FDA fee for 90% of device applications is less than $5K

The FDA requires adequate industry financial support for essential regulatory protections.

The Patient, Consumer, and Public Health Coalition Priorities:
Medical Device User Fee Act (MDUFA III) Reauthorization

Every five years, the FDA’s user fees for prescription drugs and
medical devices must be reauthorized, and that legislation has to pass
because the FDA could not survive without it.  Negotiations between
the medical device industry and FDA on the medical device user fees
have been contentious this year.  If device companies keep refusing to
significantly increase user fees over the next 5 years, patients will
be harmed.
User fees improve staffing and resources needed to ensure the safety
and effectiveness of millions of devices that we all rely on, such as
contact lenses, mammograms, artificial knees, and tests for HIV and
cancer.  However, the user fees should be used to improve the ability
of the FDA to ensure safety and effectiveness, not just to speed up
the review process.  When the FDA lacks resources to do its job well,
it means more recalls, which are bad for patients and companies.  For
example, recent recalls of dangerous hips will cost billions of
dollars for replacement surgery paid by Medicare, Medicaid, VA, and by
individual taxpayers.  Recalls also mean red ink for companies and job
losses for employees.
We support legislative and regulatory efforts to bring safe and
effective devices to market as quickly as possible. However, ensuring
proof of safety and effectiveness is the most important mission of the
FDA.  Careful review and clear, consistent FDA policies ensure that
new medical products will be beneficial to patients and consumers as
well as the companies’ financial health.
More than 90% of medical devices are not required to be proven safe or
effective in clinical trials, and instead are reviewed through the
510(k) process, which is much less rigorous than the approval process
for medications.  The recent Institute of Medicine report on medical
devices stated that the 510(k) process should be replaced because it
does not determine that a device is either safe or effective.  It
notes that 510(k) approval decisions are based on their substantial
equivalence to devices already on the market—which were also not
necessarily proven safe and effective.  The report also concluded that
the process “does not reward innovation” and it can’t be determined if
the process “has had a positive or negative effect on innovation.”
Given the FDA’s lack of resources and pressures from industry to
quickly approve devices, the Agency will not revamp the 510(k) process
in the near future.  We therefore recommend incremental changes based
on the IOM recommendations and other reports.
For MDUFA reauthorization, we support reforms that:
• Strengthen the standards for approval, such as requiring clinical
trials for implanted devices
• Create a unique ID system for medical devices, similar to the one
for cars and toasters
• Improve the adverse event reporting database for devices (called
MAUDE)
• Review direct-to-consumer (DTC) advertising before it can be used,
to ensure accuracy
• Revamp the de Novo process, but not as a substitute for a PMA for
higher-risk devices.
We oppose efforts to weaken the conflict-of-interest rules for
advisory committee members.
User fees for medical devices are dramatically lower than user fees
for drugs.  The FY2012 user fees for more than 90% of device
applications, including artificial hips and knees and many cardiac
devices, is $4,049 per application (less than half of 1% of the cost
of a drug application). The largest companies currently pay user fees
of $220,050 for the most complicated life-saving device applications,
which is 12% of the same company’s user fees for prescription drug
applications ($1,841,500), and about 20% of what the device review
actually costs the FDA.  Smaller companies pay much less in user
fees.  As a result, FDA lacks the resources it needs to review device
applications in a timely and comprehensive manner, and to require the
clinical trials that are needed to assure the safety of all implanted
devices. Congress must ensure that the FDA has the appropriations it
needs, and device user fees must make a more equitable contribution.