"Risk management is the leading reason the Food and Drug Administration cites
medical device makers for failing to meet quality requirements, which
makes it all the more striking that when companies look to the agency
for guidance on how to do it, the answer is not very helpful.
Keisha Thomas, associate director
for compliance at the FDA’s Center for Devices and Radiological Health,
told attendees at a recent industry conference that risk management
should be “fluid, living, breathing, moving, evolving constantly” and
“in a state of continuous improvement all the time.”
Talk about a non-answer.
Private companies—whether making
medical goods or anything else—flourish or fail by assessing risk well.
The FDA doesn’t face that discipline. The agency’s only real power is to
remove products from the market or stop them from entering it. That is a
blunt instrument applied to an incredibly dynamic market for medical
goods.
More importantly, accepting risk
is a matter of personal preference and available
alternatives—circumstances that differ for every patient and cannot be aggregated into a one-size-fits-all standard without discarding what makes medical treatment effective in the first place.
The incentive structures are
simply different, leading to different outcomes. Public regulatory
bodies tend toward over-stringency—making compliance costly and
difficult while also pushing patients toward less-safe alternatives.
Private entities may set imperfect standards, but they better preserve
the patient-physician relationships that make treatment work. When
directly compared, private efforts often outperform their public counterparts.
The case of Accutane illustrates
this well. Before the FDA intervened, Hoffman-LaRoche privately managed
the drug’s serious risks—including its potential to cause birth defects—through
a voluntary physician registration system and patient consent
protocols. From 1989 to 1998, pregnancy rates among female Accutane
users nearly halved under this private program. The FDA considered it a failure anyway and replaced it with its own program, SMART, in 2002.
SMART was so burdensome that many
physicians stopped prescribing Accutane. Prescriptions fell 23 percent
in a single year, while pregnancy rates went up. The FDA then replaced
SMART with an even more stringent program, iPLEDGE, which produced
similar results: more paperwork, more patient lock-outs, and no
meaningful reduction in pregnancies. Patients responded by purchasing
Accutane online without prescriptions—precisely the outcome the FDA’s intervention was meant to prevent.
Accutane is a drug, but the FDA’s record on medical devices is, if anything, worse. The agency approved
a Swedish fertility app called Natural Cycles as the first FDA-cleared
contraceptive app in 2018, years after the market had already produced
dozens of similar apps, roughly three-quarters of which accurately
predicted fertile days without any FDA involvement. Natural Cycles
itself was under investigation in Europe for unintended pregnancies
shortly after receiving its FDA blessing. It is not clear that the
agency’s approval added anything the market hadn’t already sorted
out—and the evidence suggests it may not have raised the bar at all.
Then there is the Owlet Smart
Sock. After five years on the market, monitoring the pulse and oxygen
levels of over 600,000 infants with 90 percent accuracy, the FDA sent
Owlet a warning letter in 2021, declaring the product a medical device requiring agency approval. The sock was pulled. No FDA-approved alternative that monitored both pulse and oxygen existed.
As I noted at the time,
the cost was the hundreds of thousands of infants who went without a
reliable monitoring device. By 2022, with RSV sweeping the country, the
cost of over-caution fell on the parents and infants the FDA aimed to
protect.
There is a clear reason the FDA
struggles to provide effective risk-management guidance and seems to
flounder when asked to manage risk for others: it can’t.
Risk is best addressed
by markets, not regulations or federal guidelines. The FDA’s incentives
run toward removing products and avoiding blame, not toward preserving
patient access and physician judgment. Ironically, it’s a real risk to
our health and the healthcare sector to imagine otherwise."