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# Califf Urges Harmonized Risk-Benefit Assessments Across Centers
- URL: https://www.fdaweb.com/califf-urges-harmonized-risk-benefit-assessments-across-centers/
- Published: 2017-01-20T12:00:00.000Z
- Updated: 2026-09-14T22:02:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137785

In his last role as FDA commissioner, **Robert Califf** has penned a *JAMA* [online article](http://jamanetwork.com/journals/jama/fullarticle/2599251?ref=fdaweb.com) calling for a harmonized risk-benefit assessment across the medical product Centers. “Realization of a harmonized benefit-risk framework across the agency will require firm commitment to evaluating cultural and scientific reasons for variation in decision making and to methodically identifying the organizing principles behind them,” writes Califf. “It will also require FDA to be open to iterative refinement of the framework, based on ongoing evaluation. Investment in this effort by future leadership will ensure that FDA continues to uphold crucial standards of safety and effectiveness from the premarketing space onward for the entire product lifecycle, while working to improve the consistency of decision making and spurring needed innovations for patients affected with acute and chronic illness.”

Califf believes that a shared understanding of the risk-benefit framework would reduce variability in decision making while promoting principled, transparent regulatory flexibility. “FDA has long recognized the need for such flexibility in accommodating variation across product categories and disease processes,” he writes. “However, to ensure that regulatory flexibility does not undermine standards of safety and effectiveness, it is essential that FDA clearly communicate the factors involved in determining how and when flexibility is to be applied across all product review processes.”

A harmonized approach would also benefit institutional knowledge, according to Califf, which could grow continuously over time and thus enable FDA review teams to better incorporate learning from previous experience and apply that understanding to current decisions. Moreover, he says, a “well-understood framework would also foster increased alignment between FDA and external stakeholders, including researchers, patients and their advocates, health care professionals and organizations, payers, and regulated industry. Transparent clinical decision making by FDA, including systematic analyses of uncertainties present at the time of approval and the likelihood that the benefit-risk balance may change over the product lifecycle, enables clinicians and patients to better tailor treatment choices. For regulated industry and insurance payers, a more predictable pathway for therapeutic development and for evaluating new uses of marketed products would reduce perceived regulatory risk and bolster a robust product pipeline, particularly for products that meet an unmet need or otherwise advance a significant public health interest.”

  
In order to track how a harmonized framework improves the quality and consistency of decisions, Califf recommends that decisions about new products and indications should increasingly refer to benefit-risk principles. “Second,” he continues, “product development plans should employ these considerations when critical decisions are made about applying for regulatory pathways such as accelerated approval or priority review vouchers, and when decisions are made about clinical trial designs. The increasing transparency of FDA documents and trial designs through mechanisms such as *ClinicalTrials.gov* should facilitate access to this information so that progress toward principle-based consistency can be tracked.”