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Chiron Lets FDA Share Secret Data With British

Times Staff Writer

Chiron Corp. has agreed to let the Food and Drug Administration share confidential company data with British regulatory authorities, a step toward preventing the kind of communication breakdown that contributed to last month’s flu vaccine debacle.

The arrangement is intended to help regulators from the two countries solve contamination problems at Chiron’s vaccine factory in Liverpool, England, and ensure that it will be able to supply flu vaccine next year. The FDA announced Oct. 13 that the two governments would cooperate in a bid to enhance manufacturing standards at the plant and evaluate the scope of the bacterial contamination.

As part of that accord, Emeryville, Calif.-based Chiron has given its consent for the FDA to share with British authorities company information -- including trade secrets -- that previously would have been withheld from Britain, according to information obtained by The Times.

Chiron declined to comment.

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U.S. officials cite the cooperation as a practical way to address the difficulties at Chiron, while they also pursue a broader agreement with Britain aimed at authorizing more direct dealings and communication between the nations’ healthcare agencies.

“We want information sharing, and we’re committed to doing that through whatever means that we can,” said Lester Crawford, acting commissioner of the FDA.

However, concerns on both sides of the Atlantic that broader information sharing might jeopardize corporate secrets remains an obstacle to a broader deal with either Britain or other major U.S. trading partners.

“I don’t want other countries to have trade secrets unless they can keep them secure,” Crawford said in an interview.

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It’s not clear exactly what Chiron information would be provided to the British, although experts said it could include findings related to the company’s production methods, rather than marketing and sales information.

U.S. public health officials were caught off guard by the shutdown of Chiron’s Liverpool plant, which wiped out almost half of the U.S.’ expected vaccine supply for the current flu season.

Just how much American regulators knew about the depth of the Chiron factory’s problems -- and when they knew it -- remains a central focus of lawmakers who are planning a hearing next week on the flu vaccine shortage. Congressional staffers are reviewing an array of materials related to the FDA’s oversight of the vaccine factory, in an effort to pass judgment on the agency’s performance in protecting the public.

Because of the lack of an information-sharing accord, British regulators were not allowed to pass on their findings to the FDA, including the results of a September 2004 plant inspection that preceded the shutdown.

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Soon after the closure, Crawford said he wanted to use the mess as a test case for improved communication between U.S. and foreign regulators. On Oct. 13, the FDA and the British Medicines and Healthcare Products Regulatory Agency said they would work together to examine problems at the plant and try to get it ready for next year’s flu season.

Industry observers expect renewed regulatory attention to international cooperation, particularly information sharing. Efforts to make such deals across national boundaries have often been slowed by the inherent technical challenges -- regulators may not have the same testing procedures or safety standards -- as well as concerns about protecting trade secrets.

At the same time, there is growing precedent for such accords. Britain, for example, shares broad amounts of regulatory information related to healthcare and pharmaceuticals within Europe, and with nations such as Australia, New Zealand, Canada and Japan.

The FDA has been trying since 2002 to develop its own information-sharing arrangements with other countries, covering certain confidential information, including investigative and other regulatory data but not trade secrets.

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It took a step in that direction in September 2003, reaching an agreement with the European Medicines Agency, although that arrangement is not binding on other individual European countries.


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