Will deregulation trump clinical trial patient safety?

By Melissa Fassbender contact

- Last updated on GMT

Will deregulation trump clinical trial patient safety?

Related tags: Clinical trial, Clinical trial participants

The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.

The Executive Order​ (EO), released January 30, states: “it is important that for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process​.”

Overall, [the EO] seems very arbitrary and capricious​,” Kent Lloyd, a professor at the Department of Surgery, School of Medicine at the University of California told us.

Lloyd said this is the nature of the many Executive Orders being rolled out since Trump’s inauguration. “They’re either done too quickly or in an amateurish manner only for a political response​,” he said. “It’s gimmicky. It’s really not done in a very thoughtful way, but it’s done to get a political reaction​.”

Lloyd went on to suggest the EO could negatively affect the implementation of regulations designed to protect clinical trial participants, such as the updated Common Rule.

As Outsourcing-Pharma.com previously reported​, the rule seeks to enhance protections for clinical trial participants, while ensuring that the oversight system is not overly burdensome. The rule is slated to go into effect in 2018.

Fewer regulations, more costs?

Lloyd also pointed out that Government agencies would likely face higher costs when they introduce new regulations. 

Now, every new [regulation] that comes forward will have to be coupled with two or more being rescinded​,” Lloyd said, adding, “by definition, [the process] will increase overall effort, which will increase cost​.”

However, whether the impact of the rescinded regulations and their associated costs are actually a net benefit, Lloyd said, “we don’t’ know​.”

But certainly, just the mere process of doing this will cause more time and effort, and cost. I think it’s just not very well thought through to do it like this​.”

Legal challenge

Public Citizen, The Natural resources Defense Council (NRDC), and the Communications Workers of America have filed a legal challenge to the order.

The complaint states, “To repeal two regulations for the purpose of adopting one new one, based solely on a directive to impose zero net costs and without any consideration of benefits, is arbitrary, capricious, an abuse of discretion, and not in accordance with law​.”

According to the complaint, the EO causes injury by causing agencies “to delay, not issue, or repeal regulations that protect their concrete interests in order to comply with the Executive Order​.”

(Feature image: iStock/Berezko)

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