The Hamburg Manifesto

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  • 04/04/2014

As a wise man once said, “He who tooteth not his own horn, that horn shall go untooted.

This is a valuable lesson that the FDA has learned to be true. And it couldn’t have happened at a better time. Specifically, I refer to opioids.

The FDA has taken the bit out of its mouth and taken hold of the reins of pain.

While scene-stealing members of Congress, some governors, and a gaggle of state attorneys general are trying to run roughshod over science-based regulation to great attention from the media, the FDA has been quietly doing the right thing without anybody noticing.

But when you do the right thing and don’t tell anyone about it, the assumption is that you’re not doing anything. That began to change with FDA Commissioner Hamburg’s aggressive testimony in front of the Senate HELP Committee defending the agency’s October approval of Zohydro ER.

And it continued yesterday with the agency’s approval of EVZIO™ (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. Smartly, the FDA used the approval to speak, more broadly, to the topic. There was a lot to say – and it’s about time the FDA said it.

Peggy’s complete remarks can be found here.

During the stakeholder teleconference the Commissioner laid it all on the table. It turns out that the FDA is doing a lot to mitigate opioid risk after all! Most importantly, they are doing so while understanding the need to ensure appropriate access for the tens of millions of Americans suffering from chronic pain.

She got specific:

Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:

Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids.

Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids.

Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.

Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.

Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.

Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.

Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.

And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.

I can’t say I agree with all of these things. (Upscheduling impacts appropriate access), but it’s a pretty powerful list.

And, it seems, recalling drugs that are currently on the market isn’t on the agenda.

In the immortal words of Don Draper, “If you don't like what is being said, then change the conversation.

Peggy returned again and again to the role the FDA must play in facilitating physician education, not only through labeling language but physician education. She specifically mentioned CME and working to develop (with a broad constituency) validated tools for physicians to use in determining which patients may be more prone to slide into abuse so they can choose their therapeutic recommendations more precisely.

“It all comes back to provider education,” she said. Amen.

Provider education – the Hamburg Manifesto.

That’s not regulatory mission creep; it’s the appropriate application of the agency’s Safe Use of Drugs initiative. The way you make a drug “safer” is to ensure that it is used by the right patient in the proper manner.

Importantly, the Commissioner regularly referred not to “abuse” but to “misuse and abuse.” That’s more than a rhetorical flourish since it recognizes that misuse is a gateway to abuse.

Joining Dr. Hamburg on the call were Michael Botticelli, Acting Director, Office of National Drug Control Policy, Douglas Throckmorton, M.D., Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA, Melinda Campopiano, M.D., Senior Medical Officer, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, and Wilson Compton, M.D., Deputy Director, National Institute on Drug Abuse, National Institutes of Health.

Oh, and HHS Secretary Kathleen Sebelius, who never mentioned the word “recall” either. It looks like the specter of Secretarial interference is off the table. Kudos to Secretary Sebelius for making it clear this is a cross-departmental priority.

The take away message was loud and clear –misuse and abuse of opioids is a serious issue that must be addressed in an appropriate manner.

And, per today’s teleconference, “appropriate” means science-based and patient-centric.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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