Thursday, March 12, 2009

FDA's "Secret" Opioid REMS Meeting

Who doesn’t love to find out about secret meetings? Especially secret meetings between FDA and your top competitors?

Well, if you have any interest in FDA’s implementation of Risk Evaluation & Mitigation Strategies—especially if you market opioids—then you’re in luck. Because we’ve got the scoop on what happened at the closed-door meeting FDA held last week about requiring a class REMS for extended-release pain killers.

FDA holds closed-door sessions with industry all the time. But as we reported in “The Pink Sheet,” this meeting was especially significant: the first in a series of discussions to develop a risk management plan that will be, in the words of one FDA official, “orders of magnitide” greater than anything industry has ever seen.

For the opioids under that umbrella—and those that are not—the REMS will change the commerical landscape for prescription painkillers.

To be fair, it wasn't really a “secret” meeting: FDA announced when was taking place (March 3), and disclosed who was invited (16 opioid manufacturers, listed here). But it also wasn't open to the public, and any information about what happened at the meeting had to be gathered after it took place.

Since we published our story, FDA has released a bit more information, posting the agenda and the slide decks from the three agency presentations on its website. Division of Analgesics, Anesthetics, and Rheumatology Products Director Bob Rappaport gave a history of the risk management of the opioid class; Associate Director for Policy Jane Axelrad reviewed FDA’s REMS authorities under the Amendments Act; and deputy division director Sharon Hertz outlined FDA’s initial thoughts on the proposed REMS.

Right now, FDA wants to see a class Medication Guide; elements to assure safe use (certification of health care providers, physician training on proper use, and patient-physician agreements); and an implementation system (database of all enrolled health care providers and a system to monitor and evaluate the REMS). That could all change, of course, but that is FDA's current thinking.

None of those elements are surprising; they have all been used in past REMS. And as scheduled drugs, opioids already carry some restrictions on their use. But given the sheer size of the market involved, the development and implementation of this REMS should be watched closely.

(Image by flicker user Anna C. used with permission through a creative commons license.)


Anonymous said...

Are you kidding me. More regulation. Physicians already are issued DEA #s unless they abuse their power to prescribe pain medications.
Physicians are schooled on the actions of and can read about and understand the actions of these medications.
Physicians and their staff educate the patients on how to take the medications (all my doctors have anyway)and what to report in case of error, damage, etc.
There are ways to report any neglect or error in medication prescription/administration so what is the deal? When you report these, depending on the level of n/admin error, the people are either tutored, reskilled or have the license removed!
Are they trying to keep people from commiting suicide? If they want to kill themselves they will find a way.

Christian Sinclair said...

Thanks for the info here. I am really surprised that more people are not talking about the REMS for opioids. Even BDSI does not seem to worried about it but it seems to be there are a lot of hurdles. I plan to sign up for the FOCUS REMS program to see what it is like to go through.

I posted about Onsolis REMS at Pallimed. Would be interested if you here anything more.

Thanks again!,