The Illness Department

Lost in the frenzied discussion about who is winning the lottery for a flu shot and how much price gouging is going on for the remaining vials is the question of how much George W. Bush's politicization of the Food and Drug Administration (FDA) played in creating this crisis.

Over the past four years, the agency has been largely taken over by free-market ideologues and officials with close ties to regulated industry. Key Bush administration appointees at the FDA include acting FDA Commissioner Lester Crawford, who worked for the food manufacturers; an assistant legislative commissioner who worked for the biotechnology industry; and an acting deputy commissioner of policy who worked for the chemical industry. But perhaps most important in bringing the FDA into a cozy relationship with the drug industry has been its chief counsel, Daniel Troy.

With Troy's appointment, the agency's top legal post went -- for the first time in decades -- from being run by a civil servant to being run by a political appointee. Troy, a staunch free-market ideologue and a leading member of the Federalist Society, clerked for one of the nation's most conservative judges, Robert Bork. In the 1990s, before coming to the FDA, Troy represented a major tobacco company, Brown & Williamson Tobacco Corp., and helped win a Supreme Court ruling against FDA oversight of tobacco. He also did legal work for Pfizer and filed legal briefs against FDA oversight of drugmakers' off-label marketing of medicines. With the FDA operating under an acting commissioner during much of Bush's tenure, Troy has wielded enormous power.

Under his guidance, the FDA has filed legal briefs asking courts to side with drugmakers and device manufacturers against plaintiffs. In fact, Troy urged hundreds of drug-company lawyers, at a meeting last December, to suggest other lawsuits that the FDA could become involved with.

In March 2002, Troy launched another dramatic initiative, taking away from field offices the responsibility for issuing warning letters to companies, requiring them to be screened first by the general counsel's office. If the FDA finds problems after inspecting a manufacturing site, it can, at its discretion, issue a warning letter telling the company what it must do to comply with the law if it doesn't want to face penalties. After Troy's centralization of warning letters, the number issued dropped dramatically, according to John Scharmann, consulting editor at FDA Webview, an online FDA-watch newsletter, and former head of the FDA's Denver district office.

At the same time, the FDA announced that it was revamping how it assessed the quality of manufacturing facilities. After a product is approved, the FDA must, by law, inspect a plant every two years. If problems are found, the FDA must decide whether (and when) to re-inspect or simply to meet with a firm or verify it has made the necessary corrections.

In the late 1990s, the FDA had strengthened its inspection of facilities that made biologics, particularly vaccines. Many of the standards that it had used for chemical drugs were for the first time applied to these other products. Inspections lengthened, inspection teams were larger, standards were more extensive. The focus was less on purely scientific issues and more on specific cleaning and quality-control procedures. Two vaccine manufacturers were found to have major problems and withdrew from the vaccine business.

When the Bush administration came in, however, it launched a new approach, termed "risk-based," to inspections. Rather than expand FDA oversight overall, the agency decided to concentrate on select products, processes, and issues. "In a risk-based approach," says William Vodra, who has served as associate chief counsel at the FDA and is now a partner at the Arnold & Porter law firm, "you pick the things with the highest risk and go after that." At the same time, FDA budget resources have been squeezed. But new laws prohibit money from coming out of such things as drug-review procedures, and "some kinds of inspections" may have suffered, Vodra notes.

So what does this have to do with the current flu crisis, which was triggered when fears about possible contamination led British regulators to shut down a plant in England where Chiron Corporation was to have produced half of U.S. flu vaccine needs?

"Was the agency not aggressive enough with Chiron to fix the problem, or did they say, 'These problems are not important,' or, 'We don't have the resources to fix it'?" questions a Senate Democratic staffer.

That is what Senator Edward Kennedy and Representative Henry Waxman are trying to find out. They have requested that the FDA provide documents on what it did after it found, back in June 2003, that Chiron had, according to The Wall Street Journal, "systemic quality-control issues." And they want materials on FDA actions after August 2004, when the FDA learned that there were contamination problems at the Chiron plant. Waxman says that even after Chiron announced a delay in releasing flu vaccine, the FDA didn't do a full inspection. Instead, as Crawford stated, "We at FDA were waiting for Chiron's report to determine if further action, such as on-site inspection, was needed." The British, however, not only sent a team to the plant and identified serious problems, but, says Alison Langley, senior press officer for public health desk at Britain's Department of Health, "developed contingency plans" to get vaccine supplies from elsewhere if needed.

On October 26, Waxman charged that the FDA was deliberately withholding these documents until after the election. While Crawford wrote four days prior that he could not comply with the congressional requests because staffers were too busy trying to find extra vials of vaccine, Waxman said that communications he received from within the FDA indicated that the documents were already sent to Crawford's office and awaiting release.

So the question is what did FDA officials know, when did they know it, and what did they do about it? It looks like the Bush administration wants us to wait until after the election to find out.

Barbara T. Dreyfuss is a freelance writer based in Virginia.