US President Donald Trump recently chose an adviser to a large pharmaceutical company to lead the country’s drug regulation agency. Scott Gottlieb – who reportedly sits on the boards of several small drug companies and is an adviser to GlaxoSmithKline – is expected to introduce greater flexibility to the evidence standards used by the Food and Drug Administration (FDA) to evaluate the benefit and risks of new medicines. This is consistent with Trump’s message to pharmaceutical executives in January, when he said: We’re going to be cutting regulations at a level nobody’s ever seen before […] You’re going to get your products – either approved or not approved – but it’s going to be a quick process. Trump’s views might seem extreme but his comments are not entirely out of step with the views of previous US governments. An example is the 21st Century Cures Act, which was passed late last year after heated debate. This aims to speed up innovation and the search for cures by setting lower thresholds for evaluating the safety and effectiveness of new medicines. The Act is an addition to a range of expedited programs the US already had in place for some time to permit drugs to enter the market based on less robust evidence than traditionally required. So Gottlieb already has the tools to make it easier to get drugs onto the market in the US. But what does this mean for Australia? A recent comment piece published in the journal Nature noted that weaker regulatory standards in the US can impact health everywhere. One reason is companies will have far less incentive to run the expensive high-quality trials needed to inform decision-making if the biggest market in the world does not demand it
