JANUARY 30, 2017
Trump order on regulations could create hurdles for FDA, Cures Act
https://www.statnews.com/2017/01/30/fda-regulations-executive-order-trump/
ASHINGTON — President Trump on Monday signed an executive order directing federal agencies to cut two regulations for every new one that they adopt, a move that could have significant implications for the Food and Drug Administration.
Trump, who vowed throughout his campaign to ease the burden of government regulations in order to promote innovation, pledged at the signing ceremony that the order would be “the biggest such act our country has ever seen.”
“There will be regulation, there will be control, but it will be normalized control,” he said.
Successive Republican administrations have sought to eliminate government regulations, though Trump’s order appears to be more sweeping in fashion that other orders issued the the past. White House press secretary Sean Spicer described it as “the most significant administrative action in the world of regulatory reform” since the Reagan administration.
As with the executive order last week on a federal hiring freeze, the Trump administration provided few details on how, precisely, the latest one would be implemented. That absence of immediate detail could create grave anxiety at the FDA, which administers federal law on food safety, drugs, cosmetics, and more.
In particular, the order could have consequences for the legions of lawmakers, lobbyists, and patient advocates who are seeking to implement the 21st Century Cures Act, the hard-won legislation that was among the last bills signed into law by President Barack Obama.
The law is designed to speed the introduction of new medical treatments by accelerating some FDA approval processes and boosting federal funding. The nearly 1,000-page document lays out, in great detail, how the FDA should proceed.
The Cures Act, for instance, directs the FDA to establish a “breakthrough device pathway” for the approval of medical devices, which will build on the existing priority review device program. Along the same lines, the agency is charged with creating a new pathway for biomarkers and other drug development tools, to help reduce the time it takes to develop drugs.
The executive order stressed that agencies must ensure that the “cost of planned regulations be prudently managed and controlled through a budgeting process.” For fiscal 2017, the cost of all new regulations, including repealed regulations, is to be “no greater than zero,” unless otherwise required by law or approved by the Office of Management and Budget.
Some experts say the problem with the current regulations is not necessarily that there are too many of them — but that there are some that simply are unnecessary.
“As presidents from Ronald Reagan to Barack Obama have recognized, the real question is whether regulations, whether new or old, are justified,” Harvard Law School professor Cass Sunstein, who served as regulations czar for more than three years in the Obama White House, said in an essay for Bloomberg News published in late November.
Some regulations are actually deregulations, which reduce existing burdens, he said. Others implement spending programs, or are technical amendments, sometimes correcting errors.
Michael Gaba, a life science partner in Holland & Knight, said Trump’s executive order was broadly written and gives the director of the White House Office of Management and Budget latitude in how to implement it. (Trump’s nominee for the post, Mick Mulvaney, is currently being considered by the Senate.)
“There is discretion on how you evaluate the cost of old and new regulations,” Gaba said. “Before we can really analyze this we need to see what the OMB director says.”
Sheila Kaplan can be reached at sheila.kaplan@statnews.com
Follow Sheila on Twitter @bySheilaKaplan
Trump order on regulations could create hurdles for FDA, Cures Act
https://www.statnews.com/2017/01/30/fda-regulations-executive-order-trump/
ASHINGTON — President Trump on Monday signed an executive order directing federal agencies to cut two regulations for every new one that they adopt, a move that could have significant implications for the Food and Drug Administration.
Trump, who vowed throughout his campaign to ease the burden of government regulations in order to promote innovation, pledged at the signing ceremony that the order would be “the biggest such act our country has ever seen.”
“There will be regulation, there will be control, but it will be normalized control,” he said.
Successive Republican administrations have sought to eliminate government regulations, though Trump’s order appears to be more sweeping in fashion that other orders issued the the past. White House press secretary Sean Spicer described it as “the most significant administrative action in the world of regulatory reform” since the Reagan administration.
As with the executive order last week on a federal hiring freeze, the Trump administration provided few details on how, precisely, the latest one would be implemented. That absence of immediate detail could create grave anxiety at the FDA, which administers federal law on food safety, drugs, cosmetics, and more.
In particular, the order could have consequences for the legions of lawmakers, lobbyists, and patient advocates who are seeking to implement the 21st Century Cures Act, the hard-won legislation that was among the last bills signed into law by President Barack Obama.
The law is designed to speed the introduction of new medical treatments by accelerating some FDA approval processes and boosting federal funding. The nearly 1,000-page document lays out, in great detail, how the FDA should proceed.
The Cures Act, for instance, directs the FDA to establish a “breakthrough device pathway” for the approval of medical devices, which will build on the existing priority review device program. Along the same lines, the agency is charged with creating a new pathway for biomarkers and other drug development tools, to help reduce the time it takes to develop drugs.
The executive order stressed that agencies must ensure that the “cost of planned regulations be prudently managed and controlled through a budgeting process.” For fiscal 2017, the cost of all new regulations, including repealed regulations, is to be “no greater than zero,” unless otherwise required by law or approved by the Office of Management and Budget.
Some experts say the problem with the current regulations is not necessarily that there are too many of them — but that there are some that simply are unnecessary.
“As presidents from Ronald Reagan to Barack Obama have recognized, the real question is whether regulations, whether new or old, are justified,” Harvard Law School professor Cass Sunstein, who served as regulations czar for more than three years in the Obama White House, said in an essay for Bloomberg News published in late November.
Some regulations are actually deregulations, which reduce existing burdens, he said. Others implement spending programs, or are technical amendments, sometimes correcting errors.
Michael Gaba, a life science partner in Holland & Knight, said Trump’s executive order was broadly written and gives the director of the White House Office of Management and Budget latitude in how to implement it. (Trump’s nominee for the post, Mick Mulvaney, is currently being considered by the Senate.)
“There is discretion on how you evaluate the cost of old and new regulations,” Gaba said. “Before we can really analyze this we need to see what the OMB director says.”
Sheila Kaplan can be reached at sheila.kaplan@statnews.com
Follow Sheila on Twitter @bySheilaKaplan