GOVERNMENT & POLICY
NOSE KNOWS At Dulles Airport outside of Washington, D.C., a Customs Service canine enforcement team inspects arriving international mail for illegal pharmaceuticals purchased over the Internet.
DRUGS ONLINE FACE SCRUTINY Despite government efforts, online drug sales without prescriptions have skyrocketed BETTE HILEMAN, C&EN WASHINGTON
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LECTRONIC COMMERCE HAS TWO I
faces. One is convenient, efficient, and enables speedy delivery of goods to remote areas. But there is a dark side. With the anonymity possible on the Internet, ecommerce can abet fraud and traffic in goods that are illegal or substandard. The two faces of buying pharmaceuticals online have become very obvious over the past year. The bright side: Ordering drugs online is convenient for people who are pressed for time or homebound, and in some cases, it saves money A minority of online pharmacies operate in the same manner as mail-order drugstores and adhere to the standards of state licensing boards. The dark side: Consumers can buy drugs from hundreds of Internet sites without valid prescriptions. They merely fill out a simple online questionnaire, click on the chosen drug, and supply credit card information. In many cases, there is not even a questionnaire. As these Internet drugstores have pro- I HTTP://PUBS.ACS.ORG/CEN
liferated over the past few years, federal and state agencies are spending increasing amounts of time and money to stop these illegal sites from harming unsuspecting consumers and to halt these rogue shops altogether. DRUGS FROM Internet pharmacies often arrive in plain brown envelopes containing unlabeled, damaged boxes of pills. Also, w i t h o u t a valid prescription, patients risk taking drug combinations that could cause serious or fatal interactions. Furthermore, many of the drugs sold from foreign Internet sites are out of date, counterfeit, improperly stored, or unapproved by the U.S. Food & Drug Administration. "Significant potential for injury exists when prescriptions are issued without adequate review of the consumer's medical history or when unapproved drugs are sold to consumers over the Internet," according toJodie Bernstein, then-director of the Federal Trade Commission's Bureau of Consumer Protection, who spoke at ajuly
30,1999, hearing of the House Committee on Energy & Commerce. Buying and selling prescription drugs without a prescription is illegal in the U.S. It is also illegal to import US.-manufactured drugs that have been exported unless a 90-day supply of the drug is purchased from a foreign pharmacy and hand-carried into the U.S. There is only one way consumers can legally import a prescription drug into the U.S. by mail. If they have a life-threatening disease, such as AIDS or cancer, and find that no US.-made drug helps, they can work with a physician and order by mail a small amount of any drug product that is available only in another country So if the Customs Service detects a package of prescription drugs mailed to a resident of the U.S., there is a small chance it could be coming in legally Despite government efforts to put socalled rogue Internet sites—those that sell prescription drugs without a prescription—out ofbusiness, sales from such sites have increased dramatically and are likely to expand. "The problem of drug sales from rogue sites is certainly not getting better," says Carla J. Stovall, Kansas attorney general. Jupiter Communications, which collects data from Internet businesses, says annual online drug sales are likely to increase from $23 million to $1 billion in a few years. Some sales will be from legitimate U.S. sites, but many are expected to be from foreign and domestic rogue sites. One problem with policing online pharmacies is that states have sole jurisdiction. If a state attorney general puts a Web pharmacy out of business in one state, it usually moves to another where the first state's prosecuting attorney general has no jurisdiction. "What we found is, if you sue one website, they'll change and do business with a modified name in another state," says Stovall, who heads the National Association of State Attorneys General. Federal legislation is needed to provide national injunctive relief, she says, so that if a state attorney general shuts down a website in one state, "it would apply to all states." Such legislation was introduced a year ago but has not been reintroduced in the current Congress. Another hurdle to fighting rogue online pharmacies is that most consist of many shell corporations or businesses, Stovall says. "What we found is that we have to go through layers and layers to get to the people who are violating the law," she says. Currently, most online pharmacies do not C&EN
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GOVERNMENT & POLICY include addresses or telephone numbers on their websites. A third problem is that online pharmacies are often based in foreign countries, particularly in Canada, Mexico, Thailand, China, and Switzerland. FDA and state attorneys general have no direct jurisdiction over foreign sites. Another difficulty is that these rogue online drugstores, whether foreign or U.S. based, do not usually maintain a single website. 'About a year ago, we did a comprehensive review of the Internet and found
that most sites have multiple links, an average of about nine links," says Tom McGinnis, FDA director ofpharmacy affairs. 'The links looked like they were competing against each other, yet they were all coming off the core site," he explains. If one site was shut down, one of the links would take its place, he says. "When a site owner thinks law enforcement is closing in on them, that site just disappears, and a week or so later it will open up under another name." The primary drugs sold online from
