FDA attempts to shield drug makers from liability

New rules to be adopted by the Food and Drug Administration are set to redefine labelling requirements for pharmaceutical drugs. The new rules will go into effect on June 30. At the last minute, language was inserted into the new rule to attempt to limit liability of drug companies for the harm their faulty products might cause patients -- eliminating a patient's standing to bring lawsuits.

One might argue that the FDA has no legal authority to make such sweeping rules, and that may be the case. At the very least, this should leave no doubt in anyone's mind who the FDA is representing, and it is not the general public. Probably the agency should be renamed the Bureau of Pharmaceutical Industry Shelter and Sales. You can work an appropriate acronym yourself.

Here's what the June 8 issue of the New England Journal of Medicine had to say about the FDA's latest move:

"The most troubling aspect of the FDA's
new plan, however, has nothing to do with
providing information to prescribers. In
an unusual move after the end of a five-year
period of comments on the initial rule, the
agency used the passage of the new labeling
regulations to quietly add a new section to
its preamble that will make it extremely difficult
for anyone to bring legal action against a drug
manufacturer for harm caused by one of its
products. For years, the pharmaceutical industry
had sought to pass legislation that would prohibit
litigation over adverse effects as long as the
medication was approved by the FDA; Congress
has consistently rejected this idea. But after
the comment period for the new labeling regulation
had closed, language was added to the final rule
stating that any FDA-approved label, 'whether
it be in the old or new format, preempts . . .
decisions of a court of law for purposes of product
liability litigation.'

"Beginning at the end of this month, the new
regulations would preempt nearly all action by
patients in state courts against drug manufacturers
for unanticipated injuries resulting from the use of
their products. This immunity would apply even
if a company failed to warn prescribers or patients
adequately about a known risk, unless a patient
could prove that the company intentionally
committed fraud — a very hard test to meet.
Several members of the House and Senate have
vigorously objected to this provision, as well as to
the fact that there was no opportunity to debate it
before the regulations were made final; court
challenges are likely.

"Ironically, this low-profile aspect of the new
rules could have an effect on the health care system
that is much more profound than the small-scale
improvements of the new labeling rules themselves.
'It will make it impossible to file liability claims,' said
a former FDA general counsel who is now in private
practice."

As a conservative, I don't like judges legislating from the bench. I especially do not like career bureaucrats legislating by fiat from inside the executive branch -- that is equally unconstitutional.

Let your voice be heard in Washington. You have only about seven days of freedom left to file a lawsuit for damage a negligent drug company has caused. [LINK]