1. Online Pharmacies David Baumer Fall, 2006

2. Online Drug Distribution (1) The Internet allows people to self-medicate Online consumer sales of prescription drugs are in the billions –Many online sales are entirely legal, but many are not Websites sell drugs that are approved by the FDA Websites sell drugs to people who do not have prescriptions There is evidence that many drugs sold by websites are counterfeit –Many websites that sell drugs are not based in the U.S. Foreign websites sell unapproved drugs that are often improperly packaged and stored

3. Online Drug Distribution Drug websites offer –Some drugs at reduced prices and –Avoid embarrassment for “lifestyle” drugs Three types of drug pharmacies –Type I websites that sell drugs but customers must deliver prescriptions to the pharmacist Many Type I websites comply with all federal and state laws Similar to a mail order pharmacy

4. Online Drug Distribution Type II websites offer diagnosis as well as prescription for medication –Done without a physical examination –Many of these sites sell Viagra, Propecia, and Prozac –Prescriptions are the result of an online survey FDA contends that prescriptions in which the patient does not have a face to face interaction with a health care professional poses serious health risks. Virtually everyone filling out the online survey is granted a prescription –In many cases, online prescriptions are a charade –There is no background checks of the online answers

5. Online Drug Distribution Type III websites are called “rogue” websites –Allows purchases of drugs online without a prescription Rogue websites operate under conditions of caveat emptor Type III websites make use of disclaimers to shield the from liability for harmful drug interactions

6. Online Drug Distribution Although the Internet is an interstate and international medium states continue to play a key role in drug distribution –In general, state laws require that prescription drugs only be sold to in-state residents by A physician licensed in that state and through A pharmacist licensed in that state Doctors cannot prescribe drugs unless they have a bona fide doctor-patient relationship –Most states specify that a doctor-patient relationship means a physical examination or at least a face to face encounter

7. Online Drug Distribution States cannot agree on what constitutes a valid doctor-patient relationship –Call-in prescriptions have been routine for years –Telemedicine prescriptions are also common in some states –State laws vary on this point Two federations have been active in monitoring online pharmacies –Federation of State Medical Boards (FSMB) and –National Association of Boards of Pharmacy (NABP)

8. Medical Boards The FSMB has issued Model Guidelines For Appropriate Use of the Internet in Medical Practice –According to the FSMB, it is unprofessional to prescribe medicine without An adequate medical history and A physical examination Some exceptions are allowed when there is consultation with another doctor or there is an emergency FSMB recommends sanctions against physicians who issue prescriptions based on an online questionnaire

9. Medical Boards The NABP takes the position that online pharmacies that use online questionnaires are acting illegally The NABP has promoted VIPPS (Verification of Internet Pharmacy Practice Sites) to signal what they believe are legal online pharmacies –Qualifying for VIPPS requires full licensing in each state where sales are made To date there are 12 VIPPS certified online pharmacies

10. Medical Boards The American Medical Association also contends that offering prescriptions on the basis of online questionnaires is inappropriate –AMA contends that to write a prescription, the physician must have a prior relationship with the patient

11. State Regulation of Online Pharmacies Most states require a physical examination before a prescription –The prescription can only be filled by a pharmacist licensed in that state Other states only require the pharmacist to be licensed in some state –Over 40 states have passed laws requiring out of state pharmacies, including online pharmacies, to receive a permit from the state board of pharmacy –A number of states have taken legal actions against Internet pharmacies In some states the disciplinary actions have been against pharmacists, while in others, they have gone after doctors Some states have instituted civil actions against online pharmacies –In most cases state civil actions are designed to obtain injunctions and consent decrees

12. Federal Actions FDA has authority under the FDCA to regulate prescriptions drugs –Without a valid prescription, the drug is considered misbranded And thus a violation of the FDCA –In 1999 the FDA adopted the Internet Drug Sales Action Plan (IDSAP) The FDA has partnered with other fed. and state agencies Partnerships were also created with NABP, FSMB, and the National Association of Attorneys General The FDA monitors the Internet for suspect websites

13. Federal Actions The Federal Trade Commission (FTC) is empowered to protect consumers from –Unfair and deceptive trade practices –The FTC can intervene when false claims are made at drug websites The Drug Enforcement Administration (DEA) enforces federal drug laws –If the drug is also a controlled substance, DEA has authority to intervene –DEA has prosecuted owners of the websites, doctors affiliated with the website and pharmacists –For controlled substances, the DEA insists on a valid prescription and registration of foreign importers

14. Canadian Reimportation The Canadian govt. lowers the prices of U.S. drugs by negotiations with the drug companies –These lower prices are attractive to U.S. citizens who can access “Canadian” websites –Politicians are under pressure from seniors to lower prices for drugs –U.S. pharmaceutical companies have threatened to cut off supplies to Canadian outlets that resell the drugs to U.S. citizens The threat of a cut-off has pushed the Canadian government take action against some reimportation websites

15. Reimportation There is substantial evidence that some of the Canadian websites –Are not reimporting U.S. drugs, but rather –Obtaining generic versions of the U.S. drugs from other countries –There are also substantial safety concerns about imported drugs

16. Congressional Actions Among the proposals was the –Internet Pharmacy Consumer Protection Act Establishes minimum standards for websites –Websites must name the website pharmacist and what states the pharmacist is licensed to practice –For websites that offer online prescriptions, the website has to list the doctor and the states in which he or she is licensed to practice –This act was not enacted

17. Congressional Actions Safe Import Act (not enacted) –Online pharmacies would have to register with the Sec. of HHS. Only properly registered online pharmacies would be allowed to sell medications directly to U.S. consumers Prescriptions would have to be valid in a State and cosigned by a prescribing physician in Canada Under the Safe Import act a website is guilty of distributing illegal drugs if it is sells drugs and is not certified Websites would have to pay a $5,000 registration fee –Must comply with all federal and state laws regarding pharmcies

18. Action by the Federal Govt. The task of regulating online pharmacies –At the present is beyond the capabilities of govt.s Proposals from the 109 th Congress –In 2005 the Pharmaceutical Market Access Act was introduced The bill would allow U.S. citizens to purchase FDA-approved drugs that are made in 25 industrialized countries Exporters must make their facilities available for inspection by the FDA

19. Obstacles to the Regulation of Internet Pharmacies Commerce Clause –Illustrates the limits of state regulation Non-discriminatory State laws that interfere with interstate and foreign commerce could struck down as being unconstitutional So far no State drug law has been declared unconstitutional Jurisdiction –Foreign websites are not subject to the jurisdiction of U.S. courts –For websites within the U.S. but not in-state, these websites are subject to jurisdiction of the state courts if the minimum contacts test is satisfied

20. Some Recommended Changes Federal initiated uniformity –Online pharmacies must comply with the state laws in which they make sales This proposal would make all drug websites VIPPS compliant or outlaws –Foreign websites Difficult to enforce U.S. law against websites that are located in sovereign countries –Physical examination of patients required