HEALTHWATCH

HIV/AIDS

Drug Importation Dangerous for America

By Patrick Sammon

There is growing momentum on Capitol Hill to legalize the importation of prescription medication. Republican Senator Charles Grassley from Iowa has introduced legislation to permit imports first from Canada and, then three years later, from the 25 countries in the European Union, three others in the European Free Trade Association, Japan, Australia and New Zealand. Some politicians see this as an appropriate response to complaints from some of their constituents that prescription drugs are over-priced. This simplistic solution will jeopardize the safety of medication users and it will damage an industry that has helped make our country's health care system the best in the world.

Last year's Medicare Modernization Act bill left the importation decision in the hands of experts with the United States Food and Drug Administration (FDA). Political pressure has some lawmakers wanting to change that decision. This is a mistake. The United States has charged the FDA with the responsibility of insuring our drug supply's safety. Let these experts have the final say on safety. The risk of doing otherwise will be tolled in the number of lives lost from using counterfeit or improperly produced drugs. What does the FDA say about importation? "FDA remains concerned about the public health implications of personally imported prescription drugs and the introduction of counterfeit drugs into the stream of commerce," said FDA Associate Commissioner for Policy and Planning William Hubbard in front of a House sub-committee last year.

The quality of prescription drugs in the U.S. is indisputably the best in the world. Regulations for medication approval, manufacturing, and prescribing help ensure safety and quality. Only companies approved by the FDA can manufacture and distribute drug products in the United States. These companies must follow strict guidelines for labeling, packaging, and manufacturing. Furthermore, the FDA approves only those drugs that are proven safe and effective. All of these safeguards work as designed, however importation would jeopardize the safety of our drug supply.

Imported drugs may be counterfeit versions that are unsafe or completely ineffective. The FDA reports 10of drugs worldwide are counterfeit, and in some countries more than half the drug supply is made up of adulterated ingredients. Imported drugs also may be contaminated with harmful materials such as bacteria. The imported medication may contain too little active ingredient, too much of it, or none at all. Also, the medication may be expired or it could have been stored at the wrong temperature. The label also might contain misleading or incorrect information. The FDA has safeguards in place to prevent these things from happening with drugs distributed in the United States. However, consumers cannot be confident that personally imported drugs are safe. These safety concerns should not be ignored. Furthermore, it's a waste of taxpayer money for public, state and federal programs to pay for drugs from Canada or other countries that aren't guaranteed safe.

Aside from safety, there are other problems with importation. Let's look at Canada specifically. There's not enough supply in Canada to provide the United States with its medication needs. A country of 32 million people doesn't have the supply to provide medication for nearly 300 million Americans.

Even though importation remains illegal, the U.S. Food and Drug Administration recently reported that an inspection program in November 2003 found nearly all of the almost 2,000 packages contained copycat foreign versions of U.S. pharmaceuticals that might not be safe. Furthermore, an FDA and U.S. Customs investigation in September 2003 involving "spot examinations" of mail shipments of foreign drugs to U.S. consumers found that 88contained unapproved medications of poor or unknown quality and origin. This problem will only get more severe if importation is legalized. It would be a mistake to open up our borders to these counterfeit supplies. Importation will continue expanding the growing market for counterfeit drugs. Criminals will see this as an opportunity to take advantage of unsuspecting consumers, whose health will be jeopardized by these counterfeiters.

Aside from safety concerns, drug importation will threaten future development of the most advanced medication. The Tufts Center for the Study of Drug Development reports that pharmaceutical companies spend an estimated $880 million on the development of each new medication. Such an investment must be rewarded in the marketplace with sufficient revenue to cover production and development costs. The Canadian government has a reference based pricing model that accounts only for manufacturing costs, not the research and development investment. U.S. pharmaceuticals can afford to sell medication in Canada, even with price controls, because these companies have a more natural pricing model in this country. However, if all drugs were sold under the Canadian pricing model, which importation would lead to, then pharmaceuticals would be unable to recoup the money they invested in research and development.

Opening the borders to medication from Canada and its associated price controls would stifle innovation. Medications have saved billions of dollars in other health care costs because cutting edge drugs have replaced surgery in many specialties. Studies show that an $18 investment in new medicine saves approximately $71 in other healthcare costs. Over the last ten years, pharmaceutical companies invested $200 billion in the development of new drugs. That means the pharmaceutical industry has saved our country nearly $800 billion in other healthcare costs. Americans spent $162 billion on prescription drugs in 2002. Politicians often use numbers like this to criticize the pharmaceutical industry. However, this number ignores the cost-savings that has happened because of the innovative medication developed by the pharmaceutical industry. The incentive for innovation will be removed if importation is allowed. Importation also would destroy the market that creates incentives for companies to continue developing life-saving drugs. The result will be long-term devastation for an industry that has helped make our health care system the best in the world.

We understand there are access and affordability problems for millions of Americans. However, the pharmaceutical industry provides billions of dollars to help those without health insurance have access to medication. Even so, these companies must continue working with governments and doctors to provide better access for their life-saving drugs. Even though access problems remain, the Medicare Modernization Act will improve this situation. However, it's not being implemented until 2006. This reform program must be given time for proper implementation.

In the last ten years, medication breakthroughs have transformed treatment for people with HIV, AIDS, Parkinson's disease, Rheumatoid Arthritis, Alzheimer's disease, Schizophrenia, Diabetes, High Blood Pressure, High Cholesterol and many others. Between 1993 and 2003, Americans obtained 363 new medicines, biologics, and vaccines approved by the FDA to prevent or treat more than 150 diseases. The future development of successful medications depends on having a system that rewards investment and creates an environment of innovation. Importation will threaten an industry that has transformed the lives of tens of millions of Americans. And it could jeopardize the safety of the drug supply and the health of Americans who depend on the pharmaceutical industry for their survival. Allowing price controls and importation are tantamount to performing major surgery on patient who needs only a few stitches. And the surgery being prescribed will not solve the problem. It will destroy this industry.

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