FDA 2027 Budget Tightens the Noose on Crooked Compounders
An important little regulatory morsel in the Health & Human Services fiscal year 2027 budget for FDA. On page 16. under the heading “Legislative Proposals” Comes this important statement (italics added for emphasis):
"Holding Firms Accountable Using Misleading Advertising to Drive Profits at the Expense of Consumers
This proposal would update FDA’s authorities with respect to direct-to-consumer (DTC) advertising. Specifically, this proposal would deem a drug to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352) if a DTC drug advertisement lacks fair balance and creates a misleading impression regarding FDA approval, the scope of the FDA-approved indication(s) and the limitations of use, or the drug’s efficacy and benefits, including by making or suggesting overstated representations that are not supported. It would also update the FD&C Act to clarify that a compounded drug is deemed to be misbranded if an advertisement’s representation is false or misleading or creates a misleading impression by failing to clearly and prominently disclose that the FDA has not approved or evaluated these products for safety, effectiveness, or quality prior to marketing; representing or suggesting the compounded drugs are safe and effective without any evidence; making misleading comparative claims to a particular FDA-approved drug or class of drugs; misrepresenting the data available about the compounded drug or its active ingredients for particular indications based on clinical trials of FDA-approved drugs containing the same active ingredients; or omitting risk information or otherwise failing to provide fair balance. FDA needs additional authorities to more effectively address DTC advertising that lacks fair balance and is frequently misleading and confusing to consumers and patients”
Whether you identify as a HIMS or a HERS – this statement is an unambiguous shot across the bow to compounders and marketers of their violative products. The message is clear: “Cut the crap!
And you know who you are.
An important little regulatory morsel in the Health & Human Services fiscal year 2027 budget for FDA. On page 16. under the heading “Legislative Proposals” Comes this important statement (italics added for emphasis):
"Holding Firms Accountable Using Misleading Advertising to Drive Profits at the Expense of Consumers
This proposal would update FDA’s authorities with respect to direct-to-consumer (DTC) advertising. Specifically, this proposal would deem a drug to be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352) if a DTC drug advertisement lacks fair balance and creates a misleading impression regarding FDA approval, the scope of the FDA-approved indication(s) and the limitations of use, or the drug’s efficacy and benefits, including by making or suggesting overstated representations that are not supported. It would also update the FD&C Act to clarify that a compounded drug is deemed to be misbranded if an advertisement’s representation is false or misleading or creates a misleading impression by failing to clearly and prominently disclose that the FDA has not approved or evaluated these products for safety, effectiveness, or quality prior to marketing; representing or suggesting the compounded drugs are safe and effective without any evidence; making misleading comparative claims to a particular FDA-approved drug or class of drugs; misrepresenting the data available about the compounded drug or its active ingredients for particular indications based on clinical trials of FDA-approved drugs containing the same active ingredients; or omitting risk information or otherwise failing to provide fair balance. FDA needs additional authorities to more effectively address DTC advertising that lacks fair balance and is frequently misleading and confusing to consumers and patients”
Whether you identify as a HIMS or a HERS – this statement is an unambiguous shot across the bow to compounders and marketers of their violative products. The message is clear: “Cut the crap!
And you know who you are.
