Drug reimportation bill passes Congress despite heated opposition

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1. Supporters say it will end price subsidies; opponents say it imports price controls and will hinder R&D.

2. HHS says it won’t be able to monitor safety

3. One solution -  cut FDA approval red tape

4. Pro and con statements by Rep. Ron Paul. M.D. & “Medicine Men” column

5. Attend a congressional town meeting during August

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In a late night/early morning session before it adjourned for the August recess, the House of Representatives passed H.R. 2427, the Pharmaceutical Market Access Act.  Both sides of the issue gathered into those “strange bedfellows” coalitions of democrats and republicans, conservatives and liberals.

 

The bill would allow consumers to import prescription drugs from 25 other countries, including Canada and Mexico.  The Senate passed a different version in its  Medicare bill earlier this month, so the final bill will have to worked out in conference committee. 

 

Free market supporters have lined up on both sides of this issue.  Those supporting the bill say it eliminates unfair, artificial government SUBSIDIES.  Opponents see it as allowing the importation of other countries’ artificial price CONTROLS, and will make fewer funds available for R & D.

 

There is disagreement on the safety issue as well.  Two HHS secretaries under both the Clinton and Bush administrations have strongly stated on the record that it will be impossible to monitor the imported drugs.

 

AAPS has not take a position on this bill, but some of our prominent members have.  Pasted below are two articles – the first, a brief statement by Congressman Ron Paul, M.D. in support, and in opposition, the “Medicine Men” column written by Drs. Glueck and Cihak, former AAPS President.

 

Most of us agree on one of the major contributors to drug costs – the government red-tape required for FDA approval.  These government hoops add an estimated at $800 million.

 

Since the bills will be worked out in conference, there is still time to talk to your Members about this during the recess in August.  Attend a town meeting or call the local offices.  In a subsequent alert, we’ll brief you about other bills pending so you can make your calls or speak up at a meeting.

 

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Paul Supports Importation of Affordable Prescription Drugs

June 25, 2003 -- As the House of Representative debates a Medicare prescription drug bill this week, Congressman Ron Paul responded to efforts by the pharmaceutical industry to block changes that would lower the cost of medicine for millions of Americans.  Paul strongly supports changes to FDA regulations that would allow prescription drugs to be reimported from foreign countries, where widely-used drugs often sell for much less than in the U.S.  Paul, a medical doctor for nearly 40 years, is an advocate of innovative market-based solutions to rising drug costs.  He is a member of the House Caucus for Affordable Pharmaceuticals, which seeks to eliminate rules and regulations that benefit drug companies at the expense of consumers.

“Drug reimportation is critical to lowering prices,” Paul stated.  “Reimportation allows American consumers, particularly seniors, to benefit from worldwide price competition.  It’s outrageous that the FDA does not permit U.S. citizens to reimport drugs that sell for 30 to 300 percent less outside our borders.  The pharmaceutical companies should not be allowed to profit by this government-enforced price fixing.  How much longer should American consumers be expected to pay much higher prices for identical drugs available in Europe, Canada, and Mexico for a fraction of the cost?”

Paul supports tax credits for seniors to offset the cost of needed medicines, and medical savings accounts to allow tax-free savings to be used to pay for prescriptions.  He also supports legislation that streamlines the FDA approval process to make promising new drugs available more quickly.

Reprinted from NewsMax.com

Drug Reimportation

Michael Arnold Glueck, M.D., and Robert J. Cihak, M.D.
Tuesday, July 22, 2003

Gutknecht Bill Translates to Goodnight, Patients

Sometimes the Powers That Be and the Powers That Wannabe try to bribe you directly. More often, and far more insidiously, they buy you indirectly, by offering to "save you money." The Gutknecht "Drug Reimportation Bill" scheduled for a vote in the U.S. House of Representatives this week seeks to do both.

This item would make it legal for Americans to purchase drugs from 26 foreign countries (including American drugs previously exported), and would suspend the requirement that the Food and Drug Administration certify these pharmaceuticals as safe and effective.

So, what's wrong with that? Your Medicine Men hold no great affection for the FDA, with its bureaucracy-driven drug-approval processes and excessive caution. We do cherish open markets and competition. And there's already a thriving (if illegal) U.S.-Canadian trade in prescription drugs.

Just spend some time at any major border crossing, watching the American seniors head north to get their subsidized drugs ... while Canadians of all ages flock south for treatments unavailable under their system. Not to mention the Internet commerce.

By some estimates, Americans spend well over half a billion dollars annually on such drugs. Those who travel to Canada to purchase drugs need not be alarmed, as this practice remains legal with or without the Gutknecht Bill.

So, what's the dilemma?

There are at least three dilemmas.

The first is patient SAFETY. Free and easy importation could lead to a flood of counterfeit drugs; to an influx of expired drugs that have been repackaged; and to drugs manufactured, stored and transported under unknown conditions. We could be importing poisons – maybe even terrorism.

Further, many advanced American drugs aren't even allowed into other countries. Reimporting what's available somewhere else because it appears to save money may often mean foregoing, or even not knowing about, the most effective treatments.

Which brings us to the second dilemma: MONEY. Contrary to popular belief, Canadians on average pay about as much as we do for drugs. This is especially true for generic drugs whose patents have expired. Since it all depends on what an individual needs, savings may be illusory.

But money here has another aspect. Pharmaceutical research and development costs. The average drug takes about $800 million from inception to FDA approval to market. Profits from sales have to amortize this investment. They also have to pay for all the work that ends up in failure; for drugs for rare diseases that will never turn a profit; and for all the drugs that the firms sell (here and abroad) at discounts for various reasons.

Massive reimportation could well have a sadly deleterious effect on future R&D – especially if coupled with massive violation of patent and other intellectual property rights. Let's not forget that without R&D we might not have combated AIDS or the latest resistant organism de jour.

The third dilemma involves a philosophical MINDSET perhaps best depicted as "Who needs cows? We get our milk from cartons." The Gutknecht bill is just one more part of a massive state assault upon American medicine.

Indeed, the only reason why it's coming to a vote at all is that Missouri Congresswoman Jo Ann Emerson, a Republican, swapped her vote for the overall Medicare bill for a guarantee that the House would vote on reimportation. The Medicare Bill, be it noted, passed the House 216-215.

In return, Emerson demanded a full House vote on a bill by Minnesota Republican Gil Gutknecht that would make it legal for Americans to take "advantage" of socialistic countries' government-imposed price controls by reimporting our own prescription drugs.

Politicians buying citizens, yes. But such wholesale purchase would not be possible were Americans to realize that health care, like the rest of civilization, does not happen automatically, and is never free. And it's being destroyed by those who think that it can be.

This legislation is a reckless political trick. Congressional leaders of both parties know its dangers. Congress needs to say goodnight to the Gutknecht bill.

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Michael Arnold Glueck, M.D., is a multiple-award-winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a former president of the Association of American Physicians and Surgeons.

Contact Drs. Glueck and Cihak by e-mail at [email protected].

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