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July 23, 2003
Imported Prescription Drugs
Don’t Need to Poison to be Dangerous
Dear Colleague:
Many proponents of prescription drug
importation/reimportation begin by stating, "people are already buying their drugs
from Canada, Mexico, and all other points across the globe. If this is so dangerous, then
where are all the bodies?" In other words, if purchasing foreign drugs is so
dangerous, shouldn’t we expect to see many deaths as a result of taking them? But to
expect that a U.S. patient will die when a drug product purchased from overseas is
ingested both is overly simplistic and misunderstands the complex risks associated with
using prescription drugs that are sub- or super-potent, contain unknown ingredients, or
are contaminated with undetectable bacteria or other contaminants.
Moreover, counterfeiters, if they are to be
successful, will not operate in a manner so clumsy or obvious that their products
immediately are detected as fatal. Counterfeit, adulterated, improperly stored, or expired
products do not need to cause instant death or immediate and recognizable injury. These
knock-offs and diluted, mishandled, and stolen products are so dangerous precisely because
their effects are not immediately noticeable to either the patient or the practitioner.
Consider the situation in Florida, widely
reported in the press, where nineteen individuals were indicted for distributing millions
of dollars in fake cancer, AIDS, and other drugs. Many of these were sensitive injectable
products that were diluted to the point that the active ingredients could not have been
effective or were completely replaced with water contaminated with bacteria.
The unfortunate AIDS or cancer patients who
took these drugs would likely not have died instantly. Indeed, those patients and
their doctors would have had a very difficult time detecting what had gone wrong and then
concluding that the patient wasn’t feeling better because the drug was bogus. If
patients with cancer or HIV disease do not improve, the conclusion is far more likely to
be that the patient is simply no longer responding to the medication. What patient or
doctor would ever suspect the reason for poor response to a drug, or for declining health
status of an already very ill patient, was that the product was a flat-out fake?
That is the point. When drugs are
improperly stored, diluted, expired, or replaced with outright counterfeit ingredients, a
patient may not simply drop dead. Instead, the effects can be far more subtle – the
drug just doesn’t work. To a cancer patient or an individual with high blood
pressure, that can mean increased illness, new symptoms, and, possibly, premature death.
We also hear the argument that FDA can
promulgate regulations to ensure "testing" for counterfeits or otherwise
adulterated product, using new technology. That, too, reflects a serious misunderstanding
of the difficulty of such testing. It further fails to recognize that the incorporation of
anti-counterfeit technology into medications often means that the only person able to do
valid authenticity testing is the actual manufacturer. Such testing is also very
expensive, time consuming, and difficult. I urge you to visit one of FDA’s existing
facilities that does such testing to see what it involves. At the present time,
inexpensive and broadly available drug testing simply doesn’t exist.
And about those special security features
or other forms of technology that H.R. 2427 envisions will be added to drug products,
because Congress orders the Secretary to do so? I would welcome such features, with or
without legislation, but to date, no such fool-proof technology exists. If it were
available and affordable, I would submit that the very cancer and AIDS drugs –
selling for thousands of dollars for a few vials, each the size of a penny – would
already contain such features. It is not good enough to say that "the Secretary shall
come up with such features . . ." Drug counterfeiting costs the industry millions
each year. It is in the drug companies’ interest to put security features on their
products. Yet each time a new hologram or other marking is added to a drug product, it is
quickly counterfeited.
We all await that day when inexpensive
technology allows special hard-to-counterfeit security features to be inexpensively added
to goods such as prescription drugs. But until that day arrives, the present restrictive
system best serves the safety interests of the U.S. consumer.
I urge my colleagues to examine this bill
closely. Like the drugs it would allow into our country, this bill promises what it cannot
deliver – safety and security of our pharmaceutical marketplace after tearing down
the very prohibitions and conditions that have made America the safest place in the world
to fill a prescription. We already have a crisis of high pharmaceutical prices. Let us not
add to that another crisis from a flood of unsafe, counterfeit, or ineffective drug
products onto American pharmacy shelves.
Sincerely,
JOHN D. DINGELL
RANKING MEMBER
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