• Amanda B. Westphal, Snake Oil Sales via the World Wide Web (2004).
• 151 Cong. Rec. S1531-35 (daily ed. Feb. 16, 2005) (statements of Sen. Coleman & Sen. Feinstein)
• Linda C. Fentiman, Internet Pharmacies and the Need for  New Federalism: Protecting Consumers While Increasing Access to Prescription Drugs, 56 Rutgers L. Rev. 119, 126-29 (2003).
• Kristin Yoo, Self-Prescribing Medication: Regulating Prescription Drug Sales on the Internet, 20 J. Marshall J. Computer & Info. L. 57, 63-66 (2001).

• Reduced Costs to Consumers
• Americans are increasingly turning to the Internet for access to affordable drugs.  In 2003, consumer spending on drugs procured over the internet exceeded $3.2 billion
• The cost of health care is skyrocketing, and the increases do not necessarily translate into higher quality care.  The average American family (those that are lucky enough to be able to afford health insurance at all) spends approximately $9,000 per year in health insurance premiums, and one source estimates that forty cents on every dollar spent in health care is used to pay administrative, transactional or clinical costs.  Allowing patients to use cybermedicine and purchase pharmaceuticals online can reduce the amount consumers pay overall.
  
• Purchasing pharmaceuticals over the Internet allows consumers to decrease costs by bypassing intermediary mark-ups
• Online drug sales promote price competition among licensed prescription drug sellers
  

• Convenience
• Increased access to prescription and non-prescription drugs for the elderly, disabled or otherwise homebound (for whom a trip to the pharmacy would be difficult), as well as for those who do not live close to a traditional pharmacy
• Convenience of shopping 24 hours a day
• Immediate access to needed drugs, which may be critical in this age of managed care, when a patient might have to wait days or even weeks to see a physician for nonemergency purposes.
  

• Privacy
• Consumers can protect their medical privacy, including avoiding the embarassment of discussing their medical conditions and purchasing drugs in a public place (note, however, consumers may not be assured absolute privacy online, and may inadvertently disclose personal and medical information to third parties)

• Reduction in Risk of Prescription Errors (as compared with handwritten prescriptions)
  

• Increased Access to Information
• Internet pharmacies are better able to immediately provide or direct customers to extensive information on pharmaceutical use and related topics (of course a consumer does not need to purchase drugs online to take advantage of the Internet's wealth of information)
• According to one study, conducting research regarding health concerns is the sixth most common reason people use the Internet.
  

• Risk of Receiving Counterfeit or Otherwise Worthless Pharmaceuticals (Fraud)
  
• Some Internet pharmacies dispense expired, subpotent, superpotent, contaminated or counterfeit drugs. This can result in overdose or other adverse health effects. Even those drugs that are "fake" but otherwise harmless can cause indirect harm to patients who need the genuine drug to treat a condition.  Along the same lines, at least one person has been convicted for selling fake HIV test kits on the Internet.
  
• According to the FDA, this is a particular concern with foreign Internet pharmacies, which may be located in countries with less rigorous supervision of the drug manufacturing and dispensing process.  Further, the United States Customs Service and the Drug Enforcement Agency do not have the resources to intercept, inspect and seize all illegally imported drugs.

• Risk of Faulty Self-Prescribing
• Self prescribing medication based on advertisements and related impersonal information sources, without ever consulting a physician in person, can increase a patient's likelihood of suffering an adverse effect.  There have been multiple cases of people dying from drugs purchased online.
  
• For example, a 52 year old man with a history of chest pain and family history of heart disease, which are contraindications to using Viagra, died of a heart attack after purchasing Viagra from an Internet pharmacy which only required completing an online questionnaire.
  
• A healthy 17 year old boy overdosed on a combination of hydrocodone, morphine, Valium and Oxazepam, for which he was able to obtain an online prescription from a doctor in Texas without a medical exam.
• Requiring a face to face physician visit is more likely to prevent patients with anorexia nervosa or other eating disorders from procuring prescriptions for diet drugs.
  

• Risk of Deliberate Misuse
• Consumers may purchase drugs that can be used to harm others. For example, the date rape drug GHB is an unapproved drug that has been sold online illegally.

• Risk of Misleading Consumers
• Web sites can be designed to make illegal or fraudulent businesses appear to be legitimate health care providers
  

• Accountability
• Because some Internet pharmacy sites, especially "rogue" sites, can disappear and pop up later in a different place, consumers and regulators may be unable to trace the faulty or misprescribed drug back to its source

• Exploiting fears
• Internet pharmacies are poised to cash in by exploiting public fears, often at the expense of the public health.  For example, Internet pharmacies were key players in the Cipro sales boom during the 2001 Anthrax scare, as well as in the 2004 flu vaccine price gouging.

