33 T. Jefferson L. Rev. 297 (2010-2011)
Patients at Risk: The Need to Amend the Food, Drug, and Cosmetic Act to Ensure the Safety of Imported Prescription Drugs

handle is hein.journals/tjeflr33 and id is 301 raw text is: PATIENTS AT RISK: THE NEED TO
AMEND THE FOOD, DRUG, AND
COSMETIC ACT TO ENSURE THE SAFETY
OF IMPORTED PRESCRIPTION DRUGS
INTRODUCTION
Prescription drugs are found in the medicine cabinets of almost
every American household. Millions of Americans take prescription
drugs daily, and many have turned to generic drugs because they can
cost between 30% and 80% less than brand-name equivalents.'
According to the Food & Drug Administration (FDA), generic drugs
must be a bioequivalent of the brand name drug, meaning they have
the same dosage, quality, strength, method of ingestion, and active
ingredients.2
The United States has until recently operated as a closed drug
distribution system heralded as the gold standard for drug safety.
Globalization, however, has expanded the prescription drug market
and increased the quantity of drugs produced in foreign countries with
lax regulatory systems.4    These foreign-made drugs are being
1. Michelle Meadows, Saving Money on Prescription Drugs, U.S. FOOD & DRUG
ADMIN.,   http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrug
Preparedness/ucml34215.htm (last updated July 14, 2010) (showing that Americans
are purchasing generic prescription drugs from foreign countries at cheaper prices,
but this comes with inherent health risks).
2. Drugs @ FDA Glossary of Terms, U.S. FOOD & DRUG ADMIN.,
http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm (last updated Jan. 7,
2010).
3. DEPT. OF HEALTH AND HUMAN SERVICES, HHS TASK FORCE ON DRUG
IMPORTATION: REPORT ON PRESCRIPTION DRUG IMPORTATION, at X [is this the page
number?] (2004), available at http://archive.hhs.gov/importtaskforce/Reportl220.pdf
[hereinafter HHS TASK FORCE ON DRUG IMPORTATION] (explaining that the U.S.
traditionally had a closed drug distribution system that ensured a high level of
safety) .
4. E.M. Abler, Plugging the GA77S and WTOS: Toward a Globalized
Pharmaceutical Regulatory Framework, 29 BIOTECHNOLOGY L. REP. 3, 8 (2010)
[hereinafter Abler]; see also Margaret A. Hamburg, M.D., Comm'r of Food and
Drugs at the Ctr. for Strategic and Int'l Studies, FDA and the American Public: The
Safety of Foods and Medical Products in the Global Age (Feb. 4, 2010), available at
http://www.fda.gov/NewsEvents/Speeches/ucml99926.htm [hereinafter Hamburg];

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