December 27, 2006.
By Evelyn Pringle
Washington, DC: In hindsight, its now more than apparent that Daniel Troy, who fought against stricter prescription drug laws in private practice, was appointed Chief Counsel at the FDA for one reason, to serve as Godfather in setting up a protection racket for Big Pharma.
On August 20, 2001, when President Bush made him Chief Counsel, Mr Troy became the first political appointee to ever hold that post. After he completed his dirty work of installing the policy of preemption in record time, he went back into private practice to reap the financial rewards of the protection racket by once again working directly for Big Pharma, and throwing all conflict of interest rules to the wind.
And furthermore, he obviously could care less about who knows it.
In the October 9, 2006, Legal Times, Mr Troy said, "I was also at the FDA while January's Physician Labeling Rule, which contains a statement in its preamble about the FDA's pre-emption authority, was written."
"And I now," he brags, "advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements."
His bio at the end of the article says Mr Troy is a partner in the DC office of Sidley Austin, "where he specializes in food and drug law as well as administrative litigation."
Judging by the firm's Web site, which side he represents calls for no description.
In the Times article, Mr Troy contends that private lawsuits are a great cause for concern. "There is no question," he says, "that the current product-liability environment represses innovation, limits access, increases prices, and interferes with rational prescribing decisions."
In another paper on March 31, 2006, he said that this environment has reduced the availability of drugs. "Not only are fewer drugs being researched and created," he wrote, "but also existing beneficial drugs have been removed from the market because of crippling litigation.
However, these comments completely contradict what Mr Troy said on December 15, 2003, during a lecture given to drug company attorneys telling them how to use preemption to win lawsuits against private citizens, when he specifically said that the FDA has "no good evidence" demonstrating that product liability concerns "keep good products off the market" and that he had "combed the literature" to find such evidence, but had come up empty.
In fact, during his lecture, Mr Troy told the defense attorneys to get busy and find some evidence no matter how weak, stating: "you guys really shoot yourself in the foot by not funding research to this effect. ... I'll even take anecdotal evidence and stories if you have them."
In his March 31, 2006, paper, Mr Troy says that until "an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by-state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans."
While Chief Counsel, in the midst of the Vioxx and SSRI antidepressant disasters, when it became known that the drug makers had for years concealed and manipulated studies that showed the harm caused by these drugs, instead of going after the drug makers for knowingly injuring hundreds of thousands of patients with dangerous drugs, Mr Troy devoted the majority of his time on the pubic payroll to filing briefs on behalf of pharmaceutical companies.
He spent so much money helping Big Pharma, that on July 14, 2004, Congressman Maurice Hinchey (D-NY), called for an amendment to cut funding for the FDA by $500,000 with the intention to cut the budget of Mr Troy's office.
"The FDA's Chief Counsel," Rep Hinchey said in a speech on the floor of the House of Representatives on July 14, 2004, "has wasted taxpayer money on pursuits that are undermining FDA's basic mission."
"For the first time in history," he told members of Congress, "FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers."
The cases are private, State, civil litigation cases and according to the FDA, "it has spent over 622 hours on these cases," he said.
The Congressman described what he called a pattern of collusion between the FDA and drug companies and medical device makers in three State court lawsuits.
One of Mr Troy's previous clients at the law firm, Wiley, Rein, & Fielding, was Pfizer, which in the 3 years prior to his appointment to the FDA, Mr Hinchey said, paid the firm $415,000 for services provided directly by Mr Troy.
According to the Congressman, in July of 2002, Malcolm Wheeler, an attorney for Pfizer, called Mr Troy, and requested that the FDA get involved in a lawsuit filed by a private citizen against Pfizer in California. Less than 2 months later, the FDA through the Department of Justice, which represents the FDA in court, filed a brief in support of Pfizer saying the plaintiff's claims were preempted by federal law.
In the brief, Mr Troy opposed the claim that Pfizer was required to warn that the antidepressant, Zoloft, caused suicide and noted that the FDA had considered whether such products increase the risk of suicidal thoughts and behavior and had concluded that the warning was not justified.
The brief maintained that the warning would have misbranded the drug. The court upheld the lower court's dismissal on other grounds and never addressed preemption, but from then on, Big Pharma lawyers relied on the FDA's briefs to support their preemption arguments in other cases involving antidepressants.
In July of 2002, Mr Troy also had a meeting with Michele Corash from the California based Morrison and Foerster law firm. At the time of the meeting, the firm was representing GlaxoSmithKline in a private lawsuit and Michelle Corash was the lead attorney.
In this case, the plaintiff wanted a label on nicotine replacement products with the following: "Warning: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."
In the alternative, the plaintiff sought an injunction requiring the following warning or a similar one: "If pregnant or breast-feeding, ask a health professional before use. Nicotine, whether from smoking or medication, can harm your baby. First try to stop smoking without the patch."