• Click here  for a list of risks specific to buying pharmaceuticals from non-United States-based websites.
  

• 151 Cong. Rec. S1531-35 (daily ed. Feb. 16, 2005) (statements of Sen. Coleman & Sen. Feinstein).
• Internet Pharmacy Consumer Safeguards, Hearing before the House Comm. on Gov't Reform, 108th Cong. (2003) (statement of William K. Hubbard, Associate Commissioner for Policy, Planning and Legislation, FDA).
• John Henkel, Buying Drugs Online: It's Convenient and Private, but Beware of "Rogue" Sites, FDA Consumer, Jan.-Feb., 2000.
• Linda C. Fentiman, Internet Pharmacies and the Need for  New Federalism: Protecting Consumers While Increasing Access to Prescription Drugs, 56 Rutgers L. Rev. 119, 129-32 (2003).
• Kerry Toth Rost, Policing the "Wild West" World of Internet Pharmacies, 76 U. Chi.-Kent L. Rev. 1333, 1337-39 (2000).
  
• John Michael Ward, Online Pharmaceutical Regulation: An Avenue to a Safer World, 24 J. Legal Med. 77 (2003).
• Amanda B. Westphal, Snake Oil Sales via the World Wide Web (2004).
• Kristin Yoo, Self-Prescribing Medication: Regulating Prescription Drug Sales on the Internet, 20 J. Marshall J. Computer & Info. L. 57, 61-63 (2001).
• FDA, FAQs About Internet Pharmaceutical Sales.
  

• Kerry Toth Rost, Policing the "Wild West" World of Internet Pharmacies, 76 U. Chi.-Kent L. Rev. 1333, 1344-45 (2000).
• Linda C. Fentiman, Internet Pharmacies and the Need for  New Federalism: Protecting Consumers While Increasing Access to Prescription Drugs, 56 Rutgers L. Rev. 119 (2003).

• Many states are developing legislation to regulate online pharmaceutical sales through their traditional licensing authority.  
• A state may require an online pharmacy to obtain a license both in the state where it is located and also in the state where it attempts to sell pharmaceuticals.
  
•  A state may require an online pharmacy to disclose certain organizational information such as the names of principal officers within the company.
  

• Online pharmacies pose some nontraditional challenges for licensing boards.  
• Prior to online pharmacies there was little reason to worry about patients not receiving in person care, but now state lawmakers are face with the challenge of ensuring that virtual pharmacies do not threaten the vital aspects of the doctor patient relationship.

Illinois

Requires internet pharmacies to register with the state of Illinois, requires that the internet pharmacy be licensed in the state where it is located, requiring that the pharmacy keep records of drugs sold to Illinois residents, requiring the pharmacy to maintain a toll free number available to Illinois residents.
225 Ill. Comp. Stat. 85/16a. 

Nevada

Requires Internet pharmacies to be licensed in Nevada and in the states or countries where the pharmacy’s dispensing facilities are located.  Nevada also requires that practitioners examine patients six months prior to issuing prescriptions.  Nev. Rev. Stat. 639.2328.

Indiana

Requires Internet pharmacies to be licensed in the state in which they are domiciled. 
Ind. Code Ann. § 25-26-18-2.

Recently Proposed State Legislation

California

Hawaii

House Bill 1921 was introduced and died during the 2004 session.  The bill would direct the governor and agencies to develop, operate, and maintain a website to assist Hawaii residents in purchasing prescription drugs from Canada.

Indiana

Senate Bill 237 was introduced but failed to pass, during the 2004 session.  The bill would allow the designation of a mail order or an Internet-based pharmacy to provide prescription drugs under Medicaid or other health plans and would prohibit a denial of coverage for a covered prescription drug solely because the prescription drug was obtained from a pharmacy other than a designated mail order or Internet-based pharmacy.

Kentucky

Senate Bill 180 was introduced during the 2004 session but never made it out of committee.  The bill would define "counterfeit prescription drug" and make it illegal to sell, possess, distribute or facilitate distribution of them.  A first time violation of the statute would result in a $2,000 fine and a second time violation would result in a $50,000 fine and the revocation of any business  or professional license issued by the Commonwealth of Kentucky.

Massachusetts

Michigan

House Bill 5436 was introduced but failed to pass during the 2004 session.  The bill would regulate mail order and Internet pharmacies, requiring that they be licensed by Michigan. An out-of-state mail-order pharmacy would have to be licensed, certified, or registered to operate in the state in which it was domiciled.

