Consumer health Essay

This essay has a total of 2114 words and 13 pages.

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
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