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.
