FDA’s Troy ‘was a pre-emption guru’

The American Association for Justice said federal agency documents it obtained through Freedom of Information Act requests show that former FDA chief counsel Daniel Troy was responsible for the Bush administration’s efforts to pre-empt state liability claims in many federal agencies. 

The AAJ issued a report, Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability, that details what it terms an “unprecedented campaign to negate the effect of state laws that protect consumers and injured workers —in effect granting immunity to irresponsible corporations.”

The report says the administration instructed federal agencies to insert pre-emption language into the preambles of proposed and final rules. 

The AAJ said the effort began at the FDA with Troy, a former drug company lawyer and lobbyist who became the agency’s chief counsel in 2001 and effectively ran the agency for a year until a commissioner was appointed. While the FDA had been operating under a “presumption against pre-emption,” Troy sent it in the opposite direction, initially filing briefs on behalf of drug companies. 

Other agencies began copying the amicus approach, the AAJ said, but then the strategy changed as Troy found that intervening on a case-by-case basis was inefficient and put the new policy in a preamble to the January 2006 prescription drug labeling rule. 

“To date,” the AAJ reported, “seven federal agencies—many times without any opportunity for public comment—have issued over 60 rules with preemption language in the preamble to the rule.” The report also detailed instances of what the AAJ said are “cozy relationships between federal officials and the industries they regulate.”  It cites e-mails on meetings held between PhRMA, drug company lawyers and Sheldon Bradshaw, who succeeded Troy at the FDA. Less than six months after such a meeting, AAJ said, the FDA released its final physician labeling rule with complete immunity pre-emption language in the preamble.