Where Were the FDA's DTC Monitors?

The lead stories in the Sunday New York Times and Washington Post both focused on the Food and Drug Administration's inability to monitor imported drugs, especially from India and China. It's an important issue. Hundreds of people could get hurt or killed if a dangerous batch of drugs slip into the U.S., as recently happened in Panama. We need more inspectors, and the FDA should be given the money to hire them.

But is this threat from imports from China and India comparable to the threat posed by the illegal drug advertising that fills our airwaves, magazines and newspapers every day? I could not help but note the comments from Indian generic manufacturers that trade economics as much as safety were at the heart of these concerns.

John Dingell (D-MI), chairman of the House Energy and Commerce Committee and usually a vociferous trade hawk, doesn't think so. Last Friday, he sent a letter to Michael Leavitt, the head of the Health and Human Services department (the FDA's parent agency), demanding to know why the FDA never cracked down on ads for the anti-anemia drugs Procrit and Aranesp, which claim to make their users ready for chemotherapy because they make patients feel better.

The problem with that claim is that the FDA has never approved the drugs for that purpose. Every time oncologists used them to raise red blood cell counts above the FDA-approved level for correcting anemia (about 90 percent of normal), they were prescribing them "off label." You can't advertise a drug for other than its approved purpose -- at least I always thought that was the case. So weren't all those ads, ipso facto, illegal?

Hundreds of thousands of cancer patients were given these drugs off-label. Hundreds, perhaps thousands, died unnecessarily because of what we now know to be their dangerous side effects: when used to raise red blood cell counts to near normal levels, they raise the incidence of sudden death from heart attacks, strokes and other cardiovascular events.

Dingell is seeking all correspondence between the FDA and the companies regarding oversight of the ads. What if the agency responds that it has nothing to send to the inquiring House investigators? If you think the FDA is short-staffed for monitoring imports, do a head count over in the office that monitors DTC ads.

It will be interesting to see what the House Energy and Commerce committee does when it marks up the FDA reform bill, starting tomorrow. The drug industry and its allies in the broadcast and print media industries have been engaged in a full court press to avoid further restrictions on direct-to-consumer ads. They won in the Senate. Will they get away with it in the House, too?