Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
However, the CDER leadership refused to accept the conclusion of regulators around the world and its own advisory committee that Avandia is hazardous.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
In Congressional testimony, CDER officials acknowledged that FDA statisticians had confirmed our findings, reporting a 40% increase in the risk of heart attack.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
Since 2006, CDER has expended considerable taxpayer dollars trying to absolve itself of responsibility for this inexplicable error in judgment that cost many lives.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
In 2010, CDER and GSK saw an opportunity clear Avandia of any cardiovascular hazard and scheduled an FDA Advisory Committee meeting to exonerate the drug.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
Because RECORD did not confirm a cardiovascular hazard, key senior CDER leaders saw this as an ideal opportunity to absolve themselves of culpability in the Avandia scandal.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
If CDER is allowed to re-write the history of Avandia, this vital FDA Center will continue to function as an unsupervised, self-regulating bureaucracy, accountable to no one.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
The leadership of CDER was intensely embarrassed by these revelations and furious with us for publicly challenging the safety of Avandia (and indirectly the competence and integrity of CDER).
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
If the RECORD trial was reliable, the logic goes, then the 2006 decision by CDER to conceal the risks of Avandia did not represent a dereliction of its public duty.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
And through June, CDER had approved 12 NME applications and received 15 NME applications for filing, which works out to a higher percentage of approved NME applications than in 2011 ( see this).
The most likely explanation: the leadership of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER), is seeking to avoid accountability for its role in the Avandia tragedy.
FORBES: Steven Nissen: The Hidden Agenda Behind The FDA's New Avandia Hearings
These range from microwave ovens and laser light shows to home security systems and medical imaging devices. (CDER even regulates laser pointers but not online presentation software, if ever a true risk to human health).
With CDER now over 4, 000 employees, Dr. Moscicki, in his newly established role, will join Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in providing leadership and overall direction to Center activities to ensure that we accomplish our mission most effectively.
Moreover, the lorcaserin carcinogenicity studies were also thoroughly reviewed and discussed by the Center for Drug Evaluation and Research (CDER) Executive Carcinogenicity Assessment Committee, and the results of this scientific assessment were included in the background documents provided to the committee and discussed in Agency presentations at the Advisory Committee meeting.
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