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You have a stomach cramp. You want relief. You go online. You come to an emedicine website filled with marvelous and generous information. After a bit you decide that you must indeed have an ulcer and you are sure that this site has just the thing for you. You engage an interactive questionnaire that produces a diagnosis, and, based on this online diagnosis, the website service writes you a prescription and places the medicine in the mail.

Question: is this practice akin to snake oil vendors of the Wild West, willing to sell you whatever they can convince will cure you? Is this a way to bypass federal prescription drug laws or bypassing high domestic perscription prices? No doctor has ever seen you in person. What if you are a native American on a reservation in North Dakota where there is not a doctor within 200 miles? Is this part of the Internet's promise of the death of distance, bring telemedicine to reaches otherwise inaccessible to medical professionals?

Prescription drug sales, online or off, are regulated by the Food and Drug Administration pursuant to the Food, Drug, and Cosmetic Act. [21 U.S.C. § 353] Pursuant to the FDCA,

  • Drugs classified as prescription drugs may be distributed only pursuant to a valid prescription of a licensed practitioner.
  • Prescription drugs dispensed without a prescription are "misbranded" in violation of the FDCA. [21 U.S.C. § 353(b)]
  • The determination of whether a purely online diagnosis can produce a valid prescription is largely determined by state law.
  • Kansas, Maryland, Washington have taken action against websites that have written prescriptions based solely on online diagnosis, and the State Federation of Medical Boards has concluded that online diagnosis cannot produce valid prescriptions. The Department of Justice does not appear to be over enamored with online prescriptions. [Posner] [Fong]

    But perhaps the miracle cure to your ulcer does not require a prescription. Perhaps you have found a bottle of marvelous stuff at And perhaps, much to your surprise, the stuff does not work. Here the Federal Trade Commission once again steps in with its fraud and deceptive practice authority. The FTC brings enforcement actions against online pharmacies and stores that make false or misleading claims about the wonders of their products or services. FTC activity in this area falls under their project Operation Cure.all.

    The FTC provides advice for business engaged in online medicine. Some of this information is specific to the health industry such as guidelines for dietary supplements and some of this information includes the general guidance for all merchants doing business online. See Ecommerce.


    Potentially Applicable Federal Law

    Distribution of prescription drugs without a valid prescription

    Food, Drug, and Cosmetic Act,
    21 U.S.C. § 353

    Distribution of controlled substances without a valid prescription.

    Controlled Substances Act,
    21 U.S.C. §§ 822, 829 & 841

    Unfair or deceptive marketing of prescription drugs

    Federal Trade Commission Act,
    15 U.S.C. § 45

    Internet Sales of Date Rape Drugs 21 USC § 841

    Violations of these laws can fall under the jurisdiction of the Department of Justice, the US Attorney's Office, the FBI, the Food and Drug Administration, The Drug Enforcement Administration, and the Federal Trade Commission.

    Broadband Plan Recommendations

  • Unlock the value of data
  • The Office of the National Coordinator for Health Information Technology (ONC) should establish common standards and protocols for sharing administrative, research and clinical data, and provide incentives for their use.
  • Congress should consider providing consumers access to- and control over-all their digital health care data in machine-readable formats in a timely manner and at a reasonable cost.
  • Ensure sufficient connectivity for health care delivery locations
  • The FCC should replace the existing Internet Access Fund with a Health Care Broadband Access Fund.
  • The FCC should establish a Health Care Broadband Infrastructure Fund to subsidize network deployment to health care delivery locations where existing networks are insufficient.
  • The FCC should authorize participation in the Health Care Broadband Funds by long-term care facilities, offsite administrative offices, data centers and other similar locations. Congress should consider providing support for for-profit institutions that serve particularly vulnerable populations.
  • To protect against waste, fraud and abuse in the Rural Health Care Program, the FCC should require participating institutions to meet outcomes-based performance measures to qualify for Universal Service Fund (USF) subsidies, such as HHS's meaningful use criteria.
  • Congress should consider authorizing an incremental sum (up to $29 million per year) for the Indian Health Service (IHS) for the purpose of upgrading its broadband service to meet connectivity requirements.
  • The FCC should periodically publish a Health Care Broadband Status Report.
  • Laws

  • EMail the FDA concerning illegal online sales
  • FDA Reporting Unlawful Sales of Medical Products on the Internet
  • Kent Aoki Lee Charged by Federal Grand Jury with Wire Fraud, Trademark Violations, and Selling Viagra over the Internet Without a Prescription (December 9, 1999) 
  • "On March 27, 2000, John T. Bentivoglio, Special Counsel for Health Care Fraud and Chief Privacy Officer at the U.S. Department of Justice, gave remarks on the prosecution of health care fraud and the protection of health care privacy on the Internet.  His speech focused on the  Federal government’s fraud, consumer protection, and privacy protection efforts as they relate to the Internet healthcare industry. Remarks of John T. Bentivoglio, Special Counsel for Health Care Fraud and Chief Privacy Officer, U.S. Department of Justice, at the Symposium on Healthcare Internet and E-Commerce: Legal, Regulatory and Ethical Issues (March 27, 2000)"
  • John Henkel, Buying Drugs Online: It’s Convenient and Private, but Beware of Rogue Sites, 34 FDA CONSUMER 24, 27 (Jan.-Feb. 2000)
  • HR 4472 Adam Walsh Child Protection and Safety Act of 2006
  • Internet Sale Date Rape Drug illegal 21 USC § 841(g)
  • FDA Cyberletters
  • Concerns

