Can FDA learn lesson from plane crashes?
When the Boeing 737
Max 8 airplane crashed in Ethiopia, the Federal Aviation Administration was criticized for moving slowly to ground these airplanes. Many other countries pulled this aircraft out of service while the FAA was insisting that the plane was safe to fly.
A few days later, the federal agency reversed course and announced it would ground all the Max 8 airplanes after all. Why was the FAA slower than other countries? Are there lessons from this debacle that might apply to the Food and Drug Administration and pharmaceuticals?
The airline industry has one huge advantage over the pharmaceutical industry: There are two federal agencies that oversee air traffic. One is the FAA, which approves aircraft.
The other is the National Transportation Safety
Board, or NTSB. This is the agency that springs into action when something has gone terribly wrong, such as an airplane crash. Consequently, the approvers are not put in the awkward position of having to determine that they might have made a mistake.
China was the first country to ground the Boeing Max 8 airplanes, within less than a day of the crash. Other countries rapidly followed suit. It was more than two days later when the FAA took action.
Even though the FAA took a few extra days, it still moved a lot faster than the FDA often does. Sometimes it can take months or even years for the FDA to act after it learns about a serious drug problem. There is no independent investigative agency equivalent to the NTSB that can look into drug safety.
The result of this bureaucratic boondoggle is that the same organization that approves medications is also responsible for investigating problems. If it discovers a serious adverse reaction after a medicine has been on the market for a while, the FDA might not move as fast as a neutral organization.
Take troglitazone (Rezulin), for example. It was approved in 1997 over the objections of the FDA medical reviewer. He worried that this diabetes medicine would harm the liver and the heart. British regulators removed it from their market in December of that year.
In the U.S., however, the FDA did not take action to withdraw Rezulin until 2000. That was despite one of its own safety officers sounding the alarm about liver failure.
Another example of the FDA’s slow reaction time is the decongestant phenylpropanolamine. This drug had been included in cold remedies and diet pills for half a century. The FDA finally requested its removal in 2000 because it estimated that PPA was responsible for hundreds of strokes each year.
Perhaps it is time to separate the drug approval process from the process of investigating drug safety failures. A separate and completely independent organization, like the NTSB, might help protect the public from drug disasters.