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Context of 'July 2002 and after: FDA Blocking Consumer Lawsuits against Drug Companies'

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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

An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
bullet The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
bullet The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
bullet The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
bullet The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
bullet The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
bullet Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. [Institute of Medicine, 9/22/2006; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Entity Tags: US Food and Drug Administration, Institute of Medicine

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

The FDA begins blocking consumer lawsuits against drug manufacturers and asking attorneys working for drug companies to notify the agency of such lawsuits so it can intervene on their behalf. The agency’s chief counsel, Daniel E. Troy, asserts that consumers cannot sue drug companies over drugs that the agency has approved because FDA decisions on the safety of drugs are absolute and cannot be challenged by any state court. According to the FDA, allowing such lawsuits to proceed would “undermine public health” and disrupt the FDA’s regulation of drugs by encouraging “lay judges and juries to second-guess” FDA experts. Furthermore, the Bush administration argues, lawsuits “can harm the public health” because they may cause companies to remove products from the market or to overstate the risks, possibly resulting in the “underutilization of beneficial treatments.” The policy of prohibiting consumers from suing drug companies, according to the FDA, is meant to protect consumers. This policy differs sharply with the agency’s past practice, which allowed states to adopt stricter standards. But the FDA’s new claim that it has absolute jurisdiction over the question of drug safety preempts state involvement in the regulation over drugs. [New York Times, 7/25/2004] The Boston Globe notes that this policy allows the White House to “use its administrative and legal powers to change the regulatory terrain without taking the often arduous course of asking Congress to change the law.” [Boston Globe, 12/22/2002; New York Times, 7/25/2004]

Timeline Tags: US Health Care

The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. [Center for Reproductive Rights, 11/14/2005; Savage, 2007, pp. 301-302]

Entity Tags: Mark McClellan, Center for Reproductive Rights, Nancy Northrup, Food and Drug Administration, Scott McClellan

Timeline Tags: US Health Care, Civil Liberties

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