Why We Need a Pharma Safety Board
Posted by: Reuben Guttman On: July 25th, 2011 | Number of Comments: Comments Off
When there is a train wreck, the National Transportation Safety Board (NTSB) does an investigation and creates a public record so that lessons can be learned from mistakes.
Defective drugs that cause injury or drugs that are misbranded and cause injury are in some ways also “train wrecks”, but unfortunately there is no public vetting of what went wrong. When drug companies make misrepresentations about their products or use unlawful marketing tactics, it always seems as though the company pays a fine and the public — particularly the medical community — never really learns the details of the derelictions. Simply stated, there is no public vetting of what went wrong so that regulators and medical professionals can learn the truth about products they have helped place into the market.
With the cost of drug expenditures soaring — combined with evidence that the pharmaceutical industry has reaped huge profits from drugs that were illegally marketed at public health risk — the time is ripe for Congress to pass legislation creating a Pharmaceutical Safety and Investigation Board. Where the government settles a False Claims Act (FCA) case or a case involving a violation of the Food, Drug and Cosmetics Act (FDCA), the Board would be empowered to analyze the record developed in the course of the FCA or FDCA investigation, conduct its own investigation, and issue a public report. The information developed and disclosed by the Board would be essential to informed medical decision making. It would –in part — be a first step in taking the pharmaceutical industry out of the business of drug education.
With an epidemic of industry misconduct as demonstrated by recent FCA settlements with some of the major pharmaceutical manufacturers, the time is right for Congress to move on a Pharmaceutical Safety and Investigation Board.
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