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  1. Speeches by FDA Officials


Event Title
Remarks at the NCCN-ASCO Workshop
November 8, 2018

Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
NCCN/ASCO Workshop
Alexandria, Virginia

(Remarks as prepared for delivery)

I want to thank you for the opportunity to address this meeting, and for the chance to acknowledge the important effort you’re undertaking.

We know that there’s far too much use of opioid drugs.

There’s still too much indiscriminate prescribing.

And there’s still too many prescriptions being written for durations of use that are too long for the clinical purpose of the treatment -- and delivered at doses that are too high.

But at the same time, we also know that there are patients who live with significant acute and chronic pain.

For some of these patients, opioids are the only drug that’ll work effectively to alleviate that pain and help them live bearable lives. That includes many cancer patients.

We need clear, evidence-based guidelines that help us more clearly discriminate between these dual circumstances – the situations where opioids are being over used, and the conditions where these drugs are sometimes the only appropriate option for the treatment of pain. And that’s what we’re here to discuss.

There’s an effort to put in place fixed, legal limits on how many days an opioid prescription can be written for on a first fill.

Some states are adopting seven-day limits. Other states are choosing shorter durations of use.

I support the goal of curbing inappropriate prescribing. And let me be clear, I support limits on prescribing and first fills.

But I believe these policies can be even more effective if they take closer consideration of the clinical circumstance in which the opioid is being used and the evidence on proper duration.

Let me briefly relate some of these considerations.

First, the risk of developing addiction is not just a factor of the overall length of a prescription in terms of the number of days it’s written for. It’s also a function of the dose that’s prescribed.

And second, putting a fixed limit on the duration of use cuts both ways. A seven-day fill makes a lot of sense when a doctor might have otherwise opted for a 30-day supply. But what about a circumstance where the appropriate duration of use was just one or two days? Does the two-day prescription become a seven-day prescription if that’s the maximum the law permits?

This is especially true when considered against the fact that for most acute pain conditions, just one or two days of opioids are the most appropriate duration. Data clearly shows that for many common uses of opioids -- where doctors are treating acute pain such as treatment following laparoscopic appendectomy or cholecystectomy -- just one or two days of opioids are sufficient.

Sure, it’s the case that a law limiting a first fill to seven-days will reduce the number of 30-day prescriptions. That’s a very positive step forward. But for every 30-day fill that becomes seven days, it’s possible that a prescription that should have been one or two-day days will also become seven days.

What we need are science-based prescribing criteria that more closely ties duration to the clinical purpose for the prescription. I support limits on prescribing and first fills. But where possible, those limits should be tied to evidence that demonstrates the proper duration of use, so that if a given condition only requires two days of therapy, then the limit is two days and not seven.

This leads me to the topic of our discussion today.

The best way to rationalize prescribing, reduce inappropriate use, while still making sure appropriate patients have access to required analgesia is to develop evidence-based guidelines where the recommended dose and duration is closely matched to the evidence that informs the appropriate dose and duration of use. The FDA is taking many new steps to promote the development of these evidence-based guidelines.

We recently entered into collaboration with the National Academy of Medicine to create the scientific framework for developing evidence-based guidelines by indication.

We’re also working on an agreement with an academic institution to systematically review data that has been submitted to us as part of new drug applications. Our goal is to assess our own files and see if we have sufficient data on hand to develop guidelines that would govern prescribing for some common, acute pain indications. By using these available data, we may be able to develop some evidence-based guidelines.

To advance all these goals, we also worked with Congress to get clear authority to develop certain evidence-based guidelines in collaboration with stakeholders, including provider groups.

We’re pursuing all these efforts. But even as we seek to advance new guidelines that can help rationalize prescribing – while making sure that appropriately indicated patients have access to proper analgesia -- we also need to make sure that we’re applying careful criteria to the approval of new opioid drugs.

This may require the FDA to adopt new policies when it comes to the approval standard for novel opioid drugs.

Opioids are a unique class of medicines.

The Controlled Substances Act is an acknowledgment that Congress wants to treat certain kinds of drugs, including opioids differently than other classes of medicines.

In the recently enacted SUPPORT Act, Congress also instructed the FDA to think differently about opioids as a drug class.

