Should We Keep Our Drug-safety Record The World’s Best?

When it comes to prescription drug safety, the United States has the world’s best track record.

A system involving America’s pharmaceutical research companies and strong oversight by the U.S. Food and Drug Administration (FDA) protects public health and helps ensure that drugs produced and sold in this country are safe for patients and do what they are supposed to do.

It’s no accident the United States has such a great record. Before a medicine is approved, it goes through extensive lab testing, many clinical trials and a rigorous FDA review, spanning 10 to 15 years on average. In fact, for every 5,000 compounds that could become drugs, only one is ever approved for sale.

The FDA devotes half its pharmaceutical review budget to safety issues. FDA regulators thoroughly examine tens of thousands of pages of scientific data on each new medicine, carefully weighing the benefits and risks.

The U.S. Senate recently improved and voted to reauthorize the Prescription Drug User Fee Act (PDUFA). The application fees charged by the FDA under this act provide resources, including staff, so the agency can review new medicines more efficiently while maintaining its stringent safety and efficacy standards. The Act still has to pass the House and be signed by the president.

The system that keeps us safe, however, may be under threat from drugs imported from countries where safety regulations are scant at best and often nonexistent. A rising epidemic of counterfeit medicines produced in developing countries has already resulted in countless deaths around the world.

Some drugs that may appear to be safe and made by reputable companies are actually counterfeit and originate in countries with lax oversight and regulations. Some counterfeits look so real only a lab can determine whether the contents are what they are supposed to be.

Even the Canadian government has said it cannot guarantee the true origin or the contents of the drugs sold on what claim to be Canadian Web sites.