Momentum Builds for Law to Permit Rx Imports--March 2009

A bipartisan group of senators has introduced legislation that would allow US-licensed pharmacies and drug wholesalers to import FDA-approved medications from specified countries.

The Pharmaceutical Market Access and Drug Safety Act would permit drug importation from Canada, Europe, Australia, New Zealand, and Japan. The bill contains safeguards to prohibit counterfeiting or any other practices that would put patients at risk, and applies only to FDA-approved prescription drugs produced in FDA-approved plants from countries with comparable safety standards.

The Congressional Budget Office estimates the bill would save Americans $50 billion over the next decade. The sponsors said the bill would allow Americans to benefit from prices in these countries, which are 35% to 55% lower than in the United States, while still enabling them to receive medications at their local pharmacy.

The Pharmaceutical Research and Manufacturers of America (PhRMA) said this is not the time for the FDA to move forward with Rx drug importation, however, citing the need to strengthen the agency’s overseas inspections program first, as well as the threat posed by dangerous and counterfeit products crossing the nation’s borders.

“If the recent recall of foreign drug products has taught us anything, it is that Congress must better equip and fully fund the FDA so that it has the resources to do its job. The safety and integrity of our nation’s drug supply system will be at even greater risk if prescription drug importation becomes a reality,” said Ken Johnson, PhRMA senior vice president. “We should not pursue policies that could expose Americans to substandard drug products.”

Sens Byron Dorgan (D, ND), Olympia Snowe (R, ME), John McCain (R, AZ), and Debbie Stabenow (D, MI) are the bill’s sponsors. Sens Dorgan and Snowe introduced a similar measure in the last session of Congress. President Barack Obama’s 2010 budget proposal expresses support for the FDA efforts to allow Americans to purchase safe and effective drugs from other countries.

“US consumers are paying the highest prices in the world for prescription drugs, and that’s unfair,” noted Sen Dorgan. By allowing access to identical, less expensive, FDA-approved prescription drugs, we will be providing some relief to the American consumers, and force pharmaceutical companies to reprice their prescription drugs here in the United States.”

For other articles in this issue, see:

Officials Promote Responsible Antibiotic Use

Rx Information for Patients: Too Much, Not Enough, or Just Plain Inconsistent?

Patient Focus Behind Awareness Campaign