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rogue pharmacies are the so-called lifestyle drugs—for example Viagra, Propecia, and Xenical. But increasingly, people are also making online purchases of hormones, antibiotics, anticancer pills, and narcotics, such as OxyContin, as well as highly potent and dangerous anabolic steroids used to gain a competitive advantage in sports. Some foreign sites, such as Overseas Pharmacy Connection, offer more than 1,000 different drugs, including narcotics, all without prescriptions. ALTHOUGH IT is clearly illegal for a U.S. citizen to purchase a prescription drug or a narcotic online, the odds of getting caught are slim. "Detecting prohibited pharmaceuticals among the tens of millions of parcels passing through our mail facilities each year presents a massive challenge," says Elizabeth G. Durant, executive director of trade programs at the Customs Service. "Our limited resources require a risk management approach, with which we utilize advance intelligence, records of past seizures, and other factors to locate packages that present the most significant threat." "Typically, Customs will not arrest someone in the U.S. who has ordered a two- or three-month supply of prescription drugs for their own use, unless it is a narcotic," says Kevin Bell, spokesman for the Customs Service. The federal government and some private groups are engaged in wide-ranging efforts on many different fronts to put a stop to sales from rogue sites. FDA has a prominent website, which warns consumers against purchasing drugs from sites that sell without prescriptions. Some, but not all, manufacturers of popular drugs have placed on their home pages warnings about purchasing online and links to the FDA website. For example, the website http://www.propecia.com maintained by Merck includes the FDA link. The National Association of Boards of Pharmacy has established a certification program for online pharmacies. Those Internet drugstores that meet 17 strict criteria, including requiring valid prescriptions, are eligible for certification by the board. So far, just 13 pharmacies out of a total of 300 to 4 0 0 have been certified. To try to assess the quantity of prescription drugs coming by mail into the U.S. from foreign-based sites, the Customs Service and FDA set up a pilot program at the Carson mail facility in Los Angeles. It ran for 24 days in January and February. Over that period, FDA found 721 parcels containing drugs, Durant said. Of these, HTTP://PUBS.ACS.ORG/CEN
9 3 % were denied e n t r y and 6% were released for delivery At that rate, if all prescription drugs were detained at all 14 international mail facilities, Customs would detain about 3,000 packages per week, clearly an unworkable approach, she said. In another operation performed a year ago, Customs initiated a pharmaceutical interdiction program called "Operation Safeguard" at international mail branches at Dulles Airport in 'Virginia and at Oakland International Airport in California. It found that 80 to 9 0 % of the pharmaceuticals that enter the U.S. via the mail in both wholesale and retail quantities violate FDA or Drug Enforcement Administration (DEA) requirements, Durant said. Many of the drugs were found to be counterfeit, expired, unapproved by FDA, substandard for purity and quality, or manufactured in facilities that are not properly regulated. In this operation, Customs seized one 3,000-tablet shipment of a counterfeit drug with an expiration date of 1980. "Buying online from overseas websites is like playing Russian roulette," says Bell. Technically, Customs is supposed to detain all packages of prescription drugs
S E L F - R E G U L A T I O N
Certification Program For Online Pharmacies
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o improve the safety of buying prescription drugs over the Internet, the National Association of Boards of Pharmacy (NABP) initiated a program to certify online pharmacies. The voluntary program, called Verified Internet Pharmacy Practice Site (VIPPS), was introduced in 1999. So far, 13 online pharmacies have been certified out of an estimated 300 to 400 sites that sell prescription drugs on the Internet. NABP certifies each participating online pharmacy by documenting licensure from the appropriate state boards of pharmacy, making sure the pharmacy meets 17 selected criteria, and reviewing the pharmacy's written policies and procedures with an on-site inspection team. Certified pharmacies display the VIPPS seal on their home pages. "The true heart of the VIPPS program is the review process and seal," explains NABP President Dyke F. Anderson.
"When visitors first arrive at a VlPPS-certified website, they can instantly access some very important information about how that online pharmacy dispenses medication, protects their privacy, and ensures the quality and safety of their products." The VIPPS criteria were developed in cooperation with the Food & Drug Administration, the American Association of Retired Persons, and the American Medical Association. The criteria include the method of verifying the patient's or caregiver's identity; communication with consulting physicians, patients, or caregivers; the steps taken to ensure confidentiality; the method of dispensing medications; and methods for securing and tracking medications when shipped to the patient. Certified online pharmacies are reviewed annually to ensOre that they continue to meet the criteria.
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for FDA inspection. But neither Customs nor FDA has sufficient staff to carry out this requirement. FDA is now trying to devise a more practical approach. "Cus-
toms has been deluged with prescription drugs coming in from overseas," says Bell. "It is a major challenge for us to deal with this huge increase in volume."
