Washington Editor

WASHINGTON - Reps. John D. Dingell (D-Mich.), chairman of the House Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, are considering "emergency" legislation to force the FDA to conduct preapproval inspections of manufacturing facilities.

The lawmakers' call for the new legislation was prompted by the revelation that the FDA had failed to inspect a Chinese plant that provides the active pharmaceutical ingredient in Baxter International Inc.'s blood-thinning agent heparin.

The FDA on Feb. 11 alerted the public about a spike in the number of serious adverse events associated with heparin, including reports of four deaths and hundreds of allergic-type reactions. Deerfield, Ill.-based Baxter agreed to temporarily halt the manufacturing of multidose vials of the drug until a cause of the adverse events was discovered.

In a Feb. 18 media briefing, Joe Famulare, deputy director of compliance at the FDA's Center for Drug Evaluation and Research, blamed the agency's failure to inspect the Chinese plant where the heparin ingredients were made on a clerical error in processing the approval application. Regulators erroneously reviewed information for a similarly named plant that had previously been inspected, Famulare told reporters.

He called the mistake an "isolated incident."

While foreign facilities that supply ingredients for medicines used in the U.S. are inspected under FDA policy prior to the approval of a product application, there is no law requiring that those inspections take place, according to the FDA.

Agency personnel told congressional staffers in interviews last week that the FDA is under no obligation to withhold approval or bar shipment of products until inspections are completed, Dingell and Stupak noted in a Feb. 21 letter to FDA Commissioner Andrew von Eschenbach.

More importantly, the lawmakers said, regulators do not consider the selling of a drug from a plant that has never been inspected to be the same as distribution of an unapproved drug. It has been Congress' understanding, Dingell and Stupak said, that the FDA must approve each step of the manufacturing process.

"If FDA has abandoned, either formally or informally, its vital preapproval inspection policy for the U.S. drug supply, this represents a troubling development that puts consumers at risk," the Michigan Democrats wrote. Preapproval inspections were put into place 20 years ago when manufacturing safety issues arose with the generic drug industry, the lawmakers noted.

"Since it appears that FDA feels free to ignore this long-standing policy, we are now considering whether such safeguard should be codified into law," Dingell and Stupak said in a statement.

The lawmakers demanded von Eschenbach provide them with clarification about the agency's current policy for preapproval inspections and to have access to certain top agency officials and the reviewers responsible for the approval of the active ingredient supplier for heparin.

In a separate letter to Department of Health and Human Services Secretary Michael O. Leavitt, the lawmakers ordered that all records related to the FDA's preapproval processes be turned over to the House committee within 24 hours.

Dingell and Stupak also asked Baxter to provide the committee with all records relating to suppliers of the active ingredients for heparin, facility inspection documents, the firm's correspondences with the FDA related to the drug, promotional and marketing materials and all reports of adverse events associated with heparin.

Government to Revamp Next Vaccines for Flu

The FDA's Vaccines and Related Biological Products Advisory Committee Thursday voted in favor of adopting a change advised earlier this month by the World Health Organization to revamp the strains selected for the 2008-2009 seasonal influenza vaccine.

The three strains chosen are H3N2/Brisbane/10, H1N1/Brisbane/59 and Type B/Florida.

Advisers and regulators missed their mark for this season's influenza vaccine by not including H3N2 in the mix. That strain now is wreaking havoc across the U.S. The current vaccine is only about 40 percent effective.

Widespread activity of influenza is being reported in 49 states, up from 44 states reported a week ago, Nancy Cox, chief of influenza at the Centers for Disease Control and Prevention (CDC), said Friday during a media briefing.

She confirmed that there have been 22 reports of influenza-related deaths among children between Dec. 24 and Feb. 10, an increase of 12 deaths from CDC's report a week earlier.

"The influenza season actually started out being primarily an H1N1 year," Cox said. "H1N1 dominated through December into the first part of January when we had a switch to H3N2 viruses."

About 83 percent of the viruses currently circulating in the U.S. are influenza A, 63 percent of which are the H3N2 strain and 37 percent the H1N1 strain, Cox said, adding that less than 16 percent are influenza B.

"So we really had a transition from what was predominantly a fairly mild influenza season with H1N1 viruses and B circulating and H3N2 to a lesser extent to a situation where H3N2 viruses are predominating overall," she said.

Cox said it was difficult to estimate now whether vaccine manufacturers will be able to produce enough vaccine in time to meet the demands of the 2008-2009 season.

"There are a number of elements within vaccine production that make the situation a little unpredictable," she said.