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Context of 'October 2001: FDA Chief Counsel Orders Pre-Screening of All Enforcement Letters Sent to Drug Companies'

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Thomas A. Scully is sworn in as head of the Health Care Financing Administration (HCFA), a division of the US Department of Health and Human Services. Prior to joining the Bush administration, Scully served as president and chief executive officer of the Federation of American Hospitals, a trade association that lobbies on behalf of 1,700 privately-owned and managed community hospitals and health systems. He held that position for six years [Healthcare Financial Management, 7/2001; US Department of Health and Human Services, 11/10/2003] and was making $675,000 a year when he left. As the administrator of HCFA, he will be paid a salary of $134,000 a year. [New York Times, 12/3/2003] During his confirmation hearings, Scully promised the Senate Finance Committee that he would “aggressively enforc[e] the fraud statutes.” Under the Clinton administration, the Justice Department had brought a number of lawsuits against hospitals alleging that they had over billed Medicare, Medicaid, and other federal heath programs. [Iglehart, 12/27/2001]

Entity Tags: Thomas A. Scully

Timeline Tags: US Health Care

Ann-Marie Lynch, deputy assistant secretary in the office of policy at the Department of Health and Human Services, allegedly blocks the release of several government reports that contradict claims made by the drug industry. One of them is a 2001 report stating that involvement of private health companies in Medicare’s prescription-drug benefit programs would lead to higher prices and would not work well in rural areas. [Denver Post, 5/23/2004]

Entity Tags: Ann-Marie Lynch

Timeline Tags: US Health Care

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 announces that it has released $126 million for disaster related expenses. The figure includes $10.4 million for environmental hazard control to pay for worker safety measures, technical assistance for responding to hazardous environmental exposures, and potential needs related to exposure to contaminants. [US Department of Health and Human Services, 9/21/2001]

Entity Tags: US Department of Health and Human Services

Timeline Tags: Environmental Impact of 9/11

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

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