INCOMPATIBLE GOALS FOR THE FDA
When it comes to lifesaving drugs, we want both safety and speed. We want safety because a drug that cures one disease should not cause another. We want speed because the longer it takes for a lifesaving drug to hit the market, the more people will die because it was not available in time to save their lives. In the 1980s, there was a public outcry because the FDA took nearly three years to approve most drugs; with the AIDS epidemic in full swing, that meant that many people died before the drugs that would save them became available. With the help of Congress, the FDA and the drug industry eventually worked out an arrangement in which companies would pay millions of dollars in fees in return for an FDA guarantee that drug reviews would be completed within a year or within six months for a medicine that would save lives. The arrangement effectively addressed the problem of the time required for FDA approval; however, a new problem arose. Drug companies would not let their money pay for drug safety monitoring after the drug was on the market. As federal funding slowed, and the FDA became increasingly dependent on industry funds, the safety program diminished and speed became the watchword. The deal required that the FDA submit annual reports on review time but not on the safety of drugs that were already on the market. Managers are judged by the speed with which decisions are made; questions about safety are seen as simply slowing down the decision process. FDA employees who speak out about safety concerns report that they are often ostracized and penalized for expressing their concerns.
1. What are the ethical issues in this case? Who are the stakeholders and what are their stakes?
2. When dealing with drugs that treat critical illnesses, how do you decide between speed and safety when enhancing one diminishes the other? On what basis are you making your decision?
3. Was it wrong for companies to help fund drug testing when it meant that lifesaving drugs could be available to patients more quickly? Were the problems that arose inevitable?
4. If you were responsible for regulating pharmaceutical drugs, what changes would you make to alleviate this situation? What trade-offs would you make? What type of industrial policy would your decision be advocating? Be specific.