Trumps new regulatory EO includes guidance docs, could create hurdles for FDA

A new executive order signed today would require all government agencies to eliminate 2 regulations for every new regulation instituted – including guidance documents.

The new order could have a significant impact on the FDA, as it applies to all agencies other than those related to the military and national security, or those specifically exempted by the Office of Management and Budget.

The EO, in its current state, also applies to FDA guidance documents, which will be a significant problem for medical device firms who use such documents to to conform to FDA standards and understand how the agency interprets the law.

How the executive order would operate has yet to be understood, especially considering that most regulations are not connected in terms of functionality or implementation. However, as it stands, the order could effectively require the FDA, and other public health agencies, to cut 2 regulations every time they place a new one, even if those regulations are entirely unrelated.

Any choices for elimination or new regulations would also have to pass scrutiny from the White House, and would be limited by the $0 budget set in the EO.

The order could have a significant impact on the recently passed 21st Century Cares Act, which includes language for developing a new breakthrough device pathway and other implementations what would be subject to the 1-in-2-gone rule. The order will also likely impact the reauthorization of the FDA’s user fee programs, which is slated for September.

On Jan 14, former President Obama signed the 21st Century Cures Act into law, the last step for the bill which had been 2 years in the making.

A week earlier, the U.S. Senate voted 94-5 to pass the 21st Century Cures Act, which sent the measure to President Barack Obama.

The U.S. House voted to pass the healthcare measure by a vote of 392-26 last week. Supporters of the bill said it will spur medical innovation by speeding up the regulatory process for device-makers and pharmaceutical companies, while expanding access to mental health treatment and battle the ongoing opioid epidemic. But critics, like Sen. Elizabeth Warren (D-Mass.) and Sen. Bernie Sanders (D-Vermont), have said the bill gives hand-outs to the pharmaceutical industries and cuts public health programs.

The $6.3 billion measure was sponsored by Rep. Fred Upton (R-Michigan) and authorizes $4.8 billion for the National Institutes of Health and $500 million to the FDA. The bill includes provisions which allow clinical trials for devices and drugs to be designed with fewer patients and simpler goals.

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