10
Feb2017

This week’s Research Ethics Roundup covers President Trump’s call for removing a majority of FDA regulations, the argument for calling for efficacy data before human research begins, USDA’s decision to remove Animal Welfare Act records, and FDA’s case for conducting phase three testing.

Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated
Zachary Brennan reports for Regulatory Focus on President Trump’s remarks to a group of pharmaceutical industry leaders. The President said he would be “cutting regulations at a level no one has ever seen before,” citing foreign competition as one of his primary concerns. Critics point out that companies cannot afford to bypass the lucrative US market, which is the largest in the world.

Consider Drug Efficacy Before First-in-Human Trials
In this Nature commentary piece, Jonathan Kimmelman and Carole Federico argue that regulators and IRBs should ask for more evidence on a drug’s efficacy before allowing human trials to begin. They also argue that study sponsors should submit all unfavorable results from prior research with animals and outcomes from related trials to an IRB. As part of this submission, the authors contend, sponsors should provide a signed statement that this evidence is comprehensive and unbiased.

USDA Abruptly Purges Animal Welfare Information From its Website
In this Washington Post article, Karin Brulliard reports that the US Department of Agriculture’s (USDA) decision to remove enforcement records and inspection reports involving research animals and institutions such as zoos is drawing criticism. The USDA argued the move was necessary because of privacy concerns and points out that the aforementioned records and reports can be obtained through Freedom of Information Act Requests. However, opponents of the changes argue such requests can take years to be processed.

FDA Highlights the Importance of Confirmatory Studies
In this Applied Clinical Trials article, Jill Wechsler examines a recent FDA report: “22 Case Studies Where Phase 2 and Phase 3 Trials had Divergent Results.” The report shows that in 22 instances, phase three trials were necessary to show that certain medical devices, drugs, and vaccines did not meet safety and efficacy standards. The FDA has been facing increasing pressure to allow sponsors to abandon phase three testing.

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