Critics see accountability risk if FDA rule changes take hold

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.

The FDA tucked its proposal into a 10,000-word, single-spaced notice about regulating tobacco products, but it applies to all drugs and devices.

While this may seem like nothing more than a change in fine print, patient advocates worry that companies will use the new rule to avoid liability for injuries caused by their products' off-label applications.

The controversy has become another talking point in a growing and increasingly contentious national debate about free-speech rights of companies and off-label uses of their products. Those experimental applications can enrich businesses and drive innovation, but they also put patients at potential risk.

The government is not currently applying the part of the "intended use" regulation that it wants to delete from the law, an FDA spokeswoman told the Star Tribune. Even if it goes away, she added, the agency will continue to have adequate ways to properly monitor companies for misbranding drugs and devices or improperly promoting their off-label use.

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?"

Rates of off-label use vary from product to product. The American Medical Association (AMA) says that overall, 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 they will benefit patients.

The AMA strongly supports that right. It has not taken a position on the proposed labeling changes.

Still, deleting the sentence has stirred strong feelings in other quarters. They range from industry suggestions that less regulation is needed to develop cutting-edge treatment to consumer charges that a putative government watchdog attempted to hide off-label promotion and protect corporations rather than public health.

Medtronic PLC, the world's largest medical device maker and one of Minnesota's top employers, declined to comment on the new rule. The company is battling off-label promotion charges by thousands of patients who say they were injured by non-FDA-approved uses of Medtronic's Infuse bone graft. A company spokesman referred the Star Tribune to AdvaMed, the nation's largest device industry trade group.

In addition to Medtronic, AdvaMed's members include St. Jude Medical, Boston Scientific and other companies in Minnesota's burgeoning medical technology sector. A spokesman for AdvaMed said it did not lobby for the FDA rule change. But the trade group strongly endorsed the revised labeling requirements in formal comments made after the agency proposed to delete the sentence. And it added a request that the FDA cut even more language from "intended use" labeling laws.

As proposed, the new labeling rule is good because the sentence it deletes was not fair, AdvaMed said. If the proposal is made permanent, device and drug companies will no longer be "held to actual or constructive knowledge" of off-label uses.

"An actual use standard is inconsistent with the voluminous legal precedents that make clear intent must be based on the claims made by a manufacturer," the trade group said.

Besides the newly deleted sentence, the device industry also 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."

AdvaMed further encouraged the FDA to make clear that "truthful, nonmisleading scientific exchange is not evidence of a manufacturer's intended use" in order "to align the regulations with First Amendment jurisprudence."

Patient advocate Kim Witczak of Minneapolis believes reduced regulation 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 Zoloft, an antidepressant, for insomnia. Lack of knowledge about potentially dangerous side effects from off-label uses led Witczak to form a patient advocacy group, Woody Matters. The group is part of a coalition called the Safe Patient Project that lobbies for patient protections.

Witczak recently spent several days in Washington meeting with the staffs of Minnesota Sens. Al Franken and Amy Klobuchar and Rep. Keith Ellison, among others. She raised concerns about the device and drug industry's free speech and off-label strategy, including the changes to the "intended use" law.

In addition to direct-to-consumer advertising, Witczak called the new FDA labeling proposal a "loophole that makes it worse for patients."

Even patient advocates like attorney Allison Zieve of Public Citizen, who believes cutting the sentence from the "intended use" law will do very little damage, questions why the FDA chose to try to implement the new rule in such 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."

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."

Jim Spencer • 202-383-6123