Last month, when I wrote about the Obama administration's
apparent flip-flop on the question of federal pre-emption of
product liability claims against generic drugmakers, I mentioned
a curious footnote in the Justice Department's Supreme Court amicus brief in Mutual Pharmaceutical v. Barrett. All the
wrangling over liability for generics, which are required by law
to use the same labels as the brand-name drugs they replicate,
could be unnecessary, Justice hinted. "This office has been
informed that Food and Drug Administration is considering a
regulatory change that would allow generic manufacturers, like
brand-name manufacturers, to change their labeling in
appropriate circumstances," the brief said. "If such a
regulatory change is adopted, it could eliminate pre-emption of
failure-to-warn claims against generic-drug manufacturers."
I should have given the footnote more attention. In the last
couple of weeks, it has prompted speculation by a number of pharma websites about whether the FDA really intends to upend
longstanding policy barring generics from altering their labels,
and, if so, what that portends for their product liability
exposure. On Wednesday, I emailed the FDA to ask. In an email
response, an FDA representative confirmed what the Justice
Department footnote suggested: "FDA is considering a regulatory
change that would allow generic manufacturers, like brand-name
manufacturers, to change their labeling in appropriate
circumstances," the agency said. "FDA intends to provide an
opportunity for public comment with respect to any such proposed
changes to its regulations."
The FDA email, according to Kurt Karst of Hyman, Phelps &
McNamara (and the FDA Law Blog), is the first confirmation of
what FDA watchers have been anticipating since the U.S. Supreme
Court's 2011 ruling in Pliva v. Mensing freed generics from
liability for failing to warn consumers about dangerous side
effects.
So, will generics welcome the opportunity to provide
consumers with more information about potentially dangerous side
effects of their drugs? Not bloody likely.
As Karst points out, the FDA still isn't giving much away
about its intentions, so it's premature to speculate on how a
policy change would impact liability for generics. Still, the
Justice Department was pretty clear that if FDA policy imposes
labeling responsibility on generics, generic drugmakers won't be
able to rely on pre-emption as a defense. And the last time
generics faced that prospect, when Congress was considering
legislation introduced last year in response to the Supreme
Court's Pliva ruling, the trade association for generic
pharmaceutical companies was squarely opposed to any increased
responsibility for drugmakers.
If Congress enacted a law tasking generics with the
responsibility of strengthening warning labels, the Generic
Pharmaceutical Association argued, "the legislation could create
a situation in which one drug could have multiple different
warning labels. Massive consumer and provider confusion would
result." (I reached out to the trade group for a reaction to the
FDA's confirmation that it's considering a policy change. Claire
Sheahan, a representative, said the group didn't yet have a
response.)
In fairness to the generics, there are reasons why revisions
to drug-labeling policy could end up doing more harm than good
to consumers. Robert Pollock, a former FDA official who is now a
senior advisor at the pharmaceutical consultant Lachman, said
that the Hatch-Waxman Act's mandate that generics carry the
exact same FDA-approved labels as their brand-name counterparts
is an acknowledgement that generics don't engage in safety
testing of their products. Generics manufacturers rely on the
testing conducted by brand-name makers, who are rewarded under
Hatch-Waxman with an extended monopoly on the drugs they
develop. A policy change, Lachman said, could upset the delicate
balance Congress created.
And because multiple generic drugmakers often produce the
same product, Pollock said, the FDA could face different
labeling requests from different companies for the exact same
drug. That could create regulatory bottlenecks and marketplace
confusion, Pollock said - precisely the impediments to low-cost
pharmaceuticals that Hatch-Waxman was supposed to eliminate.
Like regulatory lawyer Karst of Hyman Phelps, Pollock told
me he's eager to see exactly what the FDA is proposing. "This
has caught everyone by surprise," he said. "This is going to be
interesting."
Follow us on Twitter: @AlisonFrankel, @ReutersLegal | Like us on Facebook