Straight from the Horse’s Mouth

Yesterday's congressional hearing on the FDA's ability to guarantee the safety of our country's drug supply sounded another alarm that real consumer-protection measures need to be put in place that focus on patient safety.

Let's hope Congress doesn't hit the snooze button again.

It's been 9 years since the Government Accountability Office (GAO) last issued a report to Congress that highlighted the problems the FDA has had in its foreign drug inspection program.

But yesterday, Marcia Cross, director of healthcare for the GAO, painted an even more dismal picture. The GAO report and other testifying witnesses cited example after example of the holes in the FDA's efforts. Since an estimated 80% of the active pharmaceutical ingredients used to make drugs here are imported and another estimated 40% of finished drugs are made abroad, the GAO's findings are especially unsettling. Some highlights:

• Two-thirds of the foreign drug manufacturers subject to FDA inspection may never have been visited by FDA inspectors.
• Foreign drug manufacturers are only inspected once every 13 years – if ever.
• Due to scheduling pressures, foreign inspections can last only 2-3 days, whereas domestic inspections last a week to a month.
• The FDA's databases don't have accurate records as to what companies export drugs into the U.S. or whether they have been inspected.
• The FDA inspectors must provide months of notice to foreign firms that they will be inspected, compared with unannounced inspections in the U.S.
• FDA inspectors aren't provided with translators, leaving them to rely on English-speaking firm employees during their inspections.
• There is no requirement that the FDA conduct foreign inspections with any regularity, compared with every 2 years in the U.S.
• The estimated amount of FDA-responsible imports doubles every 5 years.
• The number of FDA inspectors will drop from 149 in 2002 to only 102 by 2008.

China is the primary country involved in drug manufacture. Rep. John Dingell (D-MI), chairman of the House panel looking into the matter, notes that China alone has 700 firms making drug products for the U.S., but the FDA has the resources to conduct only 20 inspections annually for this country.

But the unregulated Chinese firms are the source of much of the fake medicine throughout the world sold in markets and over the Internet. The World Health Organization estimates that 10% of all drugs are now counterfeit and 50% of drugs sold online are fake.

As supply chains become increasingly global, it's easier than ever for counterfeiters using these foreign materials of questionable quality to penetrate the U.S. market.

I'm encouraged by the congressional focus on this issue. But I hope another nine years doesn't pass before the FDA is given the resources to screen foreign-sourced drugs to ensure patient safety.

In the meantime, consumers must protect themselves and be aware of the risks they take in purchasing medicines from unknown and unverified sources and particularly questionable websites.

One way to do this is to click here and sign up for the SafeMeds email alerts of government counterfeit drug warnings. We'll talk about other tools in future discussions.