Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 228

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 228
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 and health care providers over treatments prepared in compounding entities;

•the success or failure of other FDA-approved bioidentical hormone products and FDA-approved non-hormonal products for VMS;

•new information supportive or against the use of hormones in menopause; and

•availability and extent of third-party payor coverage and reimbursement for DARE-HRT1 and out-of-pocket cost for patients.

Depending upon the direction of the factors above, a commercial market for DARE-HRT1 may develop more slowly than expected, or not at all, and our business, financial condition, results of operation and prospects could be hurt as a result.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses for prescription medical products. If we or any commercial collaborator is found or alleged to have improperly promoted any of our products for off-label uses, we may become subject to significant liability, including fines, penalties or injunctions, and reputational harm.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription medical products. In particular, a product may not be promoted for uses that are not approved by the FDA (i.e., off-label uses), as reflected in the product’s approved or cleared labeling. Promotional labeling and advertising for any of our drug product candidates that receive marketing approval, must be submitted to FDA at the time of first use and the agency actively solicits reports from health care professionals about improper promotional claims or 

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activities by the drug manufacturer or distributor. Medical device promotion and advertising are subject to similar off-label restrictions, although without the same requirement to submit promotional materials to FDA at the time of first use. Both prescription drug and medical device promotional materials must present a fair balance between the product’s effectiveness and the risks associated with its use, and must be truthful and not misleading.

If we or a commercial collaborator is alleged or found to have promoted a product for any off-label use, we may become subject to significant liability and reputational harm. The federal government has levied large civil and criminal fines against companies for alleged improper medical product promotion and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Other enforcement authorities may also take action against a company for promoting an off-label use of a prescription medical product, which could result in penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. See