HHS, DOJ, and DHS provided technical comments on a draft of this report, which GAO incorporated as appropriate. GAO-13-560, Jul 8, 2013

Why GAO Did This Study

The Internet offers consumers a convenient method for purchasing drugs that is sometimes cheaper than buying from traditional brick-and-mortar pharmacies. According to a recent FDA survey, nearly 1 in 4 adult US Internet consumers have purchased prescription drugs online. However, many Internet pharmacies are fraudulent enterprises that offer prescription drugs without a prescription and are not appropriately licensed. These rogue Internet pharmacies may sell drugs that are expired, improperly labeled, or are counterfeits of other drugs. A number of federal and state agencies share responsibility for administering and enforcing laws related to Internet pharmacies, including state boards of pharmacy, FDA, DOJ, CBP, and ICE.

The Food and Drug Administration Safety and Innovation Act directed GAO to report on problems with Internet pharmacies. This report identifies (1) how rogue sites violate federal and state laws, (2) challenges federal agencies face in investigating and prosecuting operators, (3) efforts to combat rogue Internet pharmacies, and (4) efforts to educate consumers about the risks of purchasing prescription drugs online. To conduct this work, GAO interviewed officials from FDA, DOJ, CBP, ICE, and other federal agencies, reviewed federal laws and regulations, and examined agency data and documents. GAO also interviewed officials from five state boards of pharmacy with varied approaches to regulating Internet pharmacies, and stakeholders including NABP, drug manufacturers, and companies that provide services to Internet businesses, such as payment processors.

For more information, contact Marcia Crosse at (202) 512-7114 or CrosseM@gao.gov. Full report (55 pages): http://www.gao.gov/assets/660/655751.pdf

Editor's Note:The FDA offers these tips and guidelines:

What Consumers Can Do

With hundreds of drug-dispensing Web sites in business, how can consumers tell which sites are legitimate ones, especially when it is very easy to set up a site that is very professional-looking and promises deep discounts or a minimum of hassles?

"Consumers need to be cautious," says Jeffrey Shuren, M.D., medical officer in the FDA's Office of Policy, Planning and Legislation. "You should use the same kind of common sense you use when buying from any business. You look for a reputable dealer. You check the place out."

The FDA offers these tips to consumers who buy health products online:

• Check with the National Association of Boards of Pharmacy to determine if the site is a licensed pharmacy in good standing (visit the Web site at www.nabp.net, or call 847-698-6227).
• Don't buy from sites that offer to prescribe a prescription drug for the first time without a physical exam, sell a prescription drug without a prescription, or sell drugs not approved by the FDA.
• Use sites that provide convenient access to a licensed pharmacist who can answer your questions.
• Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone number to contact if there's a problem.
• Beware of sites that advertise a "new cure" for a serious disorder or a quick cure-all for a wide range of ailments.
• Be careful of sites that use impressive-sounding terminology to disguise a lack of good science or those that claim the government, the medical profession, or research scientists have conspired to suppress a product.
• Steer clear of sites that include undocumented case histories claiming "amazing" medical results.
• Talk to your health-care practitioner before using any medication for the first time.

If you suspect a site is illegal, you can report it to the FDA by using the online reporting form on the agency's Web site.

--J.H.

Publication No. (FDA) 01-3235

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