Another problem is that not all 14 international mail facilities use the same criteria when they decide whether to let packages through, detain them for FDA
D E T E R R E N C E
sell in the other 49 states. Under this legislation, a domestic illegal seller that is put out of business in one state would be out of business in all states. To combat foreign-based rogue Internet sites, the legislation gave the Department of Justice the ability to stop illegal foreign operators from collecting credit card payments from U.S. customers. Finally, the legislation also required the secretary of the Department of Health & Human Services to educate the public about the dangers of buying medications online and about effective public- and private-sector consumer protections. The bills were supported by the National Association of Attorneys General, the American Pharmaceutical Association, the American Society of Health-System Pharmacists, and the online pharmacy Drugstore.com.
Internet Pharmacy Legislation
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ast fall, identical bills were introduced in the House and Senate to give the government more power to combat Internet pharmacies that sell drugs without valid prescriptions. The House (H.R. 5476) and Senate (S. 3208) bills, each titled "Internet Prescription Drug Consumer Protection Act of 2000," had significant bipartisan support, but no action was taken on them, and they have not been reintroduced this year. The Senate bill was sponsored by Sens. James M. Jeffords (l-Vt.), Edward M. Kennedy (D-Mass.), and Christopher J. Dodd (D-Conn.), and the House bill by former Reps. Thomas J. Bliley (R-Va.) and RonKlink(D-Pa.). The intent of the bills was to give states
additional enforcement tools to take action against domestic Internet sites that unlawfully sell pharmaceuticals and to give federal agencies the means to put illegal foreign sellers out of business. There were four primary provisions. First, Internet sellers of prescription drugs would have to disclose on their websites and to the appropriate state licensing board their street addresses, telephone numbers, and states where they are licensed to sell their products. Second, the bills authorized a state to go to federal court for a nationwide injunction against an unlawful Internet seller. Currently, a state only can stop an illegal website operator from selling drugs to citizens in its state, but that operator is free to
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inspection, turn them over to DEA, or return them to the sender. In addition, not all the mail centers have X-ray equipment, so some have more trouble than others detecting prescription drug shipments. FDA is also bringing more judicial actions against rogue websites based in the U.S. To date, it has made about 88 arrests and obtained 44 convictions, says McGinnis. However, the agency is having a great deal of trouble going after foreign sites. "We have to rely on an FDA counterpart in a foreign country to enforce whatever laws that foreign country has," McGinnis says. "Some of the countries have very good regulatory authority and others do not." In some cases, sending a "cyber letter" to a foreign site is effective, McGinnis says. "What we do is send an electronic message to the Web address, telling them they are doing something illegal." About a third of the cyber letters elicit a reply The sites answer that they didn't know they were breaking U.S. law and promise to cease and desist, he says. "When the cyber letter is not answered, we send letters to the foreign government counterpart and ask Customs
to put these firms on import alert. Customs then specifically looks for anything coming into the country from these particular pharmacies," he explains. However, Customs finds it nearly impossible to look for packages from specific pharmacies. The drugs are usually shipped in unmarked envelopes with phony return addresses, Bell says. FDA's efforts have resulted in a drastic decrease in drug sales from US.-based rogue sites, McGinnis claims. But most other experts do not agree. They say that such sales have increased or remained steady at best. THE NEW CYBERSMUGGLING Center established by the Customs Service last fall is aiding efforts to put foreign-based Internet pharmacies out of business, Bell says. The center searches the Web to identify foreign-based targets marketing prohibited drugs to U.S. consumers. "It conducts undercover purchases and uses other techniques unique to Internet investigations to identify locations, individuals, and businesses utilizing Internet websites or e-mail to sell prohibited drugs," he explains.
One website Customs managed to shut down was called Dr. Tonic /Vitality Health. It consisted of a decrepit warehouse in Thailand with kids inside stuffing envelopes full of drugs, Bell says. Many of the customers who had purchased drugs from Dr. Tonic were from the U.S. The Pharmaceutical Research & Manufacturers Association has not lobbied for any of the bills that aim to control rogue pharmacies, says Mark Grayson, a spokesman for the association. But the International Federation of Pharmaceutical Manufacturers Associations has been dealing with the issue for some time. It has set up a task force that has held several meetings to try to figure out a way to put a stop to rogue online pharmacies. Although new legislation may not be introduced this year, most experts in the area say that rogue pharmacies need to be dealt with eventually The injury they cause is insidiously quiet and hard to measure— death or sickness from unanticipated drug interactions and needless suffering or fatalities from substandard or counterfeit products —and may never attract a great deal of media attention. But it is no less real. •
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