The FDA has proudly patted itself on the back, again. It announced that its 36-point Plan of Action to streamline and speed up the pre-market approval process for medical devices is a success! How do you streamline and speed up the pre-market approval process for medical devices, at what risk to the consumer, and why would any consumer want to increase any potential risk that this might cause? Well, the consumers did not ask for it, the medical device manufacturers did, and consumers were not asked if they wanted a streamlined process or what that streamlined that process would look like.
The FDA tells us now that streamlined process is a 2 year initiative that was created to deal with complaints by the device manufacturers about the amount of time it was taking the FDA to approve their medical devices so it could start making money from their sales. The manufactures complained about the lengthy application approval review process and resulting backlog of medical device applications. So the FDA sought to and has reduced the average time it takes to clear an application, reduced the backlog of applications and reduced the amount of time it takes to reach a decision on the applications. To the FDA, it was not a matter of making the process more efficient. The FDA shortened the approval process itself. Here is the result:
The percentage of submitted applications that are approved have increased 10% from its low in 2010 when this initiative was begun, a rate that had been declining since 2004. The percentage of filed pre market approval applications that are approved has risen 20% from its 2010 low, which rate had been declining since 2005.
One more very interesting and telling fact: The percentage of applications in which the FDA requested additional information from the manufacturer during the 1st review cycle under this initiative has begun to decrease, following a steady rise from 2002 through 2010.
So, with the device manufacturers’ help the FDA figured out that what was bogging down their approval process was the FDA’s diligence in making sure the medical devices seeking approval were safe. To successfully speed up the approval process, the FDA requested less information from the manufacturers regarding the devices’ safety.
If you ever doubted that the medical device manufacturers’ lobby the FDA, or the extent to which it lobbies the FDA, doubt no more. The device manufacturers’ lobby efforts have emasculated the rigid approval process that while it slowed the process down – protected consumers from unreasonable dangerous medical devices. This increased risk is compounded by the U.S. Supreme Court’s check of state tort law protections that provided recourse to hold a medical device manufacturer responsible for serious injuries or death caused by and unsafe products.
Faster is not better in an application review system’s checks and balances designed to protect innocent consumers. Fast track medical device approvals from the FDA’s asking less questions of the manufacturers about the safety of their products is not good public policy and does not protect consumers. Just as fast dogs that chase cars are sure to get hit, medical devices that race through an abbreviated approval process sure to seriously injury and kill innocent consumers.
Faster is not better. Questions regarding safety have to be asked and answered until the FDA is confident that the medical device is safe, even if it slows the approval process. The FDA is charged with the responsibility of policing the drug and medical device companies and protecting the public health. It has to assure the safety, effectiveness, and security of medical devices.
It cannot put innocent consumers at risk of serious injury or death to appease the device manufacturers and their lobby. The process of taking the time needed to ask important questions and get answers about the risks of medical devices cannot be shortened at the innocent consumer’s expense. Had the FDA asked consumers about the short cuts that were taken that could put them at risk for serious injuries and death, they surely would have told them they did not want the FDA to lower the bar for a medical device to be approved.
Again, the FDA claims it has not lower the bar for a medical device to be approved. It only sped up the approval process by requesting less information from the manufacturers regarding the medical devices’ safety.