Some 70 Americans will die today because the Food and Drug Administration
doesn't allow existing medical technology to be used to save their lives.
If the FDA approves a product that eventually causes a problem in the marketplace,
it gets into trouble. But if the product isn't available in the United States
and isn't generally known to exist, the FDA doesn't get into trouble even
if thousands of people die for lack of it.
Thus there was no outcry even though 119,000 people died of hypertension
or heart disease during an eight-year wait for beta blockers to be approved.
Or when more than 2,000 died from heart disease during three years of waiting
for Mevacor. Or when 3,500 died of kidney cancer during the three-year wait
for Interleukin-2.
The procedures for bringing new products to use in the United States are
among the slowest and most expensive in the developed world. In the 1960s
it took six years for the FDA to approve a new drug. Now it takes almost
16 years, even with the recently heralded reduction in the time required
for final review to just over a year and a half.
It's time to help the elderly and the ill by bringing drugs and medical
devices to market more quickly. The Progress & Freedom Foundation has
a proposal to do it. It would separate the development and product review
process from the FDA's role of enforcing mandated safety and effectiveness
standards.
The FDA would license private entities called Drug or Device Certifying
Bodies (DCBs), which drug or device manufacturers would retain to oversee
their product's development. Since manufacturers could choose among DCBs,
they could compete to produce a lower-cost, faster, and higher quality process
for drug and device development and review.
More important, the FDA would have 90 days to approve a positive recommendation
by a DCB. If it did not act, the use of the drug or device would be allowed.
This would be far different from now, when the FDA raises hurdle after hurdle,
requires more and more tests, never saying yes, but rarely daring to just
say no. The current bureaucratic gridlock would be broken, so that more
effective treatments can get to the ill.
There's no reason private entities should not be used to review a drug application.
Private entities already perform all functions involved in this process
except the final approval step. Currently, the FDA requires sponsors of
new drugs to obtain approval to begin clinical trials, and then continues
to oversee the sponsor's clinical program through regular reports and other
mechanisms. After the clinical studies are completed, sponsors apply for
FDA approval. The FDA does no testing, but only reviews the data collected
through clinical trials. The FDA would review the DCB's analysis of the
data, and could veto approval if it found the new drug unsafe or ineffective.
The approval process for medical devices needs to be changed, too. Currently,
if a device is not substantially equivalent to one already on the market,
it must go through a complex clinical trial process even if it's a simple
device that carries little or no risk. The breast examination pad, for example,
is two pieces of plastic with a layer of silicone in between. It has no
moving parts, is non-toxic, and in use does not invade the body. But it
is illegal in the United States because there is no analogous product on
the market. So years of testing loom while women whose lives could be saved
by it are forbidden to use it.
Finally, there is the question of liability. Where the treatment of patients
with serious medical problems is involved, there are going to be adverse
outcomes from the use of drugs and even death on occasion, no matter how
responsible the manufacturer and how strict the regulation. U.S. companies
are not permitted to defend themselves from lawsuits simply by pleading
that they have complied with regulations. As a result, manufacturers of
some pharmaceuticals have simply quit making them. Here, we might look to
Europe, where regulatory standards protect the patient, but a company is
free of tort liability if it can show that the state of scientific and technical
knowledge when the product went into circulation was not such as to enable
the existence of the defect to be discovered.
The FDA was designed for the 1930s and is bureaucratically incapable of
handling the exploding technological advances of medicine in the 1990s.
We must change the current system for bringing medical products to the marketplace
so that our citizens will receive the full benefits of the dramatic scientific
discoveries and medical breakthroughs our nation's vast research establishment
is producing.
And they need those benefits while they are still alive.
The National Center for Policy Analysis is a public policy research institute
founded in 1983 and internationally known for its studies on public policy
issues. The NCPA is headquartered in Dallas, Texas, with an office in Washington,
D.C.