Pharma Industry Concerned About Trump’s Push to Radically Change FDA

by John Kizer | February 20, 2017 1:06 pm

There have been lots of changes and many people have been worried about the new President’s approach to government. In fact, Mr Trump has been looking to radically change the FDA to make it less robust. Trump’s idea to roll back the regulations by 75% means that executives from the major drug companies are worried their insurance coverage costs will


Looser Regulations Could Damage Drug Industry

The drug companies are currently criticised for the high costs of their drugs, but increases in insurance might push them even higher. Trump is looking for ways to fast-track the FDA approval process for new drugs, but many people are concerned this will create a less robust review process and that drugs that are not ready might be released to the public.

There has been some thought that the FDA is too restrictive, but there does need to be a strong review process to ensure the drugs proposed not only work but are also safe in the long term. There has to be a certain amount of waiting while the review process takes place. Insurers need to be willing to pay for the product, and with looser tests, they might be reluctant.

Worries Over Insurance and Safety

There were worries over what Trump[1] might actually do once elected. It seems this concern over changes to the FDA regulations is the latest issue to cause controversy and doubt, with the main worries being over insurance and safety.

One alternative is to speed up the process for generic drugs but keep higher testing levels for novel drugs, which need more rigorous testing. It is vital that drugs have proper clinical tests. In fact, many companies ask how long does it take to get a FDA 510k approved. But it need not take so long as months or years. Drug companies can use experts such as[2] to get their drug fast-tracked through the process while still having all the proper clinical trials.

Although the drug companies are keen to speed up the review process for their new drugs, it is also important that insurers are not put off by looser controls and that clinical trials continue at the proper level of rigour. It seems that a fast-track company could be a better option than Trump’s proposals for looser regulation.

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