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Frequently Asked Questions House Bill - H.R. 328 PDF Print E-mail
PHARMACEUTICAL MARKET ACCESS ACT of 2005
H. R. 328 (Gutknecht-Emanuel-Sanders) and S. 109 (Vitter)

1.         Question: Won’t allowing the importation of prescription drugs create an influx of fake drugs from third-world countries?

Answer: The current prescription drug market is like the Wild West.  There are countless unregulated methods in which consumers can gain access to non-FDA-approved prescription drugs.  The PHARMACEUTICAL MARKET ACCESS ACT of 2005 (H.R. 328) allows for the importation of prescription drugs from industrialized countries chosen by the FDA in the MEDS Act of 2000 – such as the European Union, Australia, Canada, New Zealand, and Switzerland.  By creating a system that offers safe prescription drugs at reasonable prices, these dangerous drugs peddlers will go out of business.

2.         Question: Isn’t importing prescription drugs from other countries unsafe because no other country has a safety system as good as the FDA in place?

Answer: H.R. 328 allows pharmacists, wholesalers, and individuals to import only FDA-approved prescription drugs made in FDA-approved facilities.  There have been zero reported deaths from Americans taking imported pharmaceuticals.  On the other hand, the Centers for Disease Control and Prevention have estimated that food-borne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the U.S. each year – yet no one suggests banning the importation of food.  In the fall of 2003, green onions imported from Mexico to Pennsylvania infected 660 people with Hepatitis A and killed three people.

3.         Question: Won’t importation of pharmaceuticals lower safety standards on prescription drugs?

Answer: H.R. 328 raises safety standards on all prescription drugs sold in America.  Pharmaceutical manufacturers will be required to use counterfeit-proof technology on all drugs distributed in America.  The bill also includes language written by the FDA that would require wholesalers to test each shipment unless the packaging uses anti-counterfeit technology.

4.         Question: Aren’t all pharmaceuticals sold in the U.S. made in the U.S.?

Answer: Our domestic pharmaceutical supply is manufactured around the world.  H.R. 328 allows for the importation of pharmaceuticals manufactured in the FDA-approved facilities in 25 countries.  For example, millions of Americans use the cholesterol lowering drug Lipitor which is only made in Dublin, Ireland.

5.         Question: Won’t individuals be able to import addictive and dangerous pharmaceuticals?  Couldn’t imported medicines be damaged in transit by lack of refrigeration or other mishandling?

Answer: H.R. 328 does not allow for the importation of narcotics or biologics.

An unaffordable drug is neither safe nor effective.
Prescription Drug Costs