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1. Why is FDA concerned about unlawful drug sales on the Internet?
2. Are there any benefits to purchasing approved drugs online?
3. How many web sites sell prescription drugs?
4. How many people have been harmed from drugs purchased over the Internet?
6. Why shouldn't the online pharmacy industry be self-regulated?
8. How many states have acted against web sites selling prescription drugs?
9. Who will FDA refer complaints to at the state level?
10. How will FDA integrate its efforts with the White House Electronic Commerce Working Group?
11. What are international organizations like WHO doing about Internet prescribing and dispensing?
12. Can an American patient get a medication not approved in the U.S. from a foreign dispenser?
13. Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.?
1. Why is FDA concerned about unlawful drug sales on the Internet?
Patients who buy prescription drugs from Websites operating outside the law are at increased risk of suffering life-threatening adverse events, such as side effects from inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and impure or unknown ingredients found in unapproved drugs.
The current system of federal and state safeguards for protecting patients from the use of inappropriate or unsafe drugs has generally served the country well. These laws require that certain drugs be dispensed only with a valid prescription because they are not safe for use without the supervision of a licensed health care practitioner. Generally, before the practitioner issues a prescription for a drug the patient has never taken before, he or she must first examine the patient to determine the appropriate treatment. Subsequently, the patient receives the drug from a registered pharmacist working in a licensed pharmacy that meets state practice standards.
The Internet makes it easy for unscrupulous people to sell drugs to patients without these safeguards in place. A Website may appear to be associated with a legitimate pharmacy when in fact it is not. Websites that sell prescription drugs without a valid prescription deny consumers the protection provided by an examination conducted by a licensed practitioner.
2. Are there any benefits to purchasing approved drugs online?
Yes. Legitimate pharmacy sites on the Internet provide consumers with a convenient, private, way to obtain needed medications, sometimes at more affordable prices. The elderly and persons in remote areas can avoid the inconvenience of traveling to a store to purchase medications. Many reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their home. Moreover, Internet pharmacies can provide customers with written product information and references to other sources of information like the traditional storefront pharmacy. Finally, the increasing use of computer technology to transmit prescriptions from doctors to pharmacies is likely to reduce prescription errors.
3. How many web sites sell prescription drugs?
The National Association of Boards of Pharmacy has identified approximately 200 domestic web sites that dispense prescription drugs but do not offer an online prescribing service. According to a recent Chicago Tribune article cited by the American Medical Association, there are at least 400 web sites that both dispense and offer a prescribing service -- half of these sites are located in foreign countries. Some have estimated that the number of Websites selling prescription drugs may now be closer to 1,000. The number of Websites, however, fluctuates from day to day, and seems to be growing.
4. How many people have been harmed from drugs purchased over the Internet?
It is impossible to accurately quantify adverse event rates because FDA's postmarketing surveillance system receives reports on only a relatively small percentage of all adverse events caused by drugs. However, as a result of postmarketing surveillance data collected by FDA, we know that the sale of unapproved drugs and the illegal sale of approved drugs over the Internet poses a serious public health risk. We know, for example, of many adverse events resulting from the use of the drug GBL and the date rape drug GHB, which are unapproved drugs sold illegally
over the Internet. FDA learned recently of a person who was harmed by the use of Viagra purchased from a Website without an examination by a healthcare professional. Unfortunately, the man had a family history of heart disease and died after taking the drug.
We also know of cases where people choose the Internet for treatment to avoid consulting a health care professional. These consumers, however, run the risk of purchasing inappropriate drugs or unknowingly purchasing counterfeit or sub-potent drugs.
5. If FDA is not aware of adverse events associated with approved drugs sold online, why does the agency think that unlawful online sale is a big problem?
We know that adverse events are under-reported and we know from history that tolerating the sale of unproven, fraudulent, or adulterated drugs results in harm to the public health. It is reasonable to expect that the illegal sale of drugs over the Internet and the number of resulting injuries will increase as sales on the Internet grow. Without clear and effective law enforcement, violators will have no reason to stop their illegal practices. Unless we begin to act now, unlawful conduct and the resulting harm to consumers most likely will increase.
6. Why shouldn't the online pharmacy industry be self-regulated?
Industry self-regulation has a role to play when applied to legitimate businesses. However, self-regulation is an insufficient mechanism to control illegal practices.
