Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), answered a few questions by telephone from Focus
on Friday afternoon. Below is a lightly edited transcript of the questions and answers.
- There was a recent announcement on reorganizing CDER but there’s also a reorganization of OND that’s ongoing – can you talk a little bit about this OND reorganization and how it might reshape the way investigational medicines are evaluated at CDER? What will be some of the practical changes that industry will see?
: I’m not sure it’s going to reshape things from the outside point of view, we are trying to flatten the organization, that’s what we’re proposing. There will be more disease identity divisions so you know what division is doing what disease, and we’ll have more specialists in that disease grouped together. We’re also proposing to centralize project management and that could impact industry because there will be a uniform process. We also have already started issuing guidances very rapidly and that’s part of a new plan to start an Office of Policy to get these guidances out on how to develop drugs. What’s FDA’s current thinking on endpoints and trials – and that’s what we’ve been hurrying through: Bulleted guidances on very specific topics.
- On the generic competition front, has FDA’s release of this list of off-patent drugs and decision to speed the approval of generics with limited or no competition actually resulted in any new competition? And are there other ways the agency is looking to boost generic drug competition in the future?
: We have now received inquiries from people who are interested once they have seen the list, but even if they’re marketing their drug overseas, it takes a while to get their marketing application together. It’s too early to see how much competition this will spur – others making the drug from scratch still have to do the development process and submit their application. It will take a little while since the publication of that list to see if it’s working.
GDUFA is our main way [to speed competition] as we’re publishing the product-specific guidances so everyone has a roadmap of how to get a generic to market once patents and exclusivity have cleared. Also, the generic review process, we don’t want to run backlogs anymore so our goal is to get more first-cycle approvals so companies can move on to other things. We’re doing a lot of work on that [ensuring applications are complete] and you’ll see more of that coming in the next few years.
- The ANDA approval process seems to have been transformed dramatically over the past few years, can you talk a little bit about what those changes were like to implement and whether there are any additional changes yet to come, especially in light of the OGD director moving on?
: We totally re-engineered the process, hired 1,000 new people, set up new structures and approved or tentatively approved over 1,000 applications in 2017. But we want to keep this at a steady state. We also want to try to better structure the application and get people to understand better what they need to send in so we don’t have to ask them a lot of questions. You’ll be seeing improvements in the process over the next several years to get it more efficient. The previous changes were a revolution, but these newer changes will be more continuous changes.
- On the biosimilar front, the US is still behind its EU counterparts in terms of approvals – how is CDER helping to bridge this gap? How difficult has it been to inform and educate physicians that might have questions about biosimilars? And have there been difficulties in educating clinicians on interchangeable biosimilars?
: We have fewer biosimilars but they have drugs approved as biosimilars that have been approved as NDAs [new drug applications] here. And they’ll move over to be biosimilars or move over and be biologicals in the coming years. Also, Europe’s enabling legislation for biosimilars occurred many years ahead of the US. We can’t just take what’s done in Europe and move it over here because there are different reference standards.
There’s a lag for the manufacturers and a number have signed up on how to prove biosimilarity and we’ve done a lot with the healthcare system in terms of informing and educating physicians. But they didn’t want to be educated on something they couldn’t access. More recently, as biosimilars have been approved, doctors are becoming more interested in learning about them.
The interchangeable issue for the clinician – you have to realize they don’t like the interchangeable part because of control. They’re willing to write [a prescription] for a biosimilar but they don’t like the idea that it could just be switched. I think other parties would prefer everything be interchangeable and be switched but we have to walk a fine line and educate clinicians enough so they’re not writing do not substitute. For the clinical community, they’re more comfortable where we are now and where they have control.
- And finally, drug shortages have been an issue for years – what are the chances FDA allows certain imports on a wider basis to help relieve these shortages?
: It’s a case by case basis. Whenever a shortage is ameliorated, we don’t want to undermine the manufacturers in the United States. The imports are a stop-gap measure and we try to encourage such manufacturers to enter the US market.