FREE ESSAY ON CONSUMER HEALTH

CONSUMER HEALTH

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 contacted
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 contacted 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 contacted 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
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]