GSK slack in updating Avandia data, FDA says

WASHINGTON -- Federal regulators issued a warning to GlaxoSmithKline for not reporting safety results on its diabetes pill Avandia, which received a prominent warning label last year.

The Food and Drug Administration said that between 2001 and 2007 the drug maker did not annually update the agency on at least 10 ongoing studies of Avandia, as required by regulations.

The agency acknowledges that information from the studies was disclosed in other notices, but the omissions "are serious and may be symptomatic of underlying post-market reporting failures."

The FDA said it had no record of nine other studies until September, when GSK provided a corrected version of its 2007 update on Avandia.

"We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are under way," GSK's Chief Medical Officer Ronald Krall said.

Avandia received a black box warning, the most serious a drug can carry, in November. The labeling alerts doctors and patients that the drug could increase the risk of heart attacks, though the evidence is inconclusive.

GSK has agreed to the FDA's demand for a major study directly assessing Avandia's heart effects, but it won't be complete until 2014.

The labeling change followed several high-profile congressional hearings at which FDA and GSK were criticized for not disclosing the drug's potential risks earlier.

FDA inspectors uncovered the reporting problems at GSK's U.S. headquarters in Research Triangle Park, during visits August through November. The agency notes that GSK tried to address inspectors' concerns in a December letter, but regulators said the response was inadequate because it did not explain how GSK would stop the problems from happening again.

In at least two cases, GSK said it didn't turn over studies because they were conducted at the request of European regulators, not the FDA. The European excuse didn't satisfy FDA or consumer advocates

"The FDA can't make regulatory decisions on a drug unless companies promptly disclose all information relating to safety -- it doesn't matter who asked for it," said Dr. Sidney Wolfe of Public Citizen, a critic of both the drug industry and its regulators.

Sales of Avandia fell 22 percent last year to $2.4 billion amid safety concerns. The company's shares have fallen nearly 20 percent from last year.

GSK shares fell $1.79 Tuesday to close at $43.24.

The warning letter may also have pressured shares of Pozen, a Chapel Hill drug developer that has been collaborating with GSK on the migraine treatment Treximet.

Analysts attributed an 8 percent decline in Pozen stock, which closed at $10.70, to concerns that the government warning could delay approval of Treximet, which has failed twice in FDA reviews.

Pozen spokesman Fran Barsky said the warning letter shouldn't have any effect on Treximet, because GSK's name isn't on the regulatory paperwork. "It has been ours all along," he said.

(Staff writer Sabine Vollmer contributed to this report.)