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Context of 'August 2001: Bush Appoints Daniel E. Troy as the FDA’s chief counsel'

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President Bush appoints Daniel E. Troy as the FDA’s chief counsel. [Financial Times, 8/14/2001] Before taking the position, Troy was a partner at the law firm Wiley Rein & Fielding, where he sued the FDA several times on behalf of drug companies, including pharmaceutical giant Pfizer. He has repeatedly argued that the agency has only limited authority to regulate drug companies. Troy is mostly known for his involvement in the landmark Supreme Court case that ruled the FDA does not have the authority to regulate tobacco. [Boston Globe, 12/22/2002; Denver Post, 5/23/2004] As chief counsel, Troy will help the FDA commissioner, a post that is currently vacant, to draft policy and enforcement provisions. The commissioner’s post will remain vacant until October 2002. So far, Bush has considered two people for the position—Michael Astrue, senior vice-president at Transkaryotic Therapies, a British biotech company, and Eve Slater, Merck’s senior vice-president. In both cases the Senate made it clear that their nominations would be rejected because of their involvement in FDA-regulated industries. [Financial Times, 8/14/2001]

Entity Tags: Daniel E. Troy, George W. Bush

Timeline Tags: US Health Care

The US Department of Health and Human Services implements a new policy requiring that all enforcement letters to drug companies potentially engaged in false advertising be pre-screened by FDA Chief Counsel Daniel E. Troy. Prior to the policy change, the FDA’s drug-marketing division and district offices were free to determine when an enforcement letter was warranted. After the policy change, the number of enforcement letters sent annually drops by two-thirds. [Boston Globe, 10/19/2002; Boston Globe, 12/22/2002; Denver Post, 5/23/2004] In October 2002, the General Accounting Office (GAO) finds that the FDA is taking so long to review the letters that “misleading advertisements may have completed their broadcast life cycle before FDA issued the letters.” [Boston Globe, 12/22/2002] Fifteen months later, another report by the GAO finds that the review process is still slow, with the average approval time being six months. [Boston Globe, 1/30/2004]

Entity Tags: Daniel E. Troy, US Department of Health and Human Services

Timeline Tags: US Health Care

The Boston Globe reports that the FDA is considering the validity of the pharmaceutical industry’s argument that the agency’s regulation of drug advertisements violates manufacturers’ “free speech” rights. The inquiry is being led by FDA Chief Counsel Daniel E. Troy, who represented drug companies before being appointed to the FDA position in August 2001 (see August 2001). [Boston Globe, 10/19/2002]

Entity Tags: Daniel E. Troy

Timeline Tags: US Health Care

Pfizer attorney Malcolm Wheeler calls FDA chief counsel Daniel E. Troy requesting that the agency intervene in a lawsuit filed against the company. The lawsuit alleges that Zoloft, an antidepressant drug manufactured by Pfizer, caused Victor Motus of California to kill himself on November 12, 1998. It also says that the drug company should have warned physicians that Zoloft might cause suicidal thoughts in some people. On September 3, the FDA files a brief stating that the agency’s scientists have found no evidence that antidepressants cause suicidal thoughts. Furthermore, the FDA argues, if Pfizer had warned doctors of such a link, it would have been a violation of the law because all warnings must first be vetted by the FDA. According to Troy, the agency has “absolute control over the label.” This position, notes one of the plaintiff attorneys in the Pfizer case, contradicts arguments that Troy made when he was practicing in the private sector. Before he had argued that the agency’s rulings were arbitrary and capricious. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Pfizer, Malcolm Wheeler

Timeline Tags: US Health Care

FDA chief counsel Daniel E. Troy intervenes in a lawsuit against Glaxo SmithKline, the manufacturer of the drug Paxil. The FDA says it disagrees with the judge’s temporary order that the phrase “not habit-forming” be removed from the company’s advertisements promoting Paxil. The plaintiffs in the case alleged that the phrase is misleading because they experienced withdrawal symptoms after they stopped taking the drug. The judge agreed saying, “It is difficult to imagine that the FDA would object to the removal of the reference that ‘Paxil is not habit-forming.’” But Troy does object. The FDA, taking the side of Glaxo SmithKline, says the product is not habit-forming and contend that the symptoms experienced by patients were not withdrawal symptoms, but rather symptoms of “discontinuation syndrome.” According to Troy, the FDA has absolute authority on the content of drug labels. Following the FDA’s intervention, the judge lifts her temporary order. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Glaxo SmithKline

Timeline Tags: US Health Care

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