About a month ago, I knocked a Page One New York Times story titled "At F.D.A., Strong Drug Ties and Less Monitoring." The magic of the Internet being what it is, Times Executive Editor Bill Keller e-mailed a detailed defense of his reporter's piece to me at my email@example.com account the next day. The magic of the Internet being what it is, I never received it—or more likely, the spam filter tossed Keller's message into my bottomless junk mail pile.
This week, Keller remailed his note, I received it and am happy to publish it and respond.
From: Bill Keller
Date: Jan. 3, 2005
If our FDA story failed to make its point clearly to a careful reader such as yourself, then that is certainly a strike against it. Maybe I was just better caffeinated than you, but I found the import of the story pretty clear, and it bore little relation to the version you so cutely satirized.
First, I think it's unfair to categorize it in the "underfunded agency" genre. The FDA may be underfunded or it may be overfunded, but the point of this story was that its regulatory mission was seriously distorted by a drastic reallocation of priorities under the 1992 formula—away from monitoring the safety of drugs already on the market and to the accelerated testing of drugs vying for market approval. The story is not about whether the FDA has enough, but about how it spends what it's got. You at least imply that this is one of those stories in which an agency collaborates in poor-poor-me accounts of the horrors that have befallen the public interest as a result of cuts to its budget. The FDA seemed to understand that this was not one of those stories; it refused to cooperate in even a wink-wink way, and declined to give us the numbers the reporter, Gardiner Harris, sought. Gardiner had to calculate the pre- and post-approval numbers from several different sources, which is probably one reason nobody else has done this piece.
Second, you are right that the case study we used to illustrate the point, Seldane, is a bit more complicated than our summary conveys. Your best point is that it took even longer for the (fully funded) FDA to get Seldane off the market than it did for the (not fully funded) FDA to stop Vioxx.
But the point of using Seldane was to show that back in the day the FDA, once it had questions about a product, had mechanisms in place to answer those questions rather quickly. Now it does not. Now it depends entirely on voluntary efforts by the drug makers to discover safety issues regarding drugs that have been approved. That is a fundamental change in the way the FDA operates, and not widely understood. Seldane happens to illustrate that point. It is true [the] FDA was unable to force Seldane off the market, but it was able to issue a black-box warning, and—contrary to what you suggest—it had a devastating effect on sales of the drug. At least Seldane's makers and their market-share-conscious stockholders thought so. Claritin quickly surpassed Seldane to become the biggest seller in the category.
Third, you fault the "subdued hysteria" of those who say fast-tracking of drugs produced an avalanche of dangerous new medicines. That's a fair point—except that our article carefully does NOT make that claim. You've made us into a straw man. Some 2,000 words into Gardiner's piece, there are exactly four paragraphs on the debate over whether fast-tracking lets bad drugs into the marketplace. Three of those paragraphs cite government and industry officials explaining that this has not happened. The point of those four paragraphs was simply to say: most of what you read on regulation of drugs focuses on this inconclusive debate about fast-tracking, but hardly anyone writes about the inadequacies of the system for policing drugs AFTER they get to market. Which is exactly why we thought the issue merited a full page of our paper, and why I think your caricature of it is wrong.
I hope your readers will pour coffee, click the link, and read the story for themselves.
Sorry about the screw-up. I've added your name to my "trusted senders" list so my e-mail program will never mistake your words for spam again.
Let me field your objections one by one.
You reject my characterization of the Times story as an underfunded agency genre piece, insisting that it's really about the "drastic reallocation of priorities under the 1992 formula. …"
I disagree on a couple of fronts.
To begin with, the formula you refer to was specifically set up to prevent "reallocation." As your piece reports, the pharmaceutical industry worried that if it started paying the FDA millions in user fees to speed new-drug review, the agency would merely dump the money into its general budget. The formula committed the government to spending the user fees on new-drug review only and to continue supporting new-drug review with taxpayer funds at 1992 (and then later 1997) levels—in other words, it blocked the FDA from reallocating priorities. As the Times article states, "the industry promised to give the agency millions—in the 2003 fiscal year, $200 million—but only if the agency spent a specified level of money on new drug approvals."