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Imagine a World Without FDA Guidelines. I Wonder If You Can

Imagine a World Without FDA Guidelines. I Wonder If You Can | Pharma Industry Regulation |

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.  

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