Emma Gallimore Mar. 16, 2016, 1:38pm


WASHINGTON (Legal Newsline) – Concern still swirls around the rule change proposed by the U.S. Food and Drug Administration that would remove an existing regulation on determining intended use for drugs and devices.

The manner of its announcement caused as much outcry as the regulation itself. The FDA inserted the 245-word proposed regulation into a 10,000 word document on tobacco product regulations. This proposal would apply not just to tobacco products, but to drugs and devices in general.

“I think that it is a very poor practice for the agency to include a change to important, long-standing rules affecting drugs and devices in a rulemaking that people who focus on drugs and devices are unlikely to be following,” Allison Zieve, director of the Public Citizen Litigation Group, told Legal Newsline. “Regardless of whether the proposed change is major, it should be proposed in a notice that people will understand addresses drugs and devices.”

The title of the document is “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding Intended Uses” and it was released in September 2015.

“The full title of the notice includes the information, but in a later part of the title that could easily lead people to think that the proposed rule addressed only tobacco products,” Zieve said.

In addition to the manner of the announcement, critics also are concerned about the effect the proposed changes may have on patients.

Currently, the regulations state: “But if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug/device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.”

The proposed regulation would omit that sentence, effectively releasing manufacturers from the obligation to provide labeling for uses not sanctioned by the manufacturer. An FDA spokeswoman recently told the Star Tribune this part of the intended use regulation is not being applied and so deleting it from the law will have little effect.

However, some critics have raised fears that the change could make it tougher to hold manufacturers accountable for harms caused by their products.

“The concern would be that companies might argue that the deletion means that the FDA has a narrower view of adequate labeling than before and that this view should preempt state law under which labeling must be adequate to warn of risks posed by uses of which the manufacturer is aware,” Zieve said.

Zieve said she did not think this argument would stand up in court.

The proposed regulation is part of a greater debate surrounding FDA regulations. A Senate panel led by U.S. Sen. Patty Murray, D-Wash., examined FDA oversight as part of a medical device case and found multiple reporting and regulatory issues. Murray and other federal lawmakers are considering possible regulations changes that could include more labeling on medical devices, a direct contradiction to the proposed FDA regulation.

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