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 safety information.
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 medicine.
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 letter.
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)