WASHINGTON – A move to relax labeling requirements for drugs and medical devices has some patient advocates concerned that people will have a tougher time holding manufacturers accountable for injuries caused by their products.
Under revised language proposed by the U.S. Food and Drug Administration (FDA), companies no longer have to “provide adequate labeling” for non-FDA-approved uses of their products that they know about. The alteration applies to the detailed explanations that come inserted within virtually all drug or device containers.
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Diana Zuckerman, president of the National Center for Health Research, a nonpartisan health policy think tank, questioned the FDA’s reasoning.
“This is part of a direction that FDA has been moving in, and it’s a very dangerous direction,” Zuckerman said. “We know that there are a lot of things that the FDA does not enforce. We don’t think the answer is getting rid of the laws they are not enforcing.”
The FDA, Zuckerman added, is in many ways “an honor system that works for honorable companies. So let’s keep those safeguards that we have, even though they’re imperfect, rather than getting rid of them entirely. How is that consistent with the mission of the FDA to protect public health?”
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Zuckerman was more direct.
“Nobody noticed this because it was hidden,” she said. “And it was hidden for a reason.”
The comment period on the new rule is over for the public, Zuckerman noted. “But it is not over for members of Congress. We think that when we bring this to the attention of members of Congress, they will express their views to the FDA very clearly.”
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