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Regulatory uncertainties abound with presidential two-for-one order

Tuesday, February 21, 2017

The Trump administration seems to be serious about reducing the cost and burden of regulations. The question observers are asking is how those efforts will eventually shake out.

One the administration’s latest initiatives is an executive order signed by the President that would require federal agencies, such as the FDA, to eliminate two regulations for every new one it wants to issue. The order also mandates that the cost of a new regulation should be offset “to the extent permitted by law.”

The reaction to the executive order appears to be one of uncertainty concerning how the order will work in reality. For example, while the order imposes a limit on regulations, how is “regulation” defined?

“How is it going to be interpreted?” asked James Boiani, senior counsel in the Health Care and Life Sciences practice of Epstein Becker & Green P.C. in Washington, D.C. “From what I’ve read so far, it seems like it could encompass guidance and regulations. With regard to the removal of the regulations, we could be talking about removing sections of regulations or whole parts. I think the devil will be in the details in terms of how it will be implemented.”

Much depends on who the new FDA commissioner is and what his or her focus will be, Boiani observed. Stephen Ostroff, M.D., is the agency’s acting commissioner until a new commissioner is nominated and confirmed.

“We certainly support the administration’s desire to reduce regulatory burdens,” said Cami Gearhart, JD, CEO of Quorum Review IRB in Seattle. “But in the area of drug development, it is also critical to preserve protections of clinical trial subjects and, ultimately, the consumers of new drugs.”

Gearhart said that one area of concern is the impact the executive order will have on the “Common Rule” or the Federal Policy for the Protection of Human Subjects.

“Earlier this year, we were encouraged to see many years of work come to fruition through changes in the Common Rule, the regulation that governs the ethics review of federally funded research,” Gearhart said. “The final regulation should substantially reduce regulatory burdens on both clinical and non-clinical research without sacrificing oversight of participant protections. We hope we don’t lose these reforms in the two-for-one environment.”

There’s also a question how the two-for-one executive order will affect the implementation of the 21st Century Cures Act, which, among other things, is designed to expedite the approval of drugs and devices and get them to consumers faster.

“The new 21st Century Cures Act directs the FDA to develop regulatory changes to reduce burdens on the drug development process, while preserving protections for trial subjects and consumers,” said Gearhart. “We hope the FDA will be able to pursue these regulatory initiatives in this new two-for-one environment.”

Boiani pointed out that while it remains unclear how the executive order will be implemented, regarding the 21st Century Act, it is something “the FDA is going to need to address right off the bat in terms of how it is going to interpret the executive order.”

For example, he noted that under the act there is a requirement that the FDA revise a section of its 2008 Guidance Document, “Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”

“The FDA is statutorily mandated to issue a new draft within a year,” said Boiani. “If that is covered by the executive order, that’s just one example that requirements under [the 21st Century Cures Act] that have been put in place will push the FDA to interpret this sooner than later.

“In the near term, I think things at the FDA will be in a holding pattern,” he added. “But, if it drags on, the FDA is going to have to move forward under the acting commissioner’s guidance to start interpreting this because there won’t be enough time otherwise.”

A suit filed in the U.S. District Court for the District of Columbia by Public Citizen, the Natural Resources Defense Council and the Communications Workers of America could also complicate matters.

The suit asks the court to block the order and alleges that compliance with the order would violate the Administrative Procedure Act and other statutes under which federal agencies operate.

“If implemented, the order would result in lasting damage to our government’s ability to save lives, protect our environment, police Wall Street, keep consumers safe and fight discrimination,” said Public Citizen President Robert Weissman in a statement.

On a broader scale, Boiani said that the new administration’s focus on relieving regulatory burdens and encouraging innovation should be welcomed by the clinical trials industry.

“I suspect what you might see is more clinical trials being conducted,” he said. “With greater flexibility at the FDA—which is a greater possibility with this administration—you’re potentially going to encourage pharma companies that might otherwise abandon products at earlier [trial] phases to move forward knowing that they might have a better opportunity of developing a path forward, or just have a better chance of approval.”

“The intention of the executive order is clear and that’s to reduce the regulatory burden,” said Boiani. “How it is implemented is going to be another matter.” 

 

This article was reprinted from Volume 21, Issue 07, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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