Last week the Supreme Court ruled that medical device-makers are protected from personal injury lawsuits so long as their products have passed the most stringent FDA approval process. The principle that the Justices cited in their decision was “preemption”—the idea that the FDA stamp of approval is final, binding, and supersedes any problems or malfunctions that may subsequently occur.  This means, more or less, that if your pacemaker blows up the device-maker can shrug and say “sorry buddy, the FDA gave it the okay; you’re on your own.”

As harsh as this may sound, there is an argument to be made for preemption. The principle was pretty clearly written into a 1976 medical device law and the pro-business contingent has a point when it says that without some degree of preemption, competition is nigh impossible (it’s tough to navigate 50 different state codes, and the companies that can are the big, established ones).

But regardless of the principles behind the Court’s decision, the practical dimensions of the ruling leave much to be desired. Preemption only has teeth if the FDA does—but the agency is all gums.

For years, the FDA has been in a state of steady decline. According to a former FDA chief counsel, the agency’s staff has shrunk 14 percent over the last 14 years. Experts say the FDA needs a 15 percent boost in funding per year for the next five years in order to be effective, and a November report revealed that the FDA barely has any computers or personnel infrastructure.

In short, the FDA is a mess, and the entropy hasn’t spared medical device regulation. To help fill its empty coffers, since 2002 the FDA has had a system in place that allows device-makers to pay fees in order to expedite product inspections. It is estimated that between 2007 and 2012, the FDA will collect $287 million in fees from medical device companies—just over a fifth of the total cost to the FDA to review new devices.

The obvious problem here is that the FDA has an incentive to churn
through devices as quickly as possible: faster approvals mean more
manufacturers will pay the fees, thus helping the FDA make up some of
its funding gap. And rushed inspections are usually poor inspections.

The FDA’s medical device fee-system is almost identical to its drug
inspection system and the results there have been less than promising.
In October of last year, an inside source at the FDA told Maggie
that the performance goals (e.g. targeted turn-around times for
approval) associated with a fee-based system have compromised drug
approval standards.

“For the drug-maker it’s a gamble,” said the source. “The company is
betting that, because we want to make the 10-month deadline [for
reviewing and approving new drugs], we won’t send the application [for
approval] back. If you find a problem or there is something missing
[from the application] and it doesn’t seem terribly material, there is
a tendency to overlook it. Because if you don’t it will just delay the
whole process. “Now,” he says, “we send it back [only] if it’s really
crappy.”

There’s no reason to believe that medical device regulation won’t fall
into the same pattern of cutting corners—not just because of the fee
system, but also because of the general impotence of the FDA. In 2005,
The New York Times reported that
the FDA issued an internal memo stating “that the agency had little
idea whether device manufacturers were fulfilling their obligations to
conduct studies on the safety of products once they were on the
market.”

Late last month, the Government Accountability Office (GAO) issued a report
condemning the FDA for failing to meet “the statutory requirement to
inspect certain domestic establishments manufacturing medical devices
every 2 years.” Instead, the FDA inspects U.S. device-making plants
every 3 to 5 years and foreign manufacturers a startling one every 6 to
27 years. How comforting.

Granted, the Supreme Court’s decision doesn’t apply to manufacturing
errors; patients can still sue if a device is manufactured to be
out-of-synch with FDA standards. But the broader pattern is still very
clear: the FDA is swiftly approaching rock bottom. 

What’s also troubling for any astute political observer is how the
sides of the preemption controversy have broken down along political
lines. Obviously device-makers are happy about the Court’s ruling—but
so is the Bush Administration. A U.S. deputy solicitor general told the
Court that the absence of preemption would amount to “serious
undermining of FDA’s approval authority and its balancing of the risks
and benefits.” You know something’s up when the anti-government crowd
is celebrating the monopolistic authority of a federal regulatory
agency.

So why the support? The Bush Administration knows better than anyone
that there is more at stake than issues of authority here. After all,
the FDA is an executive agency—the President has a first-row seat to
its epic decline.

Thus the administration is well aware of the reality that the Supreme
Court’s legalistic approach missed: the FDA has been made the final
word on nationwide safety standards for medical devices as it slumps
toward total paralysis. And if the FDA can’t do it’s job, then
preemption is an empty doctrine—logically sound in the courtroom, but
practically ineffective in the real world.