Biomedical Engineering Reference
In-Depth Information
impatient. Finally, Dr Kelsey corrected the misperception of
responsibilities that had crept into the situation.
In the consideration of an application for a new drug,
the burden of proof that the drug causes side-effects
does not lie with the FDA. The burden of proof that the
drug is safe - which must include adequate studies of all
manifestations of toxicity which medical or clinical
experience suggest - lies with the applicant.
32
While this corrective action does not focus on the victims of
the unsafe drug, it does focus on the locus of responsibility
for evidence regarding drug safety.
The Tylenol tampering case can be considered an example
of preventive action. What steps can be taken to prevent the
recurrence of a problem? In 1982, Tylenol was the nation's
leading non-prescription painkiller. In late 1982, a number
of persons in the Chicago suburbs died from cyanide
poisoning after swallowing Extra-Strength Tylenol in capsule
form.
33
It was quickly determined that the capsules had been
opened somewhere along the distribution chain, possibly in
the retail outlet, and the cyanide was added. The capsules
were then reassembled and sold by the unsuspecting retailer
to the unsuspecting consumer. Within a month, the
pharmaceutical industry had asked the FDA to develop
regulations for tamper evident packages.
34
The FDA prepared
new regulations requiring tamper evident packaging which
went into effect in early 1983.
35
While the preventive action
seems to have been reasonably effective, there has never been
a criminal conviction in the case.
36
Finally, the current episodes of
Salmonella
contamination
could represent the need for robust maintenance and
diligent implementation of the system of investigation
and remediation. The contamination of peanuts has taken
