**American Medical Association**

**Oral Statement by**

**Rebecca J. Patchin, MD**

**HHS Task Force on Drug Importation**

**May 14, 2004**

Good afternoon. My name is Rebecca J. Patchin, MD. I am an
anesthesiologist, a pain management specialist and a member of the
American Medical Association's Board of Trustees.

I am in solo practice in Riverside, CA, where I have had a number of
patients cross the border into Mexico in an attempt to buy, more
cheaply, the prescriptions I write for them.

Am I concerned about this? Of course.

In fact, this is a concern shared by the AMA and practicing physicians
across the U.S.

We are concerned because when patients go outside the country to
purchase their drugs, there is no way for physicians to be certain that
the drugs we prescribe for them are the drugs they are going to receive.

Whether patients get their prescription drugs from Mexico, Canada, or
the European Union the concerns are the same:

That our patients are getting the right drug, in the right dosage, in
the right way.

What the "right way" means is that the drugs come from manufacturers,
wholesalers, or retailers, whether Internet or "brick and mortar," that
can assure quality while at the same time, balancing against the need
for patients to get their prescriptions at the lowest possible price.

But when it comes to drug importation, patient safety [is]{.underline}
the AMA's number one priority.

At its 2003 Annual Meeting, the AMA's House of Delegates chose not to
adopt a resolution supporting prescription drug importation.

Concerns over patient safety were at the center of the AMA's debate.

On the legislative front, the AMA also opposed HR 2427, The
Pharmaceutical Market Access Act of 2003, primarily because the bill
lacked a provision that would have required the Secretary of HHS to
certify the safety of imported drugs.

The only way to assure the safety of imported drugs is to make certain
that all drugs for sale to patients in the U.S. are FDA approved.

That means, among other requirements:

-   the drug has been reviewed and approved by the FDA for safety and
    efficacy;

-   the drug manufacturer has met all U.S. laws and regulations for good
    manufacturing practices;

-   the FDA has the authority to inspect all manufacturing facilities;

-   the drug has met all FDA labeling and packaging requirements; and
    finally

-   that the drug's chain of custody can be assured and traced.

Admittedly, these requirements would demand significant federal revenue
but if we are to allow drug importation, these measures are necessary to
protect the American people and to preserve our stringent and very
effective drug approval process.

Another AMA concern is drug counterfeiting.

In a recent FDA report, drug counterfeiting outside the U.S. was
described as "widespread and affecting the drug supply of both
developing and developed countries."

In some instances, counterfeit drugs accounted for more than half of a
country's drug supply.

The AMA has concerns that if prescription drugs are allowed to be
imported from foreign countries, counterfeit drugs will be more likely
to enter our now - well protected - drug distribution system.

If we allow importation, the distribution system must be closed, and all
drugs must be subject to reliable, electronic track and trace
technology - to secure the integrity of the drug supply chain - and to
prevent the importation of counterfeit drugs.

The AMA is also concerned with whether or not individual patients will
be allowed to import drugs directly via the Internet. This is a largely
unregulated area with a number of rogue web sites already selling
prescription drugs of unknown quality, and often without a valid
prescription.

This problem will likely increase if direct importation by patients is
legalized.

Without the safeguards I have described, the American people cannot be
certain that the imported drugs they are taking are safe, effective, and
of high quality.

These may seem like high standards to demand, especially when many
patients struggle to pay the high costs of their prescription drugs.

However, if we permit unsafe, ineffective, adulterated, misbranded,
expired or counterfeit drugs to reach our patients it may result in harm
to those patients, or even death.

In the field of pain management, for example, a subpotent drug can mean
the difference between a pain score of 6 on a scale of 1 to 10 and a
pain score of 9 which, if you have ever experienced such pain, is a
significant difference.

While the AMA's goal here today was to lay out the patient safety
concerns with respect to drug importation, other questions will also
need to be answered such as:

Whether an adequate supply of FDA-approved drugs in foreign countries
would exist to make importation feasible,

-and-

What the economic reaction of the drug companies or other countries
would be to widespread importation.

These, and especially the patient safety issues must be weighed
carefully before a decision should be made on drug importation.

Thank you for your time and I welcome any questions.