FDA provides draft guidance on REMS
While I’m waiting for the ISGIO meeting to start in Philadelphia, I just noticed that the FDA announced draft guidelines for REMS programs see the link here : http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
I’ll add a clickable link later as this is being posted quickly from my iPhone. The important thing is that these guidelines are being announced several years after they have been running, so I think we can reasonbly assume the same thing will happen with social media guidelines.
The upcoming open town hall meeting to gather public opinion is therefore likely to be just that, information gathering. Guidelines will follow in a couple of years after some reflection and negotiations internally.
What do you think?
3 Responses to “FDA provides draft guidance on REMS”
I forgot to add that Philadelphia has turned their fountain pink on honour of breast cancer month. Nice touch!
I think you’re right Sally. It always takes some time to get guidances out for FDA. The REMS took effect in late 2007 with FDAAA,but the federal law itself had fairly detailed and specific requirements for REMS. Further, there was an analagous precedent for REMS in what FDA previously oversaw as RiskMAPs, and FDA borrowed liberally from what they had already been doing with RiskMAPs and fit it into the what FDAAA prescribed about REMS in the federal law itself.
I’m as skeptical as they come, but under the new administration, FDA seems to have a much more activist approach to regulation. They announced yesterday that in their Strategic Plan for Risk Communication that they will modernize certain aspects of fda’s promotional regulations. This is something that is long overdue. These regs were written in the 60s. Administratively, updating a regulation and passing a new rule is far more difficult than issuing a guidance (you need to go through cumbersome rule making procedures or hope for an act of congress-more likely), but FDA seems to have new-found “initiative” with the new administration with a “yes we can” approach.
Don’t expect policy making at the upcoming public meeting, but maybe we can be a little more optimistic that FDA won’t take a “business as usual” approach where these issues die a slow death of attrition and apathy. Or they take years and years and years to get out like FDA’s recent guidance on Risk Communication.
Anyway, good post and good thinking.
John Murray
Yes, that’s how public administration usually works. But in this case I’m not so sure or at least I expect that it won’t take that long.
A couple of years is a quite long time from the Internet and new technologies perspective. Things are moving at a quite fast pace. Two years ago very few people were involved with social media. Twitter was still in its first steps and was almost unknown. Let us think for a moment how the digital media landscape has changed during the past two years. And to top it all Google has just released SideWiki.
Undoubtedly all these present and future innovations will make gaps and grey areas to grow fast and will push hard on regulators to come up with an updated legal framework in accordance with the evolving new paradigm.
Miguel
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