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Cybertelecom Federal Internet Law & Policy An Educational Project |
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E-Medicine | |
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- Ecommerce - Advertising - - Behavioral - Alcohol & Tobacco - Antitrust - Crypto - Delivery - DNS - E-Medicine - E Signatures - Fraud - Gambling - Intellectual Property - Online Investing - Privacy - Taxes - Statistics |
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 snakeoil.com. 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.
Issue |
Potentially Applicable Federal Law |
Distribution of prescription drugs without a valid prescription |
Food, Drug, and Cosmetic Act, |
Distribution of controlled substances without a valid prescription. |
Controlled Substances Act, |
Unfair or deceptive marketing of prescription drugs |
Federal Trade Commission Act, |
| 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
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- Create appropriate incentives for e-care utilization
- Congress and the Secretary of Health and Human Services (HHS) should consider developing a strategy that documents the proven value of e-care technologies, proposes reimbursement reforms that incent their meaningful use and charts a path for their widespread adoption.
- Modernize regulation to enable health IT adoption
- Congress, states and the Centers for Medicare & Medicaid Services (CMS) should consider reducing regulatory barriers that inhibit adoption of health IT solutions.
- The FCC and the Food and Drug Administration (FDA) should clarify regulatory requirements and the approval process for converged communications and health care devices.
- 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
- 21 U.S.C. § 353.
- 21 U.S.C. § 353(b).
- 21 USC § 841 Prohibition on Internet Sales of Date Rape Drugs (enacted as a part of the Adam Walsh Child Protection and Safety Act, Pub. L. 109-248)
- Illegal Online Medical Sales
- 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
- Testimony of Ethan M. Posner, Deputy Associate Attorney General, on Online Pharmaceutical Drug Sales before the Subcommittee on Oversight and Investigations of the House Committee on Commerce (May 25, 2000)
- Statement of Ivan Fong, Deputy Associate Attorney General, Before the Subcommittee on Oversight and Investigations of the House Committee on Commerce, Concerning the Sale of Prescription Drugs over the Internet (July 30, 1999
- FTC Testifies on the Internet Sale of Prescription Drugs From Domestic Web Sites, FTC 3/28/03
- Point, Click, Self-Medicate: A Review of Consumer Safeguards on Internet Pharmacy Sites: Hearing Before the House Comm. on Gov’t Reform, 108th Cong. 116 (2003)
- FDA Talk Paper, Fda Issues Cyber-Letters To Web Site Selling Unapproved Foreign Ciprofloxacin(Nov. 1, 2001).
- United States General Accounting Office, Internet Pharmacies: Adding Disclosure Requirements Would Aid State and Federal Oversight, GAO-01-69, 1, 3-4 (Oct. 2000)
- Statement of Ethan M. Posner, Deputy Associate Attorney General, U.S. Department of Justice, Before the Subcommittee on Oversight and Investigations, Committee on Commerce, U.S. House of Representatives (May 25, 2000) .
- Press Release, FDA, FDA Launches “Cyber” Letters Against Potentially Illegal, Foreign-Based Online Drug Sites (Feb. 2, 2000)
- Enforcing the Laws on Internet Pharmaceutical Sales: Where Are the Feds?: Hearing Before the Subcomm. on
Oversight and Investigations of the House Comm. on Commerce, 106th Cong. 23-29 (2000)- Press Release, FTC, Online Pharmacies Settle FTC Charges (July 12, 2000)
- E-DRUGS: Who Regulates Internet Pharmacies?: Hearing on Examining the Benefits and Risks of Pharmaceutical Sales Over the Internet, Focusing on Public Health Implications, Law Enforcement, and Regulatory Challenges Before the Senate Comm. on Health, Educ., Labor, and Pensions, 106th Cong. 11-14 (2000)
- Press release: NJ man admits distributing unapproved hiv home test kits Oct 25 2000
- FDA’S Counterfeit Drug Task Force Interim Report
- Statement if Ivan Fong, Deputy Attorney General, before the subcommittee on oversight and investigations july 30, 1999;
- NTIA, Telemedicine Report to Congress summarizes the work of the Joint Working Group on Telemedicine and details the legal, political and technical issues that face telemedicine expansion. (01-31-1997)
| "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 |
Enforcement
- DOJ DEA Report Suspicious Internet Pharmacies
- 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
- Linda C. Fentiman , Internet Pharmacies And The Need For A New Federalism : Protecting Consumers While Increasing Access To Prescription Drugs 120 Rutgers Law Review 123 (2004)
- Susannah Fox, Deborah Fallows, Internet Health Resources: Health searches and email have become more commonplace, but there is room for improvement in searches and overall Internet access, TPRC 9/13/03
- Lance J. Hoffman Making Every Vote Count: Security and Reliability of Computerized Vote-Counting Systems PDF
- Anya Kim, Marion Meissner, Jeff Collmann, Lance J. Hoffman Risk Analysis of a Telemedicine System This work is supported by U.S. Army grants (DAMD17-94-V-4015) and National Library of Medicine Contract N01-LM-6-3544. The content of this manuscript does not necessarily reflect the position or policy of the U.S. Government. 7/28/97 Presentation
- FDA: Buying Medical Devices Online
- Commission recommends Quality Criteria for Health Websites, eu 12/20/02
- Internet Prescribing: An Interim Report, AMA BD. OF TR. REP. 35-A-99 (1999)
Links
- HealthIT.gov Health information technology (health IT) makes it possible for health care providers to better manage patient care through secure use and sharing of health information. Health IT includes the use of electronic health records (EHRs) instead of paper medical records to maintain people's health information.
- Immigration and Customs: Cyber Crime Center: Cyber Crimes Section
- Healthfinder.gov
- Operate Cure.all
- U.S. FDA
- Verified Internet Pharmacy Practice Sites : Most Frequently Asked Questions
