WASHINGTON Generic drugmakers are furiously campaigning against a proposed U.S. rule that would require them to change the prescribing information on their products if they receive new safety information, which they say would open them to product liability lawsuits.
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 safety data.
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 labeling.
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.
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 branded counterpart.
"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 congressional staff.
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)