E-drug: Products recalled in Australia (cont'd)
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Sarah Sellers mentioned in a prior e mail that as the result of a
Supreme Court ruling in April 2002, regulations which provided
ederal oversight for "pharmacy compounding" have been
nullified. This case is THOMPSON, SECRETARY OF HEALTH
AND HUMAN SERVICES, ET AL. v. WESTERN STATES
MEDICAL CENTER ET AL. Perhaps the readers of e drug might
like some more information about this case.
Briefly, the relevant part of the Food and Drug Administration
Modernization Act of 1997 (FDAMA) exempts "compounded
drugs" from the FDA standard drug approval requirements,
provided that the providers of the compounded drugs can prove
that: 1) the compounding was performed by a licensed pharmacist
or physician 2) , the prescription was "unsolicited" and 3) the
providers "not advertise or promote the compounding of any
particular drug, class of drug, or type of drug,"
The Supreme Court found that the "solicitation" and "advertising"
portions of FDAMA violate the First Amendment's free speech
guarantee in part, because the FDA could have drawn the line
between compounding and large-scale manufacturing in
non-speech" ways other than having the solicitation and
advertising restrictions.
These two provisions could have been separated from the rest of
the statute and invalided just by themselves, leaving the rest of the
statute intact. The question of "severing" the two offending parts of
the statute was answered in two different ways by two different
lower courts.The U.S. Supreme Court refused to rule on the
question of whether or not these just two parts could be removed.
Instead, the Supreme Court ruled just on the constitutional "free
speech" issue and invalidated the entire statute.
Warren Kaplan, Ph.D., JD, MPH
Consultant: Public Health/Intellectual Property
Adjunct Assistant Professor International Health
Boston University School of Public Health
e-mail: wak22@attbi.com
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