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By Bronwyn Mixter
Nov. 30 — The FDA is extending the comment period for a proposed rule that would amend the agency's regulations defining “intended use” for drugs and medical devices, according to a notice published Nov. 30 in the Federal Register (80 Fed. Reg. 74,737).
The proposed rule described the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device or a combination drug/device product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the notice said. The proposed rule was published Sept. 25 (80 Fed. Reg. 57756).
As part of the September proposal, the agency said it would change its rules to reflect that it doesn't regard “a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that such product was being prescribed or used by doctors for such use.”
The agency said the rule changes wouldn't reflect a change in FDA's approach regarding evidence of intended use for drugs and devices. “These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption,” the agency said.
Comments on the proposed rule were due Nov. 24. They are now due Dec. 30, under Docket No. FDA–2015–N–2002. The agency said it was taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
The Family Smoking Prevention and Tobacco Control Act, a 2009 law, amended the FD&C Act to provide the FDA with the authority to regulate tobacco products, the FDA said. Excluded from the definition of a tobacco product is any article that is a drug, device or combination product.
“Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device or combination product, and the circumstances under which it would be regulated as a tobacco product, FDA is initiating this rulemaking to provide clarity regarding our interpretation of the drug and device definitions in the FD&C Act with respect to products made or derived from tobacco,” the agency said in the Sept. 25 notice.
Under the proposed rule, a product made or derived from tobacco would be regulated as a drug, device or combination product in two circumstances:
The proposed rule also attempts to clarify remaining circumstances where a product would be or could be regulated as a tobacco product, the agency said.
The FDA said it may look to “any relevant source,” including but not limited to the product's labeling, promotional claims and advertising in order to determine a product's intended use. For example, the agency said it may take into account any claim or statement made by or on behalf of a manufacturer that explicitly or implicitly promotes a product for a particular use.
The agency said that to establish a product's intended use, it isn't bound by the manufacturer or distributor's subjective claims or intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence.
“In the context of medical products, generally, circumstantial evidence often ensures that FDA is able to hold accountable firms that attempt to evade FDA medical product regulation by avoiding making express claims about their products,” the agency said. “FDA has previously stated, however, the agency would not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on the firm's knowledge that such product was being prescribed or used by doctors for such use.”
The proposed rule isn't expected to impose significant additional costs on manufacturers who make products made or derived from tobacco, or on drug and device manufacturers generally, the agency said.
In comments submitted before the due date was extended, the University of California, San Francisco's Tobacco Center of Regulatory Science (UCSF TCORS) said the proposed rule doesn't go far enough and the FDA “should also consider claims suggesting that a tobacco product will provide the same ‘satisfaction' or nicotine hit as conventional cigarettes and/or provides an alternative way to get the same ‘pleasure of smoking' to fall within its drug and device authority.”
The center also said companies shouldn't be permitted to market the physically identical or similar tobacco products as both medicinal and recreational. “In such cases, FDA should regulate both products under its drug/device authority to prevent confusion for consumers,” the center said.
“FDA must be vigilant in monitoring the market to ensure that companies do not try to introduce and market physically identical or similar tobacco products that differ only in name and/or packaging or nearly identical products under both its Center for Drug Evaluation and Research (CDER) and its Center for Tobacco Products (CTP) by making cessation or therapeutic claims about one of the products (causing it to be regulated as a drug/device) and making recreational claims about the other product (causing it to be regulated as a tobacco product),” UCSF TCORS said. In addition, the UCSF center said that “no tobacco product should be permitted to use CTP's substantial equivalence pathway if the predicate product to which it is being compared entered the market through CDER. Any product that is substantially equivalent to a product regulated by CDER must also be regulated by CDER.”
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