7. Some Websites offer to prescribe medication based only on a questionnaire. Is this a safe practice? Is it legal?
Unlike the traditional relationship between a patient and the patient's health care professional, some online practitioners issue prescriptions in the absence of a physical examination or direct medical supervision. According to the American Medical Association, a health care professional who offers a prescription for a patient the practitioner has never seen before and based solely on an online questionnaire generally has not met the appropriate medical standard of care. As a result, patients may receive a drug that is inappropriate for them to use and may sacrifice the opportunity for a correct diagnosis or the identification of an underlying medical condition for which use of the prescription drug may be dangerous.
It is a violation of the Federal Food, Drug, and Cosmetic Act to dispense prescription drugs without a valid prescription. FDA will work with the states to determine the validity of online prescriptions and to bring enforcement actions under state law, federal law, or both, as appropriate. In addition, several state boards of medicine have ruled that such practice is medical misconduct and have fined and suspended the licenses of health care practitioners who have prescribed drugs in this manner.
8. How many states have acted against web sites selling prescription drugs?
Several states have taken or are contemplating taking action against illegitimate online sellers of prescription drugs. Fourteen states (Arizona, California, Colorado, Connecticut, Illinois, Michigan, Kansas, Nevada, New Jersey, Ohio, Texas, Washington, Wisconsin, and Wyoming) have already taken some action against physicians prescribing drugs over the Internet. Although most of these cases involve cease and desist orders, some states have assessed fines and are contemplating stiffer penalties. One state has issued a temporary restraining order against an Internet pharmacy selling drugs without a valid prescription.
9. Who will FDA refer complaints to at the state level?
FDA has been working with the National Association of Boards of Pharmacy, the Federation of State Medical Boards, and the National Association of Attorneys General to establish points of contact in all states specifically for Internet related problems. Both the FDA and NABP Websites have online reporting forms for consumers to use in referring complaints to the appropriate regulatory authorities.
10. How will FDA integrate its efforts with the White House Electronic Commerce Working Group?
FDA believes its activities will complement those of the White House working group and are consistent with the Administration's July 1997 Framework for Global Electronic Commerce and the President's November 1998 Memorandum on Successes and Further Work on Electronic Commerce. Effective consumer protection is necessary to foster legitimate electronic commerce. Because legitimate electronic commerce activities may involve the practice of medicine or the practice of pharmacy, FDA will work with state law enforcement and regulatory bodies to better define the boundaries of legitimate online practices. By reducing the availability of illegal and harmful products in the electronic commerce marketplace, FDA enforcement activities will increase consumer confidence in the Internet.
11. What are international organizations like WHO doing about Internet prescribing and dispensing?
The World Health Organization is in the process of developing a guide entitled "Medical Products and the Internet." In addition to providing tips on finding reliable health and medical information on the Internet, it will provide advice on buying medical products online. FDA participated in the development of this guide.
12. Can an American patient get a medication not approved in the U.S. from a foreign dispenser?
As a general matter, it is illegal to import an unapproved drug into the U.S. However, under FDA's personal importation policy, FDA has authorized its inspectors to use their enforcement discretion to allow U.S. residents to import certain products under certain limited conditions. Under this policy, FDA may allow a U.S. resident to bring into this country an unapproved drug for their personal use for a serious condition, if there has been no commercialization or promotion of the drug to U.S. residents.
13. Is it illegal for a foreign pharmacy to ship prescription medicines into the U.S.?
It is illegal for anyone, including a foreign pharmacy, to ship prescription drugs that are not approved by FDA into the U.S. even though the drug may be legal to sell in that pharmacy's country. Under the scheme that Congress established to ensure that drugs are safe and effective, drugs are tested and test results are thoroughly reviewed by FDA scientists. U.S. law also requires that products approved for sale in the United States have their formulation approved by FDA, be made in a plant registered with FDA, and be produced under quality standards enforced by FDA.
Prescription drugs available from a foreign pharmacy that are products that FDA has not approved; products with similar, but not identical formulations as FDA-approved products; products not made under the quality standards required by U.S. law or labeled according to U.S. requirements; or products not stored or distributed under the quality conditions required in the U.S. cannot be legally sold in the U.S.