Concern over Proposed Changes to Drug and Device Labeling Requirements

Patient advocates are expressing concern about a Food and Drug Administration (FDA) proposal to relax labeling requirements for drugs and medical devices.

Advocates worry that the change will make it more difficult for people to hold manufacturers accountable for injuries caused by their products, the Minneapolis Star Tribune reports.

Under the FDA proposal, companies no longer have to “provide adequate labeling” for non-FDA-approved uses of their products that they know about. The change applies to the detailed package inserts that come with virtually all drugs and medical devices. The proposal is included in a 10,000-word, single-spaced notice about regulating tobacco products, but it applies to all drugs and devices, according to the Star Tribune. Patient advocates fear that drug and device makers will use the new rule to avoid liability for injuries caused by off-label uses of their products.

This controversy is part of the debate about what companies see as their free-speech rights. The companies want to be able to promote uses that have not yet received FDA approval but such experimental applications can put patients at potential risk, patient advocates say.

Diana Zuckerman, president of the National Center for Health Research, a nonpartisan health policy think tank, said, “This is part of a direction that FDA has been moving in, and it’s 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?”

The American Medical Association (AMA) says that off-label use ranges from 10 to 20 percent but can be much higher in some specialties. Doctors are legally allowed to use drugs and devices in non-FDA-approved ways if they feel the use will benefit patients, but manufacturers are not permitted to market their products for unapproved uses.

Industry advocates argue that less regulation is needed for the development of cutting-edge treatments, while consumers say that the FDA attempted to protect corporations rather than public health, according to the Star Tribune.

Medtronic PLC, the world’s largest medical device maker, declined to comment on the new rule. Medtronic is fighting off-label promotion charges by thousands of patients who claim they were injured by unapproved uses of Medtronic’s Infuse bone graft device.

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. Examples of those circumstances given in existing FDA law include “labeling claims, advertising matter, or oral or written statements.” Industry trade AdvaMed further 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, founder of the patient advocacy group Woody Matters, feels that relaxing the regulations will make it harder for people injured by off-label drug and device use to hold manufacturers accountable. Witczak’s husband killed himself after being prescribed the antidepressant Zoloft for insomnia, not an approved use.

Allison Zieve of Public Citizen says the FDA chose to try to implement the new rule in a roundabout way. “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.”