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How Donald Trump will impact the FDA

A new president is always big news, sparking discussion regarding new policies and initiatives. The recent election, which resulted in a win for Donald Trump, has created media frenzy like never before. President-elect Trump has already voiced his dislike of Obamacare and the Affordable Care Act (ACA), pledging to repeal it as a priority once he takes office in January.


How far he will go with this is, of course, the question on everybody’s lips.

FDA guidelines

When it comes to how he will move forward with the FDA, for which he has shown plenty of criticism in the past, things are less clear. Describing inspections and regulations as ‘overkill’ that serve only to harm the US economy, Trump was subject to considerable criticism. Given that the FDA also oversees the drug industry, it looks likely that he might be tempted to lower the bar when it comes to drug approvals.

Trump spoke of some 4,000 drugs waiting to be approved and the need to speed up the FDA 510k clearance process, perhaps cutting out ‘red tape’ through more initiatives such as fdathirdpartyreview.

When he cites 4,000, it is probable that he is including not only chemical entities that are new to the market but also already approved drugs for which there has been an application to use them in new situations and generic drug approvals.

Finding the middle ground

As with the majority of policies, Trump will no doubt come to very quickly realise that regulation is required to offer the general public the necessary level of protection; however, he is likely to take some steps in line with the above. These might include:

– Lowering the bar for generic drug approval, which will serve to drive completion and keep cost down.
– In cases such as Eteplirsen – used in the treatment of Duchenne muscular dystrophy, where there are few or no alternatives for patients – orphan drugs may see approval more easily. This will, of course, receive the thumbs up from advocates of those with rare diseases.
– Off-label use of pre-approved drugs may see fewer restrictions.

The FDA is very likely to raise concerns around these measures, of course, especially when it comes to the American public potentially being put at risk.

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