Blog Post
Study Highlights the Importance of Consumers Right to Bring Suit Against Big Pharma
Posted by: Emily C. Wecht
March 28, 2008
Topic: Defective Products
A study published in the New England Journal of Medicine on Thursday, March 27, 2008 shows that drugs approved by the FDA under tight deadlines are more likely to harm consumers.
The Associated Press reports: "Approval deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision - either approve or reject - on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority. Congress tightened the deadline for most drugs to 10 months in 1997."
The FDA has approved a host of infamous drugs at or near the approval deadlines, including: Vioxx, Bextra, Rezulin, and Baycol. All were withdraw from the market because they were unsafe only after they harmed hundreds of consumers.
The study's findings highlight the importance of a consumer's right to bring suit against pharmaceutical companies that produce dangerous drugs - regardless of whether the FDA has approved the drugs.
For many years, we have fought hard to preserve that right. As Spencer Pahlke reported yesterday, that right is now under attack. The U.S. Supreme Court should consider the realities that this study exposes when deciding Wyeth v. Levine: a federal agency under enormous political and economic pressure cannot unfailingly protect the public. The public must retain the right to pursue justice through the courts.
