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Feb 14, 2017 03:44 PM IST | Source: CNBC-TV18

Pharma cos await Trump decision on FDA Commissioner: Steve Usdin

During his campaign, US president Donald Trump vowed to ease the burden of the healthcare industry in US by reducing taxes and government regulations. Two important decisions expected from the Trump administration is appointment of Food and Drug Administration (FDA) commissioner and drug price control.

During his campaign, US president Donald Trump vowed to ease the burden of the healthcare industry in US by reducing taxes and government regulations. Two important decisions expected from the Trump administration are appointment of Food and Drug Administration (FDA) commissioner and drug price control.

In conversation with CNBC-TV18, Steve Usdin, Senior Editor and Washington Editor of BioCentury, said Trump is likely to appoint FDA commissioner next week or the week after that.

“The relationship between regulated industry and the FDA is the most important thing for shaping the present and the future of pharmaceutical market in the United States. So it is a lot taken in who the administration appoints as the next FDA commissioner,” said Usdin.

The two candidates in the race for this post are Dr. Scott Gottlieb, former senior FDA official and Jim O'Neill, a Silicon Valley investor.

Dr. Scott Gottlieb has got lengthy experience at FDA and also at medicare services and he represents a kind of continuity in some senses but also he has an emphasis on pushing regulatory policies that are going to advance innovation. He is the choice of the drug industry.

Jim O'Neill, if he were to become the FDA commissioner. He will be the first FDA commissioner since late 1950s that didn't have either MD or PhD degree. He has made statements that are alarming for regulated industry and for public health groups about wanting to deregulate the FDA in ways that would lower the standards for efficacy and push drugs out based solely on safety data.

The second important thing to watch out for is what is going to happen on drug price controls. Usdin said that President Trump is of the opinion that drug prices in the United States are too high and there should be negotiation of drug prices that are paid by medicare and medicate.

Below is the verbatim transcript of Steve Usdin's interview to Ekta Batra & Prashant Nair.

Ekta: What is the near term or immediate measures that trump could roll out when it comes to healthcare in the US?

A: We are likely to see next week and if not next week the week after, which is going to be Trump's appointment of Food and Drug Administration (FDA) commissioner. The relationship between regulated industry and the FDA is the most important thing for shaping the present and the future of pharmaceutical market in the United States. So it is a lot taken in who the administration appoints as the next FDA commissioner.

The second important thing is what is going to happen on drug price controls. President Trump has been very adamant and said repeatedly that he thinks that drug prices in the United States are too high and there should be more competition and there should be negotiation of drug prices that are paid by medicare and medicate. All those things in details and how those work out are going to shape the entire market of pharmaceuticals in the United State, both for innovative products and for generic products.

Prashant: Could you talk to us about who the potential candidates for the FDA commissioner are and what are the big changes we can expect in regulation when the new person takes charge?

A: There are two people who have been discussed in the media. However, everything that is happening and coming swirling around President Trump and the White House right now, involves a lot of rumours and a lot of uncertainty, but the best information we have is that there are two candidates. One of them is Dr. Scott Gottlieb. He is a former senior FDA official. The second candidate is Jim O'Neill. He is a Silicon Valley investor. They really represent very different visions for what the FDA should be and what drug regulation should be.

Dr. Scott Gottlieb has got lengthy experience at FDA and also at medicare services and he represents a kind of continuity in some senses but also he has an emphasis on pushing regulatory policies that are going to advance innovation. He is the choice of the drug industry.

Jim O'Neill, if he were to become the FDA commissioner. He will be the first FDA commissioner since late 1950s that didn't have either MD or PhD degree. He has made statements that are alarming for regulated industry and for public health groups about wanting to deregulate the FDA in ways that would lower the standards for efficacy and push drugs out based solely on safety data.

For entire interview, watch accompanying video...

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