It reads like a John Grisham novel, if you can get past the regulatory language.
Rep. Henry Waxman’s, Committee on Oversight and Government Reform’s report on dissent within the Food and Drug Administration (FDA) offers a real-life view of the internal wrangling of the agency as it pushed toward pre-emption in recent years.
And it helps explains the argument that drug maker Wyeth will make to the U.S. Supreme Court on Monday.
Under the Bush administration, the FDA rewrote drug labeling rules in its 2006 preamble, that favors preemption, and again in 2008 to restrict the ability of manufacturers to disclose new safety risks without prior FDA approval.
The theory of pre-emption is that the FDA's standards for the safety and labeling of drugs is supreme and cannot be challenged by individuals injured by dangerous drugs or insufficient labels. Many call it blanket immunity for corporations.
Contained in the committee report are internal FDA emails showing that key and high-ranking FDA career officials objected to the FDA's assurances it alone could ensure safety. That was a “false assumption” and “naïve to what actually occurs in practice” and a “gross overstatement”. Their objections were overridden.
How strong was the tide of pre-emption within the FDA in recent years? It came all the way from the top, specifically the White House.
In the report, an October 28, 2005 email from Rachel Behrman, Deputy Director of the Center for Drug Evaluation and Research (CDER), says, “We discussed the cbe issue with Sheldon Bradshaw, who stated unequivocally that without the CBE language, the rule will not go forward (this is per the White House.)”
CBE language refers to “changes being effected”.
“Changes being effected” or CBE rules and the FDA preamble have become the cornerstone of the drug industry preemption argument that promises the FDA has the ability to “carefully control” drug labeling.
But on August 6, 2003, Dr. John Jenkins, with the Center for Drug Evaluation and Research (CDER), the new drug review section, disagrees with the additions especially the wording that “we precisely control” the content and format of package inserts or warning labels.
“Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up to date in a real time basis. We know that such an assumption is false. “
Dr. Jenkins says many drug labels are out-of-date and contain incorrect information about overdoses.
“It is unwise to suggest that FDA approval labeling is always up to date and always contains a full and complete listing of all pertinent risk information.”
Dr Jenkins said even if the drug makers want to identify new risks after approval of the drug, there will be a delay in proving consumers with up-to-date information on the bottle, the PDR (physician’s desk reference) or in printed materials.
Dr Jenkins says in a comment to Jane Axelrad, Associate Director for Policy in the CDER, “I am not so comfortable with the whole argument in the document about preempting state liability cases against a manufacturer for ‘failure to warn” cases. I’m not sure why this falls within FDA’s purview (are there any other examples of where FDA has promulgated regulations based primarily on a desire to protect sponsors from liability?) and I think the whole argument that liability concerns drive inaccurate labeling is false and misleading.”
His arguments fell on deaf ears, especially the FDA Chief Counsel at the time, Daniel Troy who authored and pressed for the preamble language to the 2006 ruling.
IMAGE SOURCE: Daniel Troy appearing on CBS
US News reported on Troy in this 2003 story, “Mr. Outside Moves Inside.”
Troy, a Washington lawyer and former clerk to Robert Bork, took the side of tobacco and pharmaceutical companies against the FDA before becoming chief counsel.
His was a political appointment in 2001 by President George W. Bush.
Troy resigned from the FDA in November 2004 amid controversy that he was conferring with Pfizer, among other drug companies. A former FDA official says in the article that Mr. Troy has been “as receptive to industry as any general counsel has ever been,” and he helped pave the way for the pre-emption agenda.
Returning to work in a Washington law firm, Troy joined GlaxoSmithKline as general counsel just last month.
What does this all mean for consumers and drug safety?
The 2006 rule in the federal register, drug manufacturers could no longer add information to the highlighted section of the label without FDA approval, a shift in authority for the pharmaceutical companies that previously could change a label at will.
In 2008, the language was strengthened. There had to be new evidence of a drug’s harm before a company could apply for a label change. Without a causal association, manufacturers no longer had the responsibility of early notification - they could defer to the FDA’s authority
In essence, under the rule changes, drug makers lost their independent authority to change their labels with stricter warnings.
Connect the Dots
According to Rep. Waxman’s report, in 2007 the FDA received two requests from drug makers who wanted to add safety information about important new risks to their drug labels.
GlaxoSmithKline (GSK), wanted to add information about its drug, Tykerb, and its link to abnormal scar tissue growth in the lungs of people taking the drug for advanced breast cancer. The other drug was Levaquin by Johnson and Johnson, used as an antibiotic. J & J wanted to strengthen the warning label about liver damage.
In both instances, under the new rules, the drug makers were initially prevented from updating their own drug labels to include the stronger warning.
In the Diana Levine case before the U.S. Supreme Court Monday, FDA scientists say they understood the risks of Phenergan, which caused Diana Levine to eventually lose her arm, but the drug failed to carry the specific warning.
Levine sued Wyeth after she lost her right arm below the elbow following an IV injection of the drug Phenergan which accidentally punctured an artery causing gangrene. Levine, a musician, argued that the company had a duty to warn consumers that such injections could have devastating consequences. In a Vermont jury trial she was awarded nearly $7 million.
Wyeth appealed, arguing a state court cannot overrule the FDA's judgment on label warnings and that a failure to warn consumers should be pre-empted. #