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Proposed Changes to Drug and Device Labeling Regulations Worry Patient Safety Groups

Feb 16, 2016

A Food and Drug Administration (FDA) proposal to relax labeling requirements for drugs and medical devices has sparked concern for patient safety among patient advocates. Patient advocates and industry watchdogs fear that relaxing the labeling regulations will make it more difficult to hold manufacturers accountable for injuries and complications caused by their products, the Minneapolis Star Tribune reports. And the groups are critical of the way the proposal was advanced-included in a 10,000-word, single-spaced notice about regulating tobacco products, though the change would apply to all drugs and devices.

If the proposal is adopted, companies would no longer have to "provide adequate labeling" for non-FDA-approved uses of their products that they know about. The change would apply to the detailed package inserts that are included with virtually all drugs and medical devices. Patient advocates believe manufacturers will use the relaxed rule to avoid liability for injuries caused by off-label uses of their products, the Star Tribune reports.

Companies argue that current rules infringe on their free-speech rights. Companies want to be able to promote their drugs for uses that have not yet received FDA approval, but patient advocates say experimental applications can put patients at serious risk, according to the Star Tribune. Medtronic PLC, the world's largest medical device maker, did not comment on the new rule. Medtronic is fighting thousands of off-label promotion charges from patients who claim they were injured by unapproved uses of Medtronic's Infuse bone graft device.

Diana Zuckerman, president of the nonpartisan health policy think tank National Center for Health Research, says the FDA is moving in "a very dangerous direction." Zuckerman urged the FDA to "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?"

According to the American Medical Association, off-label use ranges from 10 to 20 percent of all prescriptions but can be much higher in some medical specialties. A doctor is permitted to prescribe a drug or use a medical device in non-approved ways if the doctor feels the treatment will benefit the patient. Manufacturers, however, are not permitted to market their products or discuss them with doctors except for approved uses.

The device industry wants the FDA to remove from labeling laws "generic references to evidence beyond a manufacturer's promotional claims." This includes a section of the regulation that lets the FDA determine intended uses based on "circumstances surrounding the distribution" of products. In existing FDA law, circumstances include "labeling claims, advertising matter, or oral or written statements." AdvaMed, an industry trade group, encouraged the FDA to make clear that "truthful, nonmisleading scientific exchange is not evidence of a manufacturer's intended use," according to the Star Tribune.

Kim Witczak, who founded the patient advocacy group Woody Matters after her husband's suicide, feels that relaxing the regulations will make it harder for people to hold manufacturers accountable for injuries caused by off-label drug and device uses. Witczak's husband killed himself after being prescribed the antidepressant Zoloft for insomnia.

Consumers groups object to the way the FDA seemed to be hiding a significant labeling change proposal, according to the Star Tribune. Allison Zieve of Public Citizen criticized the FDA for taking a roundabout route. "If the FDA is going to revise an important device regulation, it should be made clear," she said. "The title of this rule-making notice seems to be about tobacco."

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