Dear FDA, Hold on to Your Reviewers!

Reviewers at FDA are the staff that looks into applications from drug makers and medical device manufacturers to market new medical devices and pharmaceuticals. They are highly skilled, specialized individuals, and their role in US healthcare is absolutely critical. Medical device, pharmaceutical, and biotech companies rely on these reviewers to determine that new drugs and devices are safe and effective. And they rely on the reviewers to ensure that new drugs and devices are launched as soon as possible, so that they can benefit the patient population.

Recently, we have seen dramatic reductions in staff across almost all government agencies. At FDA, we know that changes have started, but so far, it appears that the FDA Reviewers are still there… It is my hope that the new Director of the Agency will make sure Reviewers are kept in place and potential reductions in staff do not include these critical individuals.

As a small medical device company, we have worked closely together with FDA Reviewers over the past 9 years to achieve our approximately 50 clearances to market reprocessed single-use devices. Let me make a few things clear: FDA Reviewers are not easy to work with. And they don’t work fast. They are not there to make our lives easy. They are there to make absolutely sure that the devices and drugs they are evaluating are safe and effective. They shouldn’t be easy to work with. And they shouldn’t work fast. We appreciate the level of scrutiny we are exposed to, and we appreciate the rigid insistence on tests and studies that sometimes make it harder and more expensive to bring new devices to market. We appreciate this, because FDA protects us from launching products that aren’t good enough – and they protect the patient population from being exposed to sub-par treatment.

We appreciate the level of scrutiny we are exposed to, and we appreciate the rigid insistence on tests and studies...

I am sure headcount at FDA can be cut. But if the attempt to reduce costs compromises our review process by making it slower (fewer staff) or less stringent (shorter process), consequences will be dire. My company reprocesses single-use devices to reduce the cost of care, and if FDA gets rid of Reviewers, it may take us longer to get our clearances – which costs us money and delays savings for the hospitals.

However, there are many drugs and devices that are much more important than the devices we sell. Some new drugs and devices save lives! If staff reductions at FDA, such as a reduction in the number of Reviewers, result in slower clearance processes, consequences for the patient population can be severe or even fatal.

Likewise, if standards are lowered to reduce costs, consequences can be severe or even fatal. We need Reviewers with high standards, uncompromised diligence, and the time to evaluate new drugs and devices thoroughly.