by Harold Kim
Executive Vice President, U.S. Chamber Institute for Legal Reform
Last September, ILR President Lisa A. Rickard penned this op-ed which warned that the FDA’s new generic labeling proposal would lead to a “mega” explosion of lawsuits.
This proposal would, as she pointed out, be in direct conflict with the 1984 Hatch-Waxman Act, which has ensured generic drugs’ safety and affordability by requiring generic manufacturers to duplicate the effectiveness and labels of FDA-approved brand name drugs.
It is this law which has allowed the growth in production and use of generic medicines during the past three decades — all of which would be threatened by the FDA’s proposed requirements.
“Market confusion,” Rickard writes, would become the norm, leading to costly lawsuits — and higher health care costs.
Earlier this week, the Washington Legal Foundation, in cooperation with the Generic Pharmaceutical Association and the American Enterprise Institute, held a media briefing to discuss these very consequences of the proposed labeling requirement.
We invite you to watch video of this full briefing here: