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Opinion

Drug Importation Is Risky Business

If there’s one issue that both the Democratic and the Republican parties agree on, it’s the need to reduce the price of prescription drugs. While politicians and experts do not agree on how to do it, they all agree it needs to be done.

To address high drug prices, one of the ideas that has been advanced for many years — and has recently gained added currency as drug price reduction has become more of a political issue — is to permit the importation of drugs from other countries, especially Canada. Many U.S. residents, especially those in the border states, now regularly cross the border and get their prescriptions filled in Canadian or Mexican pharmacies at lower prices than they pay in the United States. This is because drug prices in Canada and Mexico tend to be lower because of government price controls.

However, large-scale imports from Canada or any other country is not the solution. We need to come up with solutions within our own borders.

The Food and Drug Administration, as a matter of long-standing policy, has not taken enforcement action against individual consumers who bring back into the United States a personal supply of drugs. However, the FDA has consistently opposed the importation of large amounts of a drug unless there is documentation about the source and quality of the products, as well as assurances that the products were made in an FDA-inspected facility and meet quality standards.

Which brings the debate to where we are today: once again discussing the idea of allowing commercial companies and state governments to import prescription drugs from Canada and sell them at lower prices to U.S. consumers. As an example of how far this debate has come, just recently, President Donald Trump directed Health and Human Services Secretary Alex Azar to work with Florida on its drug importation plan.

And while the United States has never allowed large-scale importation, the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 gave the secretary of HHS the power to allow the importation of drugs. But the law provided that the secretary would have to certify that the imports would pose no risk to patients and would lead to cost-savings for U.S. patients.

In the wake of the passage of the MMA, then-HHS Secretary Tommy G. Thompson created a task force on drug importation to look at issues surrounding the questions of drug importation. The task force issued its report in December 2004, and since that report, all the HHS secretaries have followed the advice of the FDA and have not felt comfortable making this certification.

Importation would pose risks for U.S. patients and should not be federal policy. Importation is an idea that works well for some individual patients now, when the importation is done only for a small amount of a drug intended for personal use. But there is general agreement among key stakeholders that if the importation process were ramped up to commercial scale, patient safety would inevitably be at risk.

If importation from Canada were to become a large-scale program, Canada would see huge amounts of prescription drugs flooding its pharmacies from foreign manufacturing facilities for export to the United States. Canada does not have the capacity to ensure that all the drugs made overseas meet applicable quality standards, and consumers may thus be exposed to drugs that are indeed imported from Canada but are neither made in Canada nor tested by Canadian authorities for quality.

Despite the expansion of the FDA’s inspection program in overseas drug manufacturing facilities, there remain serious challenges in assuring quality. A former FDA inspector was widely quoted in the media recently for saying that FDA inspectors are struggling to keep up with foreign drug manufacturers. There has been ongoing national publicity about the dozens of recalls of generic blood pressure drugs that were imported from manufacturing plants outside the United States.

Manufacturing a prescription drug is more complex than manufacturing virtually any other product. A prescription drug must not only contain the exact amount of each ingredient, but each batch of the manufactured drug must be tested for quality, using sophisticated testing methodologies. It could be a potential danger for a patient to take a single tablet of a product that does not meet strict quality standards. There is no margin for error.  

Beyond that, an unscrupulous manufacturer can, and does, make counterfeit pills that look like the real drug. If drugs were to be imported, the number of counterfeit drugs would undoubtedly increase.

Those who advocate for a broad importation program are well-intentioned. Drug prices pose a serious problem for millions of U.S. patients who either cannot afford their needed therapies or who must make sacrifices to get their prescriptions filled. This is true even for people with good health insurance, as insurance companies continue to increase the co-pays that patients must pay at the pharmacy. Medical advances have been remarkable, but the programs that enable patients to gain affordable access to these new therapies have not kept pace.

We need to address this drug price challenge aggressively, so that no patient is denied access to a necessary medication based on inability to pay. But facilitating large-scale imports from Canada or any other country is not the solution. We need to come up with solutions within our own borders.

 

Wayne Pines is president of health care at APCO Worldwide in Washington, D.C., and he is a former associate commissioner for public affairs at the Food and Drug Administration.

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