Deseret News (Salt Lake City): Drug reimportation too risky

Prescription drug reimportation is a complex issue that filters down to a simple choice: cheap drugs, or safe and effective drugs. Although the House of Representatives voted last week to allow reimportation whereby prescription drugs from foreign countries would be allowed into the United States with few safeguards but at reduced prices, I joined 52 of my Senate colleagues last week in a letter to voice my support for the latter choice: safety and effectiveness.

Nobody has a greater desire than I to make prescription drugs more affordable, particularly for our seniors and the disabled, who depend so heavily upon pharmaceuticals for their quality of life. I co- authored the 1984 bill that, in essence, brought generic drugs to the marketplace to become the force for competition and affordability that they are today.

But there are some products that simply do not belong in a virtual discount bin and should not be available through fly-by-night Internet vendors, and prescription drugs are at the top of the list.

First, reimported drugs are a threat to the innovation Americans and the rest of the world have come to expect from our pharmaceutical industry. Canada and other countries with lower drug prices generally import superior American products but impose price controls to keep costs down. However, it can cost as much as $1 billion to produce a new drug, test it, win FDA approval, educate doctors, and make the drug available to patients. No pharmaceutical company could go through this immensely expensive process without a chance to recover some of its costs, which will not be possible if we impose in America, however indirectly, Canadian-style price controls.

Second, but more importantly, the safety and efficacy of imported prescription drugs under this bill cannot be assured, no matter what the bills proponents may claim. The possibility of mistake or deception is too great. Already, the FDA has documented many cases of what appeared to be FDA-approved imported drugs that in fact were contaminated or counterfeit, contained the wrong product or incorrect dose, were accompanied by inadequate directions or had outlived their expiration date. These drugs would be at a minimum ineffective and could actually be harmful or fatal.

I doubt many people who support this measure actually know the negative effects it would have on the quality and safety of our drug supply. Briefly, the bill as it is written would:

-- Remove the existing requirement that the government certify drug imports are safe. Health secretaries in both the Clinton and Bush administrations have said they are unable to make this assurance. I would note that Canadian health officials have stated they cannot assure the safety or authenticity of drug products exported from their country.

-- Allow drug imports manufactured and shipped from anywhere in the world, not just Canada, as is widely believed.

-- Allow sales of pharmaceuticals by companies not licensed by states to practice pharmacy, and remove limitations on the amount or frequency of drug imports permitted for individuals.

-- Allow U.S. pharmacists to obtain allegedly FDA-approved prescription drugs from foreign sources that are not subject to federal oversight or regulation, U.S. standards for storage and safe handling, or U.S. penalties for failure to comply with safety requirements.

-- Hamper the FDA's ability to crack down on substandard or counterfeit drug products imported into the United States by stripping its authority to act on products sold directly to an individual.

-- Allow risky drugs that are currently available in the United States only under strict safety controls to be imported at any amount or frequency to anyone, even those who are at high risk, to be seriously injured by the medication.

These safety concerns are real, and proponents of reimportation ignore them not at their own risks but at the risk of the lives of millions of Americans. If we truly care about our seniors and other patients who depend upon prescription drugs, we should not expose them to what amounts to pharmaceutical Russian roulette.

Nor do we have to. Congress is inches away from adding a landmark prescription drug program to Medicare, giving millions of seniors and the disabled increased access to vital prescription drugs. We are also reviewing ways to streamline federal regulation so drug production is less costly, enhancing access to lower-cost generic drugs, and reducing prices by opening the Medicare drug program to private-sector competition.

My Senate colleagues and I will continue to look for ways to make prescription drugs more affordable. We agree that prices are too high. But we will not do so by sacrificing the safety of the American drug supply. That is too high a price.

Orrin Hatch is Utah's senior U.S. senator.