Congress did this by enacting novel and specific authorities that enable the FDA to, among other things, require certain post-market studies to evaluate new information about the efficacy of opioids for acute or chronic pain.  We can require these studies to address our growing concerns about reduced effectiveness.   Congress also directed us to consider the risks associated with the misuse and abuse of opioids as a factor in how we make decisions about approvals and withdrawals from the market.  And with these new authorities, we intend to require certain opioids to be sold in unit dose packaging and require certain opioids to be dispensed with packaging or systems that enable the drugs to be safely disposed.

The FDA has already begun implementing these new authorities. And, even before Congress granted the FDA these new authorities, we’ve started to take a different approach to the benefit-risk evaluation of opioids.

In the post-market setting, we’ve taken strong actions where appropriate, such as requesting the withdrawal of reformulated Opana ER from the market. That case was the first time FDA requested marketing withdrawal of an opioid based a consideration of risks that were apparent only when that drug was used in an illicit manner.

In the pre-market setting, we’re now routinely seeking advisory committee input on new opioid product approvals.

We’re also re-evaluating how we consider both the individual and public health impacts of new opioids as they are reviewed for approval. To that end, I’ve asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals. This new framework would evaluate how we can consider the benefits and risks of new products when judged against available opioids drugs that are already on the market.

We’ll consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers.

As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative medical benefit and population health risks of other opioids already on the market. We should consider whether we could do more to weigh approvals against existing drugs for the treatment of pain -- to ensure that new opioid drugs are differentiated from existing drugs, in terms of their overall benefits and risks, to justify their addition to the market in the context of the current crisis.

I’m committed to considering these key questions as part of a comprehensive process that the FDA has underway to develop a formal and transparent benefit and risk framework for how the agency evaluates the safety and efficacy of opioid medicines.

Currently, in applying our statute and regulations, we generally consider each new drug approval – and each new opioid drug approval – largely on its own merits. As part of our existing review process, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug.

Under the framework, we’ll ask whether and how we’d evaluate new opioids against the benefit and risk of existing opioids.

Such a framework would take into closer consideration the overall therapeutic armamentarium as we consider new opioid product approvals. It would weigh new opioids against the benefits and risks of existing drugs for the treatment of pain.

We’d describe in guidance how we characterize the benefits and risks of opioids, and what we believe the unmet medical needs are. In this way, innovators would know where the opportunities are for developing new drugs that meet the FDA’s gold standard for safety and effectiveness, while also taking measure of the crisis of opioid addiction and abuse.

As part of the effort to consider and apply a more holistic approach to the approval of new opioid drugs, I’ll also be taking these questions -- and consideration of such a framework -- to my Opioid Policy Steering Committee to evaluate what additional steps we may take within our own authority to consider these goals and the development of such an approval standard. There could also be other places where we’d seek additional input on these efforts, as well as help from Congress.

We know that Congress and the public want our evaluation of opioids to be different than how we assess drugs in other therapeutic classes. Congress agreed with us that opioids are different in granting us specific new authorities that apply to our review of opioid drugs. I believe that there are population-based considerations when it comes to drugs that are subject to such widespread abuse and misuse that warrant us to consider each new approval within a broad public health context.

Whether or not America needs another powerful opioid is an important question that’s surfaced in past approval decisions. It’ll come up again in the future. As a public health agency, we have an obligation to address this question openly and directly.

And that leads me back to the discussion today.

Supply doesn’t create demand. Merely having more approved opioids doesn’t necessarily mean that there will be more abuse, misuse, and addiction. But having drugs that are more prone to abuse, more likable, and drugs that are more disposed to diversion could contribute to the crisis.

So, we need to evaluate all these attributes as a component of how we assess risk and benefit.

And we should consider how we assess these questions against the relative benefits and risks of drugs already on the market.

But the question isn’t just whether we have the right mix of drugs to ensure proper analgesia while limiting the potential for abuse and misuse. Addressing the addiction crisis is also a matter of having evidence-based guidelines that can govern proper prescribing practices.

Efforts like the one you’re undertaking are a key to those goals.

We’ll do our part at the FDA to advance this work as we all address the crisis of addiction. We need to reduce the rate of abuse, misuse, and new addiction; while also making sure appropriate patients have access to proper treatment.

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