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Regulatory Focus™ > News Articles > Female Senators Press FDA for Action on Sex-Based Differences and Clinical Trials

Female Senators Press FDA for Action on Sex-Based Differences and Clinical Trials

Posted 02 May 2014 | By Alexander Gaffney, RAC

A bipartisan group of female US senators is calling on the US Food and Drug Administration (FDA) to do more to ensure the equitable participation of women in clinical research.


When the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law in 2012, among its many provisions was Section 907. The section required FDA to publish a report "addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups-including sex, age, race and ethnicity-is included in product applications submitted to FDA."

The thinking of regulators and legislators was that if a trial does not adequately represent patients who will ultimately use a medical product, that product may be more or less effective or safe in some of those populations.

For example, if a statin drug would be used equally by both men and women, a clinical trial that included mostly men might hide some adverse events experienced exclusively by women.

Similarly, if a trial does not break out patient data by subgroup, it might not discover that a drug is less effective in patients of a particular sex, such as the case of Ambien.

FDA published its Section 907 report in August 2013. In it, the agency explained that in general, most companies were doing a good job at submitting data regarding sex-based differences in the performance of their products. Drug and biologics applications tended to do a better job at documenting the sex of their clinical trial participants and analyzing data, however.

However, not all clinical trials are large enough to account for sex-based differences with a sufficient degree of certainty, posing problems for regulators-and patients.

The Section 907 Action Report

But despite the assurances contained within the report, the senators said they remained "concerned about recent evidence that women still are not being adequately represented in clinical trials."

The answer, the senators wrote, lies with FDA's upcoming "Action Plan," which is also required under Section 907 of FDASAIA. By August 2014, FDA is supposed to publish an Action Plan containing:

  • recommendations, as appropriate, to improve the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling;
  • recommendations, as appropriate, on the inclusion of such data, or the lack of availability of such data in labeling;
  • recommendations, as appropriate, to otherwise improve the public availability of such data to patients, health care providers, and researchers; and
  • a determination with respect to each recommendation identified in subparagraphs (A) through (C) that distinguishes between product types referenced in subsection (a)(2)(B) insofar as the applicability of each such recommendation to each type of product.

"As the FDA works on the Action Plan required by Section 907 of FDASIA, we are writing to urge that this plan recommend clear and actionable strategies to improve the representation of women and minorities in clinical research, ensure that meaningful subgroup analyses are conducted, and make subgroup-specific clinical trial results publicly available and accessible," the senators wrote.

Senators: Three Points for FDA

In particular, the senators said they hoped for FDA to incorporate the following recommendations into its Section 907 Action Plan:

  • Require that representative proportions of women and minorities be included in industry-sponsored clinical trials comparable to what NIH required two decades ago.
  • Spell out the specific actions that FDA will take, in cooperation with industry stakeholders, in order to achieve meaningful subgroup-specific analyses for safety and efficacy, along with clear timelines for enforcement while ensuring that clinical trials are not unnecessarily disrupted and making the results transparent and publicly available.
  • Put in place a process for tracking and publicly reporting on the progress in implementing the Action Plan on a regular basis and for taking further action as needed to achieve equitable representation.

The signatories to the letter to FDA are Sens. Kelly Ayotte (R-NH), Tammy Baldwin (D-WI), Barbara Boxer (D-CA), Susan Collins (R-ME), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY), Kay Hagan (D-NC), Heidi Heitkamp (D-ND), Mazie Hirono (D-HI), Barbara Mikulski (D-MD), Lisa Murkowski (R-AK), Patty Murray (D-WA), Jeanne Shaheen (D-NH), Debbie Stabenow (D-MI) and Elizabeth Warren (D-MA).

The senators also sent a similar letter to the National Institutes of Health.

Letter to FDA

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