United States Senator Grassley suggests that the U.S. Food and Drug Administration (FDA) should disaggregate the function of monitoring post-approval drug safety from the process approving drugs. With an independent drug safety office, the people who approved the drug in the first place would not be tempted to overlook safety problems that might reflect poorly on the process.
While it's tempting to accept this disaggregation, not everyone agrees. The New York Times notes that even though the FDA needs reform (and what government agency in the world does not?), the disaggregation of safety considerations from the approval process would be a bad idea.
This proposed change to the FDA management structure poses an fascinating problem. On the one hand, disaggregation of authority — of approval process from safety monitoring — would likely engender trust in the FDA. On the other hand, here's an interesting lesson from high-school science classes: certain things can't be disaggregated. "For every action, there is an equal and opposite reaction," otherwise known as Newton's Third Law, and that's a connection that simply can't be broken. As much as we'd like to, scientists and engineers can't disaggregate their way out of basic tradeoffs imposed by nature.
In a similar way, drug approvals must trade off efficacy versus safety; every known drug has side effects, and the approval process balances the harm of side effects with the benefits of medications. If the office that determines efficacy disaggregates from the office that monitors safety, it may become extremely difficult to approve any drug or keep it on the market.
Topics: · ethics · government · health+care · trust
