Trump’s “one in, two out” regulatory order threatens FDA, Obama Cures Act

pharmafile | January 31, 2017 | News story | Manufacturing and Production, Sales and Marketing FDA, Trump 

An executive order signed by President Donald Trump on Monday has caused concern in the US pharma industry and beyond over its potential impact on the country’s regulatory system.

Designed to benefit small businesses, the order calls for government agencies to pull two regulations for every new regulation they implement, and enforces a strict requirement for the cost of all new regulations to be “no greater than zero” unless authorised by the Office of Management and Budget (OMB) or required by law.

White House press secretary Sean Spicer called the order “the most significant administrative action in the world of regulatory reform” since the Reagan administration.

However, critics of the move have been quick to point out that an abundance of regulations is not the core problem with the US system; many serve little purpose, either implementing spending constraints, correcting errors, reducing burdens or even simply deregulating.

Industry figures are also alarmed by the lack of detail provided in the order, leaving them unsure of how exactly it will come into effect or how it will impact a public health-minded organisation like the FDA. Foremost among these concerns is the fact that, because of the nature of the FDA and its breadth of the legislation it enforces, for it to enact a new regulation it would need to cut two potentially completely unrelated ones, creating an almost one step forward, two steps back approach.

The order even affects FDA guidance documents, which could have huge implications on the pharma companies which depend on said guidance when it comes to the authorisation of new products.  

This all comes only a week after Trump’s call for a federal hiring freeze which also caused concern over the potential pressures it could place on the FDA, an organisation already suffering from tight deadlines and understaffing.

Perhaps the biggest impact of the order is how it could affect Obama’s 21st Century Cures Act, a $6.3 billion bill signed by the former president in December dedicated to expediting the approval of new medical treatments. The 1,000 page document is heavily connected to the FDA, and Trump’s regulatory shake-up could create sizeable obstacles for it to overcome in its implementation.

The implementation of the tenets of this new order across federal government is to be reviewed by the director of the OMB.

Matt Fellows

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