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Interview With Gottlieb: A Discussion on Biosimilars, Opioids and Transparency

Posted 20 April 2018 | By Zachary Brennan 

Interview With Gottlieb: A Discussion on Biosimilars, Opioids and Transparency

FDA Commissioner Scott Gottlieb spoke with Focus on Friday in a phone interview on the uptake of biosimilars in the US, generic drug labeling, the opioid crisis and FDA transparency. The interview was lightly edited for clarity.

Focus: You’ve spoken recently about biosimilars and cutting costs – what are the benefits of having an interchangeablity designation in the US, and do you think this designation could contribute to either the slower or faster uptake of biosimilars in the US?

Gottlieb: I think there will be interchangeable biosimilars on the market relatively soon, and the designation will increase the uptake of biosimilars. Plans, payers and other intermediaries will be more confident in making the switch to biosimilars, and we’re in the process of revising guidance on demonstrating interchangeability.

But look, we’re in the early innings of biosimilars, and anything we can do to educate providers and the public and help them understand FDA’s rigorous biosimilar review process will be helpful. I don’t think the situation on uptake or perception is too different from the early days of Hatch-Waxman [the 1984 law that allowed generic drugs to come to market], when there was a reluctance to use new generics. I think we’re seeing some elements of a similar phenomenon now – and as we see more familiarity – I would say to any patient and provider that they should have a lot of confidence in biosimilars. 

Focus: Moving over to the topic of generic drug labeling – you said previously that you thought FDA needed to bear more of the responsibility for updating older generic drug labels, but this has been a tricky issue and FDA has delayed the finalization of a rulemaking on generic labels – do you still think FDA bears this responsibility?

Gottlieb: We’ve put forth a proposal in the latest fiscal year budget for a substantial amount of Congressional funding to update older generic drugs. There are more than 1,000 generic drugs on the market for which there are no reference listed drugs, which means there’s no sponsor to update the drug’s label with new safety and efficacy information. So we’ve asked for the resources from Congress, as it can cost between $200,000 and $300,000 to update a label, and we’re hoping to start with oncology products, which can often provide lower-cost alternatives for expensive regimens.

Focus: More generally, has your thought process changed on any other specific issues that you may have viewed differently in your previous role in venture capital?

Gottlieb: [Laughing] I can barely remember what I did yesterday.

Focus: On the issue of the opioid epidemic, which you’ve singled out as a top priority, how much of this epidemic is a result of illegal foreign imports vs. products that are legally prescribed and purchased in the US?

Gottlieb: I think it’s impossible to quantify, but there’s no question that a lot of addiction is from lawful prescriptions. What I will say is that, whereas at one time a lot of new addictions were derived from people exposed in a clinical setting, more and more of the new addictions are people who were first exposed to opioids through street drugs. I think the majority are still people given an opioid from a lawful prescription, but it is tipping. And that should worry us all because the tools we have available to try to control the rate of new addiction from medically prescribed opioids are very different from how we would try to stop addiction from street drugs.

Focus: On transparency, you’ve been one of the more vocal FDA commissioners in recent memory – so how do you think your voice has contributed to the agency’s work and in shaping certain conversations?

Gottlieb: I think communication is a very important part of policymaking in Washington. Policy communication and the ability to articulate what you’re trying to achieve is an essential component to implementing successful policy. I take great care in trying to communicate not just a lot but very clearly and consistently and to make sure we’re offering the full context. I personally edit a lot of the documents, speeches and communications we put out.

And I feel like there are places where I felt it was important to change the narrative, particularly with respect to tobacco regulations, to reframe the debate not just on cessation but on nicotine. I think on drug pricing, it was important to focus some of the debate on the gaming of the system, where there’s been stalling of appropriate access to generic drugs. And with opioids, I thought it was important to reframe the debate around our role in reducing the rate of new addictions, and also to talk about the risks of not just the lawful use of opioids but also the illicit use of opioids.

Focus: Finally on transperancy, do you think there’s more information that FDA can proactively release, with complete response letters (CRLs) or otherwise?

Gottlieb: Yes, we can always do more. And you’re going to see us take steps to provide more information on drug reviews. We’re moving toward releasing more information at the time of approval – that will be a new document, and we’re piloting it right now and that will be coming in the next six to 12 months. Since we’re a government agency, people ought to know what we’re working on, what our opinions are. The CRL letters are one important vehicle and we’re looking at that, and I know it’s something people thought we would do quickly, but we need to do things with care, and be sure we’re focusing our resources carefully. I don’t know where we’ll end up, but it’s something we’re still committed to trying to look at.


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