Expert Reports From YAZ / Yasmin Lawsuits Will Not Be Considered Because Submitted After Deadline Set By FDA

(Posted by Tom Lamb at DrugInjuryWatch.com)

_____________________________________________________________________

UPDATE:  "Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says" (12/8/11, Bloomberg)

(12/12/11)

_____________________________________________________________________

In October 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included new findings about the safety of oral contraceptives containing drospirenone (DRSP), such as Bayer's YAZ and Yasmin pills.

At the same time the FDA announced that those new findings would be presented and discussed at a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.

On December 6, 2011 the FDA made available the following background material for this YAZ / Yasmin meeting:

• Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Bayer Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• FDA Briefing Information for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Drug Safety and Risk Management Advisory Committee Roster for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Advisory Committee for Reproductive Health Drugs Committee Roster for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee
• Draft Questions for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

______________________________________________________________________________

YAZ / Yasmin / Ocella / Beyaz / Safyral
Free Case Evaluation
Strictly Confidential, No Obligation.

______________________________________________________________________________

Somewhat related to this FDA drospirenone (DRSP) safety inquiry is a December 6, 2011 Bloomberg news article, "Bayer Withheld Yasmin Data From U.S., Former Agency Chief Says", which, in relevant part, informed:

David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn’t include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin’s safety provided to the agency.

The report also didn’t include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft….

Kessler’s report and four other expert opinions were released yesterday by lawyers representing former users of Bayer’s Yasmin family of contraceptives. The experts were paid by the plaintiffs’ lawyers, who submitted the reports to the FDA….

According to this Bloomberg article, however, these YAZ / Yasmin litigation expert reports will not be considered by the advisory committees at the December 8, 2011 FDA meeting because the deadline for all written submissions was November 23, 2011.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation – Free & Confidential