SUMMARY:
Legislation
was introduced at the end of the 106th Congress
that regulates Internet sale of prescription
drugs. The legislation was introduced by Senate
HELP Committee Chairman Jeffords (R-VT) and
Ranking Democrat Kennedy (D-MA). The bill, S.
3208, The Internet Prescription Drug Consumer
Protection Act of 2000, would create a new Federal
definition of "interstate Internet seller". These
sellers would be required to post and disclose on
their website certain information relating to
their pharmacy license and business operations so
consumers and law enforcement agencies can
determine the legitimacy of the internet site. The
bill would also create a new right for state
attorneys general to seek a Federal injunction
against internet sellers who violate the
disclosure provisions and for other violations of
the Federal Food, Drug and Cosmetic Act. The
definition of an interstate Internet seller was
broad enough to create concerns that some
community pharmacies that operate websites would
be affected by this bill. The legislation was not
passed in 2000, but will serve as a starting point
for next year's discussions on Internet pharmacy.
STATUS:
Policymakers have concerns
about the patient safety implications of
prescription medications sold through so-called
"rogue" online Internet sites. These sites sell
prescription medications, primarily "lifestyle
medications" such as Viagra and Propecia, usually
without a physical exam, and sometimes without a
legitimate prescription. Many of the pharmacies
that fill prescriptions for these websites are
located overseas, and are shipping unapproved,
counterfeit, or adulterated products into the
country.
Ostensibly, the purpose of this legislation is
to regulate those sites that were selling their
prescriptions through the Internet, for which
licensure status and legitimacy were uncertain.
However, the legislation contains a broad
definition of interstate Internet seller that
would include some traditional pharmacies with
Internet sites that are already regulated by state
licensure authorities. NACDS suggested that the
definition of Internet seller be narrowed to
include only those Internet sites that principally
receive their orders for prescription drugs
through the Internet. This would avoid capturing
traditional pharmacies that only conduct limited
sales of Internet prescriptions, primarily
refills.
OUTLOOK:
Legislation will likely be
reintroduced again next year to regulate
prescription Internet sales. It will be key for
community retail pharmacy to further narrow the
definition of "Internet seller" so that
traditional community pharmacies are not included
in the regulatory scheme.
CONTACT:
John Coster and Paul Kelly
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