On September 12, 2002, less than 2 months after Mr Troy's meeting with Ms Corash, the FDA filed a brief in support of Glaxo in a case.
Rep Hinchey says this pattern of collusion continued in 2003, pointing out that on December 12, 2003, the FDA filed a statement of interest in the case of, Murphree v Pacesetter, in support of the medical device maker in a Tennessee lawsuit over a faulty pacemaker.
To substantiate this charge, Rep Hinchey described a letter to the FDA that he obtained, dated November 5, 2003, from the law firm representing Pacesetter, Feldman, Gale and Weber, that directed the FDA on how it should assist the company in the lawsuit against the private citizen whose heart device did not work.
Rep Hinchey also told members of Congress that another action by Mr Troy aimed at protecting Big Pharma, "was his publishing in the Federal Register a notice questioning whether FDA's own regulations complied with the first amendment."
This notice was troubling, the Congressman said, because it would be used against FDA in lawsuits. The Congressional Research Service looked for a precedent for any similar prior actions and reported: "We were not able to uncover any similar instance where a Federal agency issued a notice seeking the type of public comment on a constitutional issue and regulatory issue such as this one which was sought out by Mr. Troy."
After receiving 700 filings and spending 600 hours on this matter, Rep Hinchey said, the FDA decided to drop it, once again wasting taxpayer money.
According to the Congressman, his amendment to cut funding to the Chief Counsel's office was about more than just an FDA office wasting money. The FDA's Chief Counsel, he warned, was taking actions to undermine the FDA's ability to carry out its mission.
Mr Troy was shutting down avenues used to expose fraud in the drug industry and making it easier for drug companies to produce misleading advertisements, he said.
Rep Hinchey wanted to add funds to FDA's Division of Drug Marketing, Advertising and Communication. A division, he said, which consisted of only seven people who were responsible for reviewing the accuracy of direct to consumer ads for prescription drugs. In 2003, he said, the 7 people reviewed 38,400 ads, a 6% increase over the year before.
However, he pointed out, despite the increase in ads reviewed, the number of enforcement letters sent to drug makers for false and misleading advertisements dropped 75% in 2003.
"The reason for this drop," Rep Hinchey said, "was not that the drug companies suddenly cleaned up their act."
In fact, all public information indicates the opposite. The real reason, he says, was a conscious effort by the FDA to weaken advertising regulations.
Shortly after he took office, Mr Troy instituted a policy in which all advertising warning letters had to go through the Office of Chief Counsel. Prior to this, all letters were sent to drug companies from the Division of Drug Marketing. So once the letters had to go through the Chief Counsel for approval there was a 75% reduction in letters sent.
Between January 1999 and December 2001, the Division issued more than 270 letters, or an average of about 90 a year, but under Mr Troy's reign, that number dwindled to fewer than 30.
However, during an investigation instigated by the House Committee on Government Reform, the FDA provided no records from the Chief Counsel even though the June 26, 2006, report on the investigation, "Prescription for Harm: The Decline in FDA Enforcement Activity," says a previous investigation had attributed a sudden decline in enforcement actions to a change in FDA policy in September 2001, that required all letters to be approved by the Chief Counsel before being issued.
Under the revised procedures, the report notes, the Chief Counsel is required to "state in writing the reason for nonconcurrence" whenever it objects to an enforcement action.
Yet when the FDA was asked to explain why there were no records from the Chief Counsel's office, FDA staff said that the Chief Counsel does not maintain copies of its decisions on recommendations or even a record of which files it reviews.
"These recordkeeping and case tracking practices are inadequate and resulted in a haphazard and untimely response to the Committee's document requests," the report said.
They also appear to violate the Federal Records Act, the report noted, which require agencies to create and maintain records "sufficient to ... document the formulation and execution of basic policies and decisions and the taking of necessary actions, including all significant decisions and commitments reached orally."
US News sought records for the meetings that Mr Troy had with the pharmaceutical industry under the Freedom of Information Act but said it was informed by his office that there are "no minutes, no memos, no nothing."
When the preemption preamble in the new labeling rules for prescription drugs was made public, Congressman Hinchey was outraged. "This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue," he stated, "as well as the purpose for which the agency was created: to protect the American people."
"Drug companies must be held accountable when their products do serious harm," he said in a statement released on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On its Web site, in listing Mr Troy's accomplishments at the FDA, his new employer brags about the very conduct complained about by members of Congress that led to the $500,000 cut in funding for the Office of Chief Counsel, stating:
"He oversaw the agency's warning and untitled letters, helped raise the agency's focus on First Amendment issues, and played a principal role in the FDA's generally successful assertion of preemption in selected product liability cases."