Minnesota

Nevada

The Governor signed Senate Bill 337 on May 15, 2003.  The bill prohibits certain acts relating to filling or refilling a prescription through the Internet.  "A person who is located within or outside this state shall not, via the Internet, fill or refill a prescription drug if: (a) The person has reasonable cause to believe that the prescription is being filled or refilled for a person in this state; and (b) The prescription drug has not been lawfully imported into the United States.”  Violation of the statute carries a penalty of imprisonment for 3 to 15 years. 

New Jersey

Tennessee

Senate Resolution 158 was introduced but failed to pass during the 2004 session.  The non-binding Senate Resolution would urge the United States Secretary of Health and Human Services to "take necessary steps to stop sale and importation of prescription drugs" over the Internet.

For a summary of the States' legislative actions and policy clarifications, and surveys of state pharmacy and medical boards of October 2000, see Appendix II of the Government Accounting Office's publication,  Internet Pharmacies:  Adding Disclosure Requirements Would Aid State and Federal Oversight.

Back to top.

COORDINATION & CONFLICT BETWEEN STATE AND FEDERAL LAW

Coordination:

• The FDA, as the lead federal agency working in this arena, has coordinated extensively with the states.
  
• "Working closely with the states is essential to effectively regulate the sale of drugs, as well as the sale of prescription drugs without a valid prescription over the Internet. FDA has established partnership agreements with several state bodies, including the National Association of Boards of Pharmacies and the Federation of State Medical Boards, to coordinate federal and state activities aimed at questionable practices associated with the selling adn prescribing of prescription drugs over the Internet....FDA determines when and with whom to engage in joint enforcement activities based on the type and severity of of conduct identified through various means, including Internet monitoring." Internet Pharmacy Consumer Safeguards, Hearing before the House Comm. on Gov't Reform, 108th Cong. (2003) (statement of William K. Hubbard, Associate Commissioner for Policy, Planning and Legislation, FDA), at 7
  

• Some states, responding to concerns about rising and often prohibitive drug prices in the United States, have enacted laws permitting licensure of Canadian pharmacies to import prescription medications.  The FDA has responded with disapproval, noting almost certain violations of the FD&C Act. While legalizing importation of prescription drugs from Canada does not necessarily violate the FD&C Act, in practice federal regulations set out such specific requirements that any foreign importation is likely to be violative in at least one respect.
• Any state or private entity importing prescription drugs into the United States must "ensure, among other things, that it only imports FDA-approved drugs that comply with their FDA approvals in all respects, including manufacturing location, formulation, source and specifications of active ingredients, processing methods, manufacturing controls, container/closure system, and appearance." Letter from William K. Hubbard, FDA Associate Commissioner of Policy and Planning, to Patrick C. Lynch, Attorney General of Rhode Island (Jan. 28, 2005).
  

• Other states, including Minnesota and Wisconsin, offer residents guidance on purchasing pharmaceuticals from online Canadian pharmacies.  The FDA has specifically warned Minnesota that its program is "unsafe, unsound, and ill-considered." North Dakota Senator Byron Dorgan responded: "The American consumer is being cheated and the FDA is driving the getaway car."
  

• While not a regulatory body, the NABP assists state licensing boards in "developing, implementing, and enforcing uniform standards to protect the Public Health." NAPB includes pharmacy boards from the 50 states, the District of Columbia, and three U.S. territories.
• VIPPS, established by the NABP in 1999, is a voluntary program for which Internet pharmacies may apply. In order to qualify for VIPPS certification, an Internet pharmacy must demonstrate compliance with the laws of its home state, as well as those fo each state to which it sells pharmaceuticals. Certified pharmacies must also comply with VIPPS-mandated criteria including patients' right to privacy and authentication adn security of prescription orders.
  
• The FDA recommends that consumers check to see if sites are VIPPS-certified
  

• "Buying Medicines and Medical Products Online"
  
• Provides resources to consumers on evaluating Internet-based pharmacies and medical websites.
  
• Provides information about FDA enforcement actions against illegitimate pharmacy sites
  

• DEA's publication, "A Pharmacist's Guide to Prescription Fraud"
• Provides pharmacists with resources to help prevent drug abuse and diversion problems, especially in regard to controlled substances
• Outlines pharmacists' responsibilities, types of fraudulent prescriptions, characteristics of forged prescriptions and prevention techniques for pharmacies
  

• Internet Health Care Coalition created an International Code of Ethics for healthcare-related websites. The Code of Ethics gives practical guidance for incorporating ethical principles into websites.
  

• Developed a Code of Conduct for Internet healthcare sites, focusing on teh reliability and credibility of dispersed information