FDA must go easy on OTC drug makers—but who pays if safety slips?
H.R. 6868 — ACCESS Through OTC Innovation Act · Filed by Greg Landsman (D-OH) · Introduced Dec 18, 2025 · Referred to committee
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What it does
This bill amends FDA rules for over-the-counter (OTC) drugs to require the agency to use the 'least burdensome' approach when evaluating whether a drug is safe and effective, and to hold meetings with drug makers to advise them on what evidence they need to submit. The FDA must document these meetings and recommendations in writing. The primary beneficiaries are OTC drug manufacturers, who gain clearer guidance and a lighter regulatory touch; consumers may benefit from faster access to OTC drugs, but the bill does not explicitly strengthen safety oversight.
Why we flagged it
The bill's core function is to reduce regulatory burden on OTC drug manufacturers by mandating a 'least burdensome' standard and FDA-industry meetings. This is a deregulatory measure framed as consumer access, but the primary mechanism benefits industry compliance costs.
What the text implies
- The 'least burdensome' standard may create a regulatory floor below which the FDA cannot demand evidence, potentially allowing drugs with weaker safety data to reach consumers.
- Mandatory pre-submission meetings and written guidance could accelerate approval timelines but may also lock in industry expectations, making it harder for FDA to later tighten standards without appearing to breach its own guidance.
The full analysis lists 3 implications of this text.
Who stands to gain
OTC drug manufacturers; pharmaceutical companies with OTC portfolios; contract research organizations (CROs) advising on study design