Déjà Flu

Once again the country is facing a flu vaccine shortage, but it has gotten little attention from the Bush administration. Health care facilities, schools, and supermarkets are canceling flu vaccine clinics in Arizona, California, Texas, New York, D.C., and elsewhere. As Hillary Clinton noted on November 10, the American Lung Association's Flu Clinic Locator Web site has been rendered almost useless because so many clinics have been canceled around the country.

Last week administration officials started downplaying the shortage and assuring people that there will be adequate supplies eventually. Centers for Disease Control Director Julie Gerberding claimed the shortage would be temporary; she said it may in part have been triggered by greater demand this year than last, but admitted she had no data to support that. Gerberding announced that 71 million doses had been distributed as of November 10, with a total of 81 million expected by the end of November. The good news, she said, is that so far there have been relatively few flu outbreaks this season.

Officials acknowledge that the current shortage may be partly caused by troubles at the same Chiron Corporation plant that triggered last year's flu vaccine crisis, noting that “providers and distributors who ordered from Chiron will receive substantially less vaccine than they had ordered.” Major manufacturing problems still plague the facility,
which was shut down by British health officials last October after they found serious production problems and contaminated vaccine.

British regulators reopened the plant in March, and in April the company predicted it would manufacture 25 million to 30 million doses of vaccine this year. But in June it lowered this estimate to between 18 million and 26 million doses. On October 17 the company admitted that production would be much lower than 18 million doses, but would not give a more specific estimate.

The manufacturing problems that triggered last year's shutdown of the plant were known to FDA officials at least as far back as 2003, when the FDA inspected the facility. If the FDA had forced changes at the plant back then, it might have been ready for full production this flu season.

But the FDA didn't force Chiron to correct its problems in 2003 because its oversight powers had been seriously weakened by the FDA's then–chief counsel, Daniel Troy. Before coming to the FDA, Troy, the first political appointee to hold that post, had spent years suing the agency in an effort to curb its authority.

One of the first actions Troy took after becoming the FDA's top lawyer in August 2001 was to require that key issues regarding oversight of manufacturing facilities be channeled through his office. That meant that any warning letters, threats of legal action against companies that did not fix problems, had to be cleared by Troy. When FDA inspectors found unsafe drugs and wanted to seize them, Troy's office would decide whether or not they could.

A report earlier this year by Representative Henry Waxman shows that once Troy began to exert control over the FDA's manufacturing oversight, official FDA policing actions decreased markedly. Between 1999 and 2001, the FDA took action against 36 companies making biological products such as vaccines; in the next three years, it acted against only six firms.

FDA inspectors and those who enforce compliance with FDA rules became very demoralized by Troy's policies. “People work in an agency like the FDA not because they are going to make a lot of money but because they think they can make a difference,” says William Hubbard, who retired earlier this year from his position as Associate Commissioner for Policy and Planning after 32 years at FDA. “So when a public health problem comes up they are going to look at what solutions we have, what's our tool box. If using that full toolbox is viewed as too much power, well, that is demoralizing, insulting, and saying to people you can't solve the problem. And if you can't solve the problem, why be here?”

Officials who had spent months preparing to take companies to court to force them to meet standards and obey requirements were told they could not take action, FDA veterans say. Troy's office would call FDA compliance officials and tell them to withdraw a proposed action against a company because it was not going to be approved. “A lot less got submitted as warning letters because they knew they would get that review and a lot less got approved after they were submitted,” says a former inspector. “It definitely had a chilling effect.”

When FDA inspectors did a routine inspection of Chiron's flu vaccine plant in 2003, they found significant manufacturing problems that could affect the quality and sterility of products which required immediate correction. These problems were definitely related to the contamination found a year later, former FDA officials say, and were serious enough that the resulting contamination should not have been a surprise.

But when the inspectors wanted to issue a warning letter to the company, an action that would have told the company it urgently needed to correct problems or face the prospect of the FDA shutting down all manufacturing at the plant and seizing any existing product, they were not allowed to do so. Such a warning would have required not only immediate corrective action by the company, but another FDA inspection in a year to make sure the problems had been resolved.

Instead, senior officials at headquarters decided not to take official action. The company was told it could handle corrections on a voluntary basis, and an FDA inspection was not scheduled for two years.

It appears that Troy's office wasn't officially consulted on whether to issue a warning letter in this case; the decision was made lower down the line. But with his views on regulatory action clear, he did not need to be directly involved, say former officials involved with this issue. He had already decimated FDA oversight.

Barbara T. Dreyfuss is a freelance writer in Alexandria, VA.