GPhA addresses Congress on economic impact of FDA's proposed rule on prescription labeling

WASHINGTON — The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

“By allowing label changes without prior FDA review and approval, the proposal will expose generic drug manufacturers to new liability that will drive up costs of generic drugs by at least $4 billion annually and, furthermore, may create confusion in the marketplace for patients, pharmacists and physicians," said Alex Brill, CEO Matrix Global Advisors. "The resulting cost increase will be borne by both consumers in the form of higher insurance premiums and the government in the form of higher Medicare and Medicaid costs.”

A recent report by Matrix Global Advisors estimated that U.S. healthcare costs would rise $4 billion annually if the proposed rule is enacted. Medicare and other government programs will incur $1.5 billion in annual new spending, while private insurers and patients will pay $2.5 billion per year.

“This proposal directly undermines the ‘sameness’ of generics and their brand counterparts — a fundamental scientific principle that is the very cornerstone of the success of generic medicines in the last thirty years,” stated Gordon Johnston, former deputy director, FDA Office of Generic Drugs. “The proposed rule paves the way for different versions of safety information for the same products, undermining the important principle of consistency. 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. ”