Is Consumer Health and Safety in Jeopardy With the implementation of Self-Prescription Drug Internet Sites? Amanda C. Feitner GUS 72-001: Urban Affairs-Consumers In the Marketplace: Your Legal Rights and Responsibilities. Prof. John E. Kelly, J.D. April 17, 2000 The expeditious augmentation of consumer product transactions taking place on the Internet have developed new risk for the public's health and safety, especially with the rise of online self-prescription drug sites. Online Pharmacies have been created to benefit the consumer but pose many risks for credulous purchasers, increased health fraud, and unique challenges to regulators, law enforcement, and policymakers. With these latest technological advancements, former regulations utilized by the Food and Drug Administration (FDA) concerning the distribution of prescription and over the counter drugs have to some extent become obsolete. This has required that the FDA along with the combined efforts of other organizations such as the Federal Trade Commission (FTC), create new regulations to protect consumers. The evolution of online prescription Internet sites has brought several advantages to consumers, allowing individuals to attain ever-increasing amounts of knowledge to improve their understanding of health issues and treatment options. "Last year alone more than 22 million Americans used the Internet to find medical information. According to Investor's Business Daily, 43% of web surfers access health care data online each year. Health concerns are the sixth most common reason people use the Internet, and according to the market research firm, Cyber Dialogue Inc., this number is growing 70 percent a year." The leading attractions to purchasing consumer products online are speed, privacy, ease of choosing and ordering products, and reduction in possible prescription errors with the use of computer technology to transmit prescriptions from doctors to pharmacies. Other benefits include: lower prices through increased competition among licensed sellers; greater availability of drugs for people with difficulties causing inability to get to the pharmacy or people who may live a great distance from the pharmacy; the ease of comparative shopping among many sites to find the best prices and products; and greater convenience and variety of products for all customers who prefer online ordering of drugs. While there seems to be vast amounts of benefits with these online drug prescription sites for consumers, the public must remember that they are at risk from avaricious sites or individuals that run them, which do not have the best interests of the consumer in mind. Over approximately 200 domestic sites have been identified by the National Association of Boards of Pharmacy and the American Medical Association identified over 400 sites that both dispense and offer a prescribing service, half of which are located in foreign countries. This sizeable variety of companies, which are expanding everyday, give rise to numerous concerns for the consumer and challenges for government at both state and federal levels. Such concerns include illegal sale of drugs not approved by the FDA, distribution of counterfeit drugs, prescription drugs dispensed without a valid prescription, fatal interactions between drugs that may occur because of sites only requiring one to fill out a questionnaire to obtain the prescribed drug without prior knowledge of medical history, and products marketed with fraudulent health claims. "The unique qualities of the Internet, including its broad reach, relative anonymity, and ease of creating new websites or removing old ones, pose new challenges for the enforcement of existing laws." The technological advancements of electronic commerce have outdated the establishment of the FDA and its system of drug regulation as it exists today. The FDA's system of drug regulation reviews new drugs to assess their safety and efficacy. In addition, it only permitted licensed health care professionals with the necessary education and training to administer prescription drugs, which reduced the risks that may occur from lack of knowledge by individuals without the proper credentials. The global nature of the Internet and the ability for websites to be made up of several related sites and links allows illegal transactions to occur readily thereby placing consumers health and safety at extreme peril. The occurrence of illegal transactions from online pharmacies becomes possible because foreign sites can be accessed and used to obtain drug prescriptions. Foreign countries have different drug regulations than those in America and create a difference in the legality of all existing drugs. Permitting the purchase of drugs from foreign sites may allow individuals to purchase drugs legal in that country but illegal in America. Another factor pertaining to foreign drug purchases made from online pharmacies is that shipment of drugs from foreign countries into the U.S. is illegal. To insure that the shipment of drugs from places out of jurisdiction do not occur the Drug Enforcement Administration has enforced laws that imposed the importation of controlled substances. This makes law enforcement increasingly complex and hinders investigations of sites that are breaking laws because companies can shut down the site just as fast as they can create a new site. When the Internet is used for an illegal sale, the FDA must establish the same elements of a case, bring the same charges, and take the same actions as it would if another medium, such as a storefront or a magazine, had been used. Under the Federal Food, Drug, and Cosmetic (FD&C) Act unlawful conduct involving online drug sales that have been identified by the FDA, allows them to take legal action against: · The importation, sale, or distribution of an adulterated or misbranded drug; · The importation, sale, or distribution of an unapproved new drug; · Illegal promotion of a drug; · The sale or dispensing of a prescription drug without a valid prescription; and · Counterfeit drugs. When an illegal site has been reported, the Office of Regulatory Affairs (ORA) and the Office of Compliance in the Center for Drug Evaluation and Research the primary organization within the FDA for regulating online drug sales is notified. The FDA has already investigated and brought several cases for criminal prosecution and civil enforcement actions against some online sellers of drugs and other FDA regulated products, particularly the sellers of drugs not approved by the Agency. For example, in July of 1996, the Office of Criminal Investigations (OCL) was ed by a womens health care provider to advise that several clients had directed her to an Internet site promoting an abortion kit. This kit proposed serious health risks