Statement by Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, Regarding the State of the Union Address

Published Online: Wednesday, January 29, 2014
PRESS RELEASE

WASHINGTON, DC (January 29, 2013) — “In last night’s State of the Union address, President Obama said, ‘Today in America… [a] rural doctor gave a young child the first prescription to treat asthma that his mother could afford,’ vividly capturing the critical importance of access to safe, affordable medicines for our nation’s patients and our health care system.

Indeed, in the 30 years since the enactment of the enormously successful Hatch-Waxman law in 1984, which struck a balance between competition and innovation in the pharmaceutical marketplace, generic utilization has now grown to be 84% of medicines dispensed. This success has generated savings for the U.S. health system of $217 billion in 2012 and $1.2 trillion over the most recent decade, according to the fifth annual Generic Drug Savings in the U.S. report, compiled by IMS Health on behalf of GPhA.

And it all rests on the foundation of the Food and Drug Administration’s (FDA’s) approval of generic medicines as scientifically equal to the brand medicine in drug safety, efficacy and quality. As the preeminent public health agency in the world today, doctors and consumers can rely on the FDA’s determination of sameness to be confident in generic drugs.

Unfortunately, the FDA’s current Proposed Rule on Labeling would undermine the Hatch-Waxman Act and put both patient safety and health care savings at risk, according to a new GPhA white paper on the topic.

As drafted, the proposed rule would create substantial confusion for pharmacists, doctors, nurses, patients and others in the health care system by allowing for multiple, different drug labels in the market for the very same product, upending 30 years of law and regulation. This would not only jeopardize patient safety, but would also cause billions of dollars in increased costs for consumers, taxpayers, large and small businesses, and state and federal governments. The rule would decrease patient access, impede healthcare decisions and delivery, and make fewer generic drugs available.

The sustainability of our health care system, indeed our national economy, depends on the continued access to safe, effective, more affordable generic medicines in a timely manner as envisioned under Hatch-Waxman. Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions. The generic pharmaceutical industry will continue to work with the FDA and other stakeholders to make sure that any changes to labeling rules and regulations protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines.

At a time when all stakeholders and patients are adjusting to the new realities of the Affordable Care Act, we should seek to limit provider confusion about generic prescribing. Unfortunately, the current FDA proposed rule on generic labeling does just the opposite.”

For detailed analysis on the impact of the FDA proposed rule, read the new GPhA white paper:

GPhA Overview and Assessment: Food and Drug Administration’s Proposed Rule Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
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