| WASHINGTON, June 25
WASHINGTON, June 25 Two senior Republican
lawmakers voiced support on Wednesday for the generic drug
industry's fight against a proposed U.S. rule requiring
companies to change labels on products if they receive new
Representative Bob Goodlatte, chairman of the House
Judiciary Committee, and Senator Lamar Alexander, ranking member
on the Senate's Committee on Health, Education, Labor &
Pensions, wrote to the White House's Office of Management and
Budget requesting justification for the cost-benefit analysis on
the proposed rule by the Food and Drug Administration.
If finalized, the FDA's proposal would overturn regulations
that have been in place for three decades that prohibit generic
drugmakers from updating safety data on labels without the
changes first being made by the company that developed the
The FDA has said the change is designed to create parity
between branded and generic drugmakers and make it easier for
generic drug companies to pass on safety information.
Generic drug companies say the proposed rule would open them
to product liability lawsuits and raise the cost of products.
Goodlatte and Alexander said in their letter that the FDA
did not consider litigation-associated costs in its cost-benefit
analysis. It cited figures from a report commissioned by the
Generic Pharmaceutical Association suggesting the costs of the
proposal rise to $4 billion a year when litigation is included.
The FDA assessed the cost of making label changes at between
$4,237 and $25,852.
FDA officials were not immediately available to comment on
The stakes are high for generic drugmakers, whose
association has been agitating against the proposal since it was
announced last November.
In 2011, 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. The result has
been that consumers taking a brand name drug have legal recourse
if they are injured, while those taking a generic do not.
The FDA's proposal would remove the protection against
lawsuits and require both brand name and generic drugmakers to
take responsibility for monitoring drug safety.
Consumer watchdog Public Citizen filed a petition in 2011
asking the FDA to authorize generic drugmakers to revise their
own product labels. The organization said that was important
because there are roughly 2,000 generic drugs on the market -
about 45 percent of all those sold - for which there is no
longer a branded counterpart.
Both generic and brand name drugmakers must report adverse
events to the FDA. The agency typically relies on the companies
themselves to monitor for safety.
(Reporting by Toni Clarke in Washington)