Page 19
"slip through the cracks." The FDA approved the Bjork-Shir-
ley Heart Valve in 1979. The manufacturer, a Pfizer subsid-
iary, stopped selling the heart valve in 1986 because too
many failed. Though the valve failed in only 0.5 percent of
all patients between 1979 and 1994, 300 people died world-
wide, including 130 in the United States. Despite the low
failure rate, the performance of the heart valve qualifies
as a Type I error because the FDA expected a failure rate
lower than 0.5 percent.
In 1994, Pfizer and the U.S. Department of Justice
agreed to a $10.75 million settlement plus reimbursement of
U.S. government expenses associated with valve replace-
ment.39 The lesson learned from the Bjork-Shirley case is
that Type I errors will on rare occasions still occur,
despite massive government intervention into the marketplace
to prevent them.
Reform Is Not the Solution
Responding to the delays and inefficiencies in FDA
review, Congress has considered a number of FDA reforms.
None has been enacted in the device area. If any had been
enacted, they would have changed FDA's marching orders but
left its monopoly over market access intact. In addition,
the FDA is experimenting with "reform" of medical device
review. That experiment is no more than an outsourcing of
FDA's work to be paid for by device manufacturers. It, too,
leaves FDA's monopoly intact. In any case, it is not ex-
pected to accomplish much.
Tightening the Screws
With the exception of 1992's Prescription Drug User Fee
Act, which allows manufacturers of certain drugs to pay
extra cash to hasten the review process, little FDA reform
has been accomplished. That "reform" takes on an odd form,
to be sure. The taxpayer-supported FDA failed so miserably
at meeting its drug review mandate that Congress now allows
drug manufacturers to give money to the FDA so that the
agency can employ more staff for drug review. Whatever the
merits of the Drug User Fee Act, there is no corresponding
user-fee program for medical devices.
Instead there has been a documented tightening of the
screws at the FDA.40 Consciously stepped-up enforcement
activity, coupled with the FDA's own uncertainty in trying
to please inconsistent congressional taskmasters,41 has pro-