Under the Federal Food, Drug, and Cosmetic Act (FDCA), FDA is  responsible for ensuring the safety, effectiveness, and quality of domestic  and imported prescription drugs that are marketed to U.S. consumers. CBP is responsible for enforcing laws prohibiting the illegal importation of  goods into the United States, including prescription drugs that have not  been approved by the FDA for the U.S. market, as well as those that are  counterfeit or misbranded. DOJ’s Civil and Criminal Divisions also  prosecute such cases, coordinating closely with U.S. As a result, they may be reluctant to report health problems that  they experience. Most Rogue Internet Pharmacies Operate from Abroad, and Many Illegally Ship Unapproved Drugs into the United States and Sell Drugs without Requiring Valid Prescriptions

Although the exact number of rogue Internet pharmacies is unknown,  most operate from abroad. Rogue Internet pharmacies also often sell drugs to consumers without a  prescription, in violation of FDCA and state requirements, or with a  prescription that does not satisfy FDCA and state requirements. Rogue Internet Pharmacies Violate a Variety of Other Federal and State Laws and Industry Standards

Rogue Internet pharmacies violate a variety of federal laws, including  those related to fraud, money laundering, and intellectual property rights,  according to officials from several federal agencies and stakeholders we  interviewed. According to officials from state boards of pharmacy we  interviewed, brick-and-mortar pharmacies have fulfilled online prescription  drug orders, including to residents of another state without obtaining a  nonresident pharmacy license in the state where those customers reside  or without ensuring the prescriptions are valid. The Complex and Global Nature of Rogue Internet Pharmacies Poses Substantial Challenges for Federal Investigators and Prosecutors

Rogue Internet pharmacies are often complex, global operations, and as  a result, federal agencies face substantial challenges investigating and  prosecuting their operators. Officials from federal agencies and  stakeholders we interviewed told us that piecing together these  operations can be difficult because rogue Internet pharmacies can be  composed of thousands of related websites. 1.) Federal Agencies Have Investigated and Prosecuted Rogue Internet Pharmacy Operators and Prevented Some Illegal Shipments

Despite facing substantial challenges, several federal agencies— including FDA, ICE, and USPIS—have investigated and prosecuted  rogue Internet pharmacy operators that have violated federal laws. Agency investigations have resulted in the conviction of  operators, fines, and asset seizures. For example, FDA and other federal agencies have  participated in Operation Pangea, an annual worldwide, week-long  initiative in which regulatory and law enforcement agencies from around  the world work together to combat rogue Internet pharmacies. Federal agencies responsible for preventing illegal prescription drug  imports have also interdicted rogue Internet pharmacy shipments. State boards of pharmacy focus on regulating licensed brick-and-mortar  pharmacies located within their state. CSIP has helped member companies that provide services to Internet  businesses—such as Internet registrars, search engines, and  payment processors—share information about rogue Internet  pharmacies, and encourages its members to block services to them.CSIP contracts with a third-party company that proactively searches  the Internet to identify rogue Internet pharmacies and disseminates  this information to its members. 4.) FDA and Stakeholders Have Taken Steps to Educate Consumers about the Risks of Purchasing Prescription Drugs from Internet Pharmacies, but Challenges Remain

FDA and stakeholders have taken steps to educate consumers about the  dangers of buying prescription drugs from rogue Internet pharmacies and  how to identify legitimate ones; however, these efforts face challenges. Some federal agencies and stakeholders have also taken steps to  educate consumers about the risks of purchasing prescription drugs  online and provide tools to help consumers identify legitimate and rogue  Internet pharmacies. NABP also warns consumers not to  buy from websites that are on its publicly available list of rogue Internet  pharmacies, and posts information on its website to educate consumers  about how to safely buy medicine online. Many rogue Internet pharmacies use  sophisticated marketing methods to appear professional and legitimate,  making it challenging for even well-informed consumers and health care  professionals to differentiate between legal and illegal Internet  pharmacies. Agency Comments

We provided a draft of this report for comment to HHS, DOJ, and DHS,  and we provided excerpts of this report for comment to USPIS and NSF. We received technical comments from HHS, DOJ, and DHS, which we  incorporated as appropriate. We are sending copies of this report to the Department of Commerce, the  Department of Health and Human Services, the Department of Homeland  Security, the Department of Justice, the Department of State, the Federal  Trade Commission, the Internal Revenue Service, the National Science  Foundation, the Office of Management and Budget, and the United States  Postal Inspection Service, as well as other interested parties. National Association of Boards of Pharmacy  22. Establishing a Safe Harbor for Companies That Provide Services to  Internet-Based Businesses.
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 U.S. 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.

What GAO Found

Rogue Internet pharmacies violate a variety of federal and state laws. Most operate from abroad, and many illegally ship prescription drugs into the United States that have not been approved by the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), that is responsible for ensuring the safety and effectiveness of prescription drugs. Many also illegally sell prescription drugs without a prescription that meets federal and state requirements. Rogue sites also often violate other laws, including those related to fraud, money laundering, and intellectual property rights.
Rogue Internet pharmacies are often complex, global operations, and federal agencies face substantial challenges investigating and prosecuting those involved. According to federal agency officials, piecing together rogue Internet pharmacy operations can be difficult because they may be composed of thousands of related websites, and operators take steps to disguise their identities. Officials also face challenges investigating and prosecuting operators because they are often located abroad. The Department of Justice (DOJ) may not prosecute such cases due to competing priorities, the complexity of these operations, and challenges related to bringing charges under some federal laws.
Despite these challenges, federal and state agencies as well as stakeholders have taken actions to combat rogue Internet pharmacies. Federal agencies have conducted investigations that have led to convictions, fines, and asset seizures from rogue Internet pharmacies as well as from companies that provide services to them. FDA and other federal agencies have also collaborated with law enforcement agencies around the world to disrupt rogue Internet pharmacy operations. The Department of Homeland Security's (DHS) U.S. Customs and Border Protection (CBP) and U.S. Immigration and Customs Enforcement (ICE), which are responsible for enforcing laws related to the importation of goods such as prescription drugs, have also worked with other agencies, including FDA, to interdict rogue Internet pharmacy shipments at the border. Given that most rogue Internet pharmacies operate from abroad, states have faced challenges combating them, and generally focus their oversight on licensed in-state entities that fulfill orders for rogue Internet pharmacies. Companies that provide services to Internet-based businesses, such as search engines and payment processors, have also taken action--primarily by blocking services to them.
FDA and others have taken steps to educate consumers about the dangers of buying prescription drugs from rogue Internet pharmacies. FDA recently launched a national campaign to raise public awareness about the risks of purchasing drugs online, and the National Association of Boards of Pharmacy (NABP) posts information on its website about how to safely purchase drugs online. However, rogue Internet pharmacies use sophisticated marketing methods to appear legitimate, making it hard for consumers to differentiate between legitimate and rogue sites.
HHS, DOJ, and DHS provided technical comments on a draft of this report, which GAO incorporated as appropriate.