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Scott Gottlieb, MD - The American Pain Foundation

This text contains Dr. Gottlieb's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
the American Pain Foundation

Remarks by
Scott Gottlieb, MD

Deputy Commissioner for Medical and Scientific Affairs
Food and Drug Administration


December 8, 2005


Thank you for having me here today. I am grateful for the opportunity to talk to you today about FDA’s commitment to enabling the development of effective pain medicines, and to helping make sure that new pain treatments can be safely used by patients who need them.

It is a sad fact that serious illness is attended by sorrow and pain. The test of a system of medicine should be its adequacy in the face of suffering.

Yet even in the best settings and with the best physicians it is not uncommon for suffering to occur not only during the course of disease but as a result of its treatment.

While pain and suffering are not synonymous, physical pain remains a major cause of human suffering and is the primary image formed by people when they think about it.

It also remains a major challenge to everyone involved in the medical enterprise to measure pain and suffering, and to develop objective strategies to mitigate it.

People who are suffering -- unlike liver enzymes or EKGs -- do not meet strict criteria as objects of science. They cannot ever be completely known or known about apart from the knower -- and they cannot be measured solely in the objective terms of science.

Yet science tells us that pain remains a significant and under-treated medical problem.

According to the National Institutes of Health, 100 million people in the United States suffer from chronic pain, costing about $79 billion a year in health care and lost work time.

And certain painful conditions remain endemic: 70% of those with cancer have pain, and 157 million US workdays are missed each year due to migraines.

Globally, pain takes a huge toll. The American Pain Foundation estimates that one in four patients with pain are under treated

As you know, at FDA, we have recently expressed some concerns about legislative proposals that we believe could limit access to safe and effective pain medicines by patients who need them while, while in our view, not directly addressing a serious and growing problem of illegal diversion of these medicines by a handful of criminals.

Now let me be clear on one thing: We believe that there is a serious problem today with criminals who divert legitimate pain medicines designed to treat serious medical problems for illegal purposes.

We are deeply concerned by what we see as a growing threat from the illegal diversion and abuse of these medicines.

And we intend to work aggressively with our partners at the Drug Enforcement Administration and at other sister agencies to help stamp out this growing problem and go after the criminals who illegally divert these important medicines.

But there is a twin problem among those who suffer from acute and chronic pain and who cannot get relief from today’s medicines. The number of people suffering from chronic pain is huge, exceeding that of many other chronic diseases into which we've put many more resources.

We believe that there are ways to address this problem without creating a new one – ways to crack down on criminal activity without putting at risk access to safe and effective pain medicines for people who suffer too much from chronic pain as a result of conditions like metastatic cancer and who need the benefits that new and potentially better medicines can offer.

I want to take a step back and tell you a little more about the regulation of controlled substances and the enforcement of criminal activity involving the illegal diversion of these medical products – and in particular, the FDA’s role in these activities.

As you know, the Controlled Substances Act of 1970 requires that decisions about the approval of safe and effective pain medicines should be based on science and medicine and fall under the purview of the Department of Health and Human Services.

These responsibilities are very distinct from the functions of the Department of Justice and the Drug Enforcement Administration, which have a difficult and important task of enforcing the law and making sure that drugs aren’t being illegally diverted from legitimate medical uses.

The separation of scientific and medical factors from law enforcement factors was a basic principle of the Controlled Substances Act that was established by Congress.

Our concern is that decisions to approve these products are by nature, a public health decision, not a law enforcement decision. Law enforcement does not have a public health perspective, but is oriented to uncover criminal activity.

We also need to be concerned about new steps that would delay the approval of important new medicines – delays that can cause undue suffering among patients who need the benefits of better palliative medicines right away.

The process for approving new pain medicines already has a lot of checks and many steps in it, making it among the most challenging approval pathways that any new drug must go through.

But as I said at the outset, we are very concerned about the growing problem of illegal diversion of some drugs by a small but motivated group of criminals.

And we have discussed ways to collaborate with DEA to encourage sponsors to voluntarily engage DEA early in the process to help the law enforcement agency gather the information it needs in order to do its job when new products enter the market.

We are eager to find creative was to help DEA get engaged earlier while protecting the approval process. We are trying to work earlier with DEA to – in straightforward cases – to communicate scheduling information so that there is not a long delay at the time of approval.

There is already a lot we are doing to help DEA in its enforcement role. And there is a lot that FDA does to make sure that new pain medicines are effectively and safely used by the patients who need them. FDA currently reviews and approves, in consultation with the DEA, all risk management plans for medicines that contain controlled substances.

The FDA is ensuring that labeling clearly relays conditions for safe and effective use and will consider the use of risk management programs during the drug approval process. These safety programs include elements to ensure the identification of appropriate patients, the safe and informed use of the product by both practitioners and patients, and monitoring for potential abuse problems.

The FDA has taken steps to emphasize the importance of education for physicians, pharmacists, and the public about appropriate use of opioids, and the risks of misuse or non-medical use. These risks include fatal overdose, particularly for people who experiment with these strong pain relievers.

And we are collaborating with the DEA, the ONDCP, state medical boards, and professional medical organizations to encourage more physician education and training in pain management and treatment.

In collaboration with the FDA, the DEA has also committed to stepping up investigative efforts and enforcement actions against the illegal sale and use of prescription drugs, and in particular, the illegal sale and purchase of prescription drugs over the Internet.

There are hundreds of thousands of Web sites selling prescription drugs, and they tend to disappear as quickly as they pop up.

In all of these things, we remain mindful of the public health needs, and the simply fact that too many patients suffer from pain that could be more easily remedied by appropriate and safe use of controlled narcotics.

We also need to be mindful that we don’t put additional barriers in front of one schedule or another, because the data are very clear that when physicians are presented with an obstacle in front of one schedule, they prescribe around other schedules which can also have public health consequences.

In short, at FDA, we remain committed to helping ensure timely access to safe and effective pain medicines. And our Controlled Substance staff also work collaboratively with sponsors, right from the beginning of the NDA process, to expedite the many steps involved and provide important input and guidance.

And the bottom line is this: We need to find creative and effective ways to deal with a growing problem of illegal diversion and abuse by a handful of criminals while making sure that patients who need these medicines have timely access to safe and effective new palliative care and pain drugs.

FDA views pain as a very important area of medicine and often under-treated and still not well understood and managed. The Agency is aware of the need for novel analgesic drug products and is supportive of all efforts to improve the analgesic armamentarium.

And we are currently talking about ideas and ways to improve the critical path for development of novel, safe and effective pain medicines, and to address some of the challenges that come up during the development and approval of these medicines.

The enigma of pain, which Albert Schweitzer called "the most terrible of all the lords of mankind," has yielded slowly to determined investigators and clinicians. Pain is something complex, often enigmatic and sometimes intangible that must be treated with full respect and compassion.

The mission of medicine – and to all of us involved in the medical enterprise, especially the dedicated men and women of FDA – is to promote healing where possible, to comfort always, and above all to avoid harm.

It is clear to all of us that acute and chronic pain remains a significant and under treated medical problem. And in addressing one problem – the growing illegal diversion and abuse of legitimate pain medicines -- we cannot let our efforts to stem this abuse deter us from dealing with another challenge.

These are both urgent problems, and we need to address them in ways that protect patients and also promote development of better options for patients.

We have many new opportunities for tackling these problems, and so I look forward to working with all of you on efforts to make sure we are doing everything we can to address these urgent public health challenges.