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# Sharfstein, Others Aim to Kickstart FDA Transparency
- URL: https://www.fdaweb.com/sharfstein-others-aim-to-kickstart-fda-transparency/
- Published: 2017-03-13T12:00:00.000Z
- Updated: 2026-09-14T22:11:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138187

Researchers from a number of institutions, led by former FDA principal deputy commissioner **Josh Sharfstein**, have developed a new “Blueprint for Transparency at FDA.” Sharfstein, now associate dean at Johns Hopkins Bloomberg School of Public Health, led FDA efforts to increase transparency during the early days of the Obama Administration. Back then, the agency identified a laundry list of transparency initiatives, and some of these moved forward, and others were never implemented, the researchers say in a just posted [*JAMA article*](http://jamanetwork.com/journals/jama/fullarticle/2612200?utm%5Fmedium=alert&utm%5Fsource=JAMAPublishAheadofPrint&utm%5Fcampaign=13-03-2017) outlining the blueprint.

The long belief is that greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products. “There is now broader recognition in the biomedical community of the value of transparency,” Sharfstein and the others write. “The European Medicines Agency has adopted policies to release enormous amounts of scientific information and analysis about regulated products. Several pharmaceutical and device companies now release data files in partnership with academic centers to permit independent analysis. Moreover, evidence has emerged that restrictive policies for sharing information on product decisions may be contributing to public confusion. In 2015, researchers at FDA found that companies often fail to disclose the agency’s reasons for not approving product applications. For example, of 7 cases in which FDA had cited higher mortality in patients receiving the active treatment under study, only 1 company press release mentioned this concern.”

The blueprint offers 18 recommendations in five principal areas. For example, it says FDA should disclose basic information about investigational notices, the filing of marketing applications, and the existence of clinical holds. It should also “disclose communications to companies when products are not approved, make public clinical and statistical reviews of products not approved or for which the marketing applications are abandoned or withdrawn, and make pooled data sets, masked and deidentified as appropriate, and FDA’s analyses of these data sets, available to the medical and research community through clinical data repositories,” the authors write.

Additionally, the blueprint says FDA should be more aggressive and correct misleading information in the public domain about safety and efficacy, for both approved and unapproved uses. “For example, in the recent cases of bupropion/naltrexone (Contrave) and eterlipsen (Exondys 51), the manufacturers released information that FDA knew to be misleading, but the agency waited for months for an opportunity to correct the record,” it says.

  
The authors note that FDA provided technical input on the recommendations, and they say all the recommendations can be implemented by the agency under existing statutes without additional action by Congress.