Monday, December 06, 2004

Vioxx scandal shows how FDA became toothless

The fact that the FDA is literally powerless in controlling the pharmaceutical industry has caused a lot of concern in the minds of Americans who are essentially at the mercy of for-profit drug companies, which as the Vioxx recall example shows, put profit ahead of human life. But it is obvious that we can't have it all. On one hand we can not ask for small government, and on the other hand, we can't expect the government to be there to protect us.

As is no secret, many of the federal agencies continue to face budget cuts and have either cut back on what they do and how they do it or rely on private sector to help out. Most Americans love it when welfare programs are cut or health care for poor children is eliminated or benefits for immigrants are cut but the Vioxx recall has really hit Americans in the face. Now Americans are seeing what happens when federal agencies become toothless due to shortage of funds.

The Seattle Post Intelligencer and The New York Times have found that:

  • In the 2003 fiscal year, FDA received $200 million from the drug industry - but only if the agency spent a specified level of money on new drug approvals.
  • In the past 11 years, spending on the reviews has increased to more than four-fifths of the budget of the agency's drug center from about half.
  • Among the priorities that took the worst hit was ensuring the safety of the drugs that patients are already taking. It is clear that right now mechanisms for uncovering the dangers of drugs after they have been approved are woefully inadequate, particularly, as was the case of Vioxx
  • FDA now relies almost entirely on the willingness of drug makers to report problems that crop up after a drug has been approved
  • FDA cannot require drug makers to undertake safety tests once a drug is approved.
  • The industry's influence even extends to perks given to agency employees. Under the 1992 agreement, last renewed in 2002, new drug reviewers have healthy travel and training budgets that allow them to attend far-flung conferences and courses. Those who work in the agency's office of drug safety get two-thirds less.

Recommended article: Reforms needed at FDA after Vioxx recall