PATIENTS' FDA Act

[AI summary unavailable — showing source text] Promoting Accountability, Transparency, Innovation, Efficiency, and Timeliness at FDA Act of 2012 or the PATIENTS' FDA Act - Requires the Secretary of Health and Human Services (HHS) to develop a strategy and implementation plan for advancing regulatory science for medical products in order to promote the public health and advance innovation in regulatory decision making. Expands reporting requirements related to Food and Drug Administration (FDA) progress reports, generic drugs, and biosimilar products. Requires the Secretary to: (1) document the scientific and regulatory rationale for any significant decision regarding drugs, biologics, or medical device applications; and (2) review all regulations and guidance of the FDA with respect to human medical products to ensure consistency with the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) and specified regulatory principles. Amends the FFDCA to require the Secretary to assess the safety and effectiveness of a medical device from the perspective of a reasonable patient in the intended use population. Sets forth provisions governing determinations by the Secretary of a lack of reasonable assurance of safety of a dev…