to women when used without a doctor's supervision because of possible side effects that caused heavy vaginal bleeding and death. An anonymous purchase had been made on the OCL's behalf and the company responded sending out an abortion kit. The OCL was able to trace the site Easy Life Labs in Columbia, South America, but this company temporarily went off-line. In March of 1997, the OCL was ed once again that this same company was online again. The OCL notified the foreign Drug Company's U.S. Internet Service Provider (ISP) and told them that one of their subscribers was criminally violating the FD&C Act and the service voluntarily removed violative ads. As cases like the above example have increased with the widespread incorporation of online pharmacies into the consumer world, the FDA has ed several agencies and States and initiated the address of the concerns brought on by these sites. Several new programs have been introduced to verify legitamacy of Internet sites dispensing prescription drugs. One new program announced by the National Association of Boards of Pharmacy (NABP), known as the Verification of Internet Pharmacy Practice Sites, or VIPPS, will provide a NABP "seal of approval" to sites meeting the organization's standards. The FDA also believes that by working with the States, that they will be able to regulate the domestic sale of both approved and unapproved drugs, as well as the sale of prescription drugs without a valid prescription thereby reducing health fraud. The FDA has also drafted and devised an action plan concerning online pharmacies. The FDA has identified five major areas of focus pertaining to the regulation of online drug sales which are to: · Customize and expand the agency's regulatory and criminal enforcement efforts: · Identify when and with which Federal agencies FDA should partner in joint activities; · Partner with State bodies to address domestic Internet sales; · Engage in public outreach; and · Provide input to congress regarding legislation. Although many actions have been taken to curb health fraud and unsafe conditions for consumers, the public still remains at extreme risk by purchasing drugs from online pharmacies. Consumers are still subjected to risks involving factors such as the illegal sales of drugs because it is difficult to regulate foreign sites, health fraud, and counterfeit drugs that may be used in place of the perceived drug thought to have been purchased. Regulating foreign sites is one of the most difficult tasks yet to be accomplished by the FDA. Regulation is hard to control because the FDA and other federal organizations have limited jurisdiction concerning sellers of prescription drug sales from other countries. They are working closely with the post offices to try and stop illegal drugs from crossing state borders but finding these packages is a task in itelf. Health fraud allows consumers to fall prey to health gimmicks. These fraudulent health products manipulate consumers into spending billions of dollars a year. FDA shares federal oversight of health fraud products with the Federal Trade Commission. But because of limited resources, say Joel Anderson, team leader for the nontraditional drug compliance team in FDA's Center for Drug Evaluation and Research, the agency's regulation on health fraud products is based on a priority system that depends on whether a fraudulent product posses a direct or indirect risk. The most extreme hazard that consumer's are exposed to with the purchase of prescription drugs online are those which deal with the threat that the drug which they purchased could be counterfeit or tampered with and cause harm or serious complications. As a guide to consumers when purchasing drugs online the FDA has issued tips and warnings for consumers to be aware of which include: · Purchasing a medication from an illegal Website puts you at risk . You may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all. · Taking an unsafe or inappropriate medication puts you at risk for dangerous drug interactions and other serious health consequences. · Getting a prescription drug by filling out a questionnaire without seeing a doctor poses serious health risks. A questionnaire does not provide sufficient information for a health-care professional to determine if that drug is for you or safe to use, if another treatment is more appropriate, or if you have an underlying medical condition where using that drug may be harmful. The American Medical Association has determined that this practice is generally substandard medical care. FDA agrees. The Internet generates a haven where numerous illegal transactions can be carried out with almost no detection by authorities. The development of online pharmacies, although seemingly bring advantages to patrons, ultimately creates an unprotected environment for consumers. While the FDA and other organizations take action to improve the out dated safety regulations for online pharmacy purchasing, these sites still pose threats to the public's health and safety. Bibliography Woodcock, M.D., J. (1999). Testimony By Janet Woodcock, M.D. FDA Magazine (online). 30 July 1999. http://www.fda.gov/ola/drugsonline.html [Accessed 11 April 2000] Henny, M.D., J. (2000). Testimony By Jane E. Henney, M.D., FDA Magazine (online). 21 March 2000. http://www.fda.gov/ola/2000/pharmsales.html [Accessed 11 April 2000] Writing HTML: Enforcement of Existing Laws Regarding the Sale of Prescription Pharmaceuticals Over the Internet (online).(1999). FDA Magazine (online). 15 December 1999. http://www.fda.gov/oc/buyonline/existlaws.html [Accessed 11 April 2000] Writing HTML: Online Pharmacies FAQS (online).(2000). FDA Magazine (online). 28 January 2000. http://www.fda.gov/oc/buyonline/faqs.html [Accessed 11 April 2000] Kurtwell, P. (1999). How to Spot Health Fraud FDA Magazine (online). 15 October 1999. http://www.fda.gov/fdac/features/1999/699_fraud.html [Accessed 11 April 2000] Writing HTML: Tips and Warnings For Buying Online (online).(2000) FDA Magazine (online). 6 March 2000. http://www.fda.gov/oc/buyonline/tips_warnings.html [Accessed 11 April 2000] Bibliography Bibliography Woodcock, M.D., J. (1999). Testimony By Janet Woodcock, M.D. FDA Magazine (online). 30 July 1999. http://www.fda.gov/ola/drugsonline.html [Accessed 11 April 2000] Henny, M.D., J. (2000). Testimony By Jane E. Henney, M.D., FDA Magazine (online). 21 March 2000. http://www.fda.gov/ola/2000/pharmsales.html [Accessed 11 April 2000] Writing HTML: Enforcement of Existing Laws Regarding the Sale of Prescription Pharmaceuticals Over the Internet (online).(1999). FDA Magazine (online). 15 December 1999. http://www.fda.gov/oc/buyonline/existlaws.html [Accessed 11 April 2000] Word Count: 1989
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