The rule would overturn regulations that have been
in place for three decades that prohibit generic drugmakers from
updating safety data on their labels without such changes first
being made by the company that developed the drug.
The Food and Drug Administration, which issued its proposal in
November, said the change is designed to "create parity" between
branded and generic drug makers with respect to labeling changes,
and remove an unnecessary impediment to the prompt communication of
Generic drugmakers say the proposed rule would raise the cost of
drugs and lead to confusion among consumers.
"Disregarding decades of regulatory stability in this way will
create unwarranted confusion, raises patient safety concerns and
threatens the system that created thousands of affordable options
for consumers," said Gordon Johnston, a former deputy director of
the FDA's generic drugs division and current an industry consultant
in a statement.
Just as importantly, if not more so from a company point of view,
the move would make generic drugmakers more vulnerable than they are
now to product liability lawsuits.
"The Generic Pharmaceutical Association cannot support a proposed
rule that undermines public health merely to facilitate litigation
against generic drug companies by the plaintiffs' bar," the
association said in a position paper last month.
The House of Representatives Energy and Commerce Committee's health
panel will consider the proposed changes to generic drug labeling
during a hearing on Monday.
MONITORING DRUG SAFETY
Congress adopted the Hatch-Waxman Act in 1984 to speed generic drug
approvals, and over the past 30 years the industry has mushroomed.
Today generic drugs account for some 80 percent of all prescriptions
filled in the United States.
Since generics are designed to be more or less the same as brand
name drugs, from the active ingredients to the way they dissolve in
the body to the prescribing information, the FDA historically
forbade generic drug makers from making independent changes to their
In 2011, after years of legal wrangling,
the Supreme Court ruled that the FDA's prohibition on label changes
meant generic drugmakers should not be held accountable for a
failure to warn against risk. As a result, consumers taking a brand
name drug can have legal recourse if they are injured by a drug, but
those taking a generic effectively do not.
The FDA's proposal would remove that protection and place equal
responsibility for monitoring drug safety on the brand company and
the generic manufacturers.
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Supporters of the proposal say this is particularly important
because there are some 2,000 generic drugs on the market, or about
45 percent of all generics sold, for which there is no longer a
"If generic manufacturers are not actively monitoring and proposing
safety updates, no manufacturer is doing so at all," Allison Zieve,
general counsel at consumer watchdog Public Citizen, said in
testimony to be delivered to the House panel on Monday. "As generic
market share increases, the brand-name manufacturer loses incentive
to devote resources to post-approval safety monitoring."
Public Citizen filed a petition in 2011 asking the FDA to authorize
generic drug makers to revise product labeling through the
procedures available to brand name manufacturers.
Both generic and branded drug companies are required to file reports
about adverse events to the FDA, meaning the agency in theory could
analyze the data, look for trends and make label recommendations
itself. It has historically ceded part of the task to branded drug
companies, due in part to limited resources.
"Given that the FDA cannot monitor all post-approval data by itself,
drug safety is threatened when the regulatory and common-law
incentives designed to motivate manufacturer diligence weaken with
shifting control of market share," Zieve said.
In a twist, the branded drug industry now wants the FDA to take over
that responsibility for any drug for which there are generic
equivalents. That would in theory protect the branded company from
lawsuits by placing the burden of responsibility on the FDA.
"Requiring FDA approval for all safety-related labeling changes for
a multisource drug will ensure uniform labeling across all versions
of a drug," the Pharmaceutical Research and Manufacturers of America
(PhRMA) said in a briefing note circulated earlier this week to
PhRMA has not suggested the FDA take over responsibility for
monitoring the safety of its big-selling branded products.
(Reporting by Toni Clarke; Editing by
Ros Krasny and Lisa Shumaker)
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