    Consumer Information

    Federal Activity

    FTC Operation Cure.all

    "Looking to cure a serious ailment? Unfortunately, consumers spend millions of dollars every year on unproven - and often useless - health products and services. Health fraud trades on false hope. It promises quick cures for dozens of medical conditions - from arthritis and obesity to osteoporosis, cancer and AIDS.

    "Fraudulently marketed health products can keep people from the medical treatment they need, and some can cause serious harm.

    "The Federal Trade Commission is targeting false and unsubstantiated health claims on the Internet through Operation Cure.All - a law enforcement and consumer education campaign. This website offers information for consumers on how to recognize health fraud, guidance for businesses on how to market health products and services truthfully, and information about the FTC's initiatives."  Operate Cure.all

     "Operate Cure.all," an initiative begun in 1997 in response to rising concerns about the proliferation of questionable marketing claims for health products on the Internet, is an integral part of the Commission's campaign against the fraudulent marketing of health-related products on the Internet. "Operation Cure.All" is an ongoing, coordinated law enforcement and consumer/business education initiative targeting deceptive and misleading Internet promotion of products and services that promise to cure or treat serious diseases or conditions such as cancer, HIV/AIDS, arthritis, diabetes, multiple sclerosis, and heart disease. The FTC works with numerous law enforcement partners including the FDA, Health Canada, the Competition Bureau of Industry Canada, Procuraduria Federal del Consumidor of Mexico, the Secretaria de Salud of Mexico, several state attorney general offices, and several state health departments as part of this initiative.

    As part of the agencies' effort to identify appropriate law enforcement targets, "Operation Cure.All" partners periodically conduct Internet surfs. To date, the FTC and its partners have conducted three international surfs, in 1997, 1998, and 2002, and a number of narrowly targeted surfs focused on specific types of diseases or products such as anthrax. Since June 1999, the FTC has filed 18 "Operation Cure.All" cases.

    "Like other health care promotions on the Internet," Director Beales testified, "the availability of prescription drugs via online pharmacies can offer benefits to consumers, including convenience and value. However, 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 by overseas pharmacies." -March 27, 2003 FTC Testifies on the Internet Sale of Prescription Drugs From Domestic Web Sites 

  • File Complaint
  • Consumer Information
  • Business Information
  • Press Room (includes enforcement actions)
  • FTC "Operation Cure.All" Wages New Battle in Ongoing War Against Internet Health Fraud
  • March 27, 2003 FTC Testifies on the Internet Sale of Prescription Drugs From Domestic Web Sites
  • July 24, 2002 Company Touting Unproven Cancer Treatment Agrees to Settle FTC Charges [TEXT]
  • November 7, 2001 Aggressive Law Enforcement, Consumer and Business Education Will Characterize FTC Efforts [TEXT]
  • September 10, 2001 FTC'S Beales Testifies on Campaign to Combat Health Fraud and the Elderly [TEXT]
  •  July 13, 2001 FTC Announces a Second Case Focusing on Safety Risks of Comfrey Products Promoted via Internet [TEXT]
  • July 6, 2001 Latest FTC Case in "Operation Cure.All" Focuses on Safety Risks of Comfrey Products Promoted Via Internet [TEXT]
  • June 14, 2001 "Operation Cure.All" Wages New Battle in Ongoing War Against Internet Health Fraud [TEXT]
  • June 29, 2000 "Operation Cure.all" Nets Shark Cartilage Promoters: Two Companies Charged with Making False And Unsubstantiated Claims for Their Shark Cartilage And Skin Cream as Cancer Treatments [TEXT]
  • April 5, 2000 FTC Hits Internet Health Fraud in Continuation of Operation Cure.All: [TEXT]
  • Dec. 9, 1999 "Operation Cure.all" Targets Internet Health Fraud [TEXT]
  • November 10, 1998 Remedies Targeted in International Health Claim Surf Day [TEXT]
  • November 5, 1997 North American Health Claim Surf Day Targets Internet Ads [TEXT]
  • Screening Advertisements: A Guide for The Media [TEXT] [PDF]
  • Enforcement

  • Press Release FDA International Internet Drug Ring Shattered April 2005
  • Press Release, FTC, FTC Cracks down on Marketers of Bogus Bioterrorism Defense Products: Agency Tells Web Site Operators Get Off the Net or Face Prosecution (Nov. 19, 2001).
  • New Jersey Man Pleads Guilty to Selling Non-FDA Approved HIV Test Kits over the Internet (October 25, 2000)
  • Papers and Presenations




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