controlled substances are increased.
Patrick Egan, a partner at the Philadelphia law firm Fox Rothschild LLP who has defended Internet pharmacies, noted that it's hard to regulate operations based in other countries. Moreover, Mr. Egan, who provided congressional testimony opposing the bill, said in an interview that there needs to be "meaningful discussion about whether this particular model for delivery of drugs might have some usefulness in our society." He cited instances where online pharmacies help people who can't afford to see a doctor or live in remote areas.
Several states have beefed up their own laws to crack down on online pharmacies. For instance, Arkansas now prohibits Internet sales of prescription drugs without a doctor having physically examined a patient at least once. However, "It is very difficult for us to do something to someone out of state," said John Kirtley, assistant director of the Arkansas State Board of Pharmacy. A federal law "is going to put more of an onus on them, from a nationwide level, to do something about it."
The DEA has already shut down a number of online pharmacies, and has also clamped down on practices of major distributors of prescription drugs. Last week, drug distributor Cardinal Health Inc. said it had entered a $34 million settlement with the DEA and seven U.S. attorneys' offices over allegations it had failed to report to the DEA suspicious orders of hydrocodone, a main ingredient in Vicodin, it distributed to pharmacies that filled prescriptions originating from rogue pharmacy Web sites.
Cardinal spokesman Troy Kirkpatrick said the company, which did not admit wrongdoing, has beefed up a system to catch such transactions by flagging unusually large orders of controlled substances from pharmacies and reporting suspicious orders to the DEA and state boards of pharmacy. The company is training employees to be more familiar with their customers' buying habits so they can catch behavior that's out of character, Mr. Kirkpatrick said.
Another major distributor, McKesson Corp., in May entered a $13 million settlement with the federal government over similar allegations. The company denied wrongdoing.
The National Association of Chain Drug Stores, a trade group whose members include Walgreen and CVS, supports the bill. Rogue sites "were sullying the reputation of the entire industry," said Paul Kelly, vice president of federal government affairs for the group. Drugstore.com, which also supports the bill, said it would not require the company to make significant changes to the way its site operates, beyond adding some disclosures to the home page.
The National Association of Boards of Pharmacy runs a program to accredit online pharmacies as "Verified Internet Pharmacy Practice Sites," or VIPPS, and lists them at www.nabp.net. NABP also lists "not recommended" sites, describing them as those that appear to be out of compliance with laws or NABP standards.
