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Development of Novel Combination Therapies
February 16, 2011 (10.1056/NEJMp1101548)
www.nejm.org/doi/full/10.1056/NEJMp1101548It seems like there’s momentum to fund the FDA’s Sentinel Initiative via PDUFA. Although, according a report in the Pink Sheet, “Industry is not interested in blindly pumping user fee revenue into the project.”
Per industry suggestions, only specific Sentinel projects would be funded by user fees and an open process would be required to make the determinations,
FDA and industry also talked about possibilities of establishing a process for determining which Sentinel projects were eligible for user fees, according to minutes of a January 10 meeting.
(Ain't transparency grand?)
The proposal would limit user-fee funded Sentinel projects to those that would “emphasize safety issues that affect classes of drugs or multiple products,” according to the minutes.
Also required would be an assessment of Sentinel’s value to regulatory decision-making on safety issues and adjustments to resource needs accordingly, with the evaluations targeted for fiscal years 2015 and 2017.
The minutes indicated both sides have agreed to the proposal and will present it to the full committee for consideration.
FDA also agreed to better describe how regulatory science upgrades would be relevant to the review model and PDUFA.
Saying publicly what has to-date only been whispered privately, both sides seem to be reaching agreement that funding for the agency’s initiative on advancing regulatory science (the Advancing Regulatory Science Initiative or ARSI) is a PDUFA-worthy proposition.
Does this foreshadow new and robust agency/industry collaboration?Stand by.
"One must have a good memory to be able to keep the promises one makes."
-- Friedrich Nietzsche
Statistics, as the saying goes, are like a Speedo. What they show you is interesting, but what they conceal is essential.
Consider the recent comments by Ezra Klein in the Washington Post. Mr. Klein first asks us to all shed a tear for the health insurance industry, telling us that it’s profit margin is only 4.54%. That sounds like the same math used by Hollywood studios to explain why blockbuster movies that gross hundreds of millions actually lose money.
But Mr. Klein (in a blog post widely circulated by AHIP) is not only chief apologist for the private payer community, but is also its finger pointer-in chief. Why are healthcare costs so expensive? According to Mr. Klein the problem is caused by “new and incredibly expensive treatments.”
Per Mr. Klein the problem is … innovation ... of the pharmaceutical and medical technology varieties. In other words what we need are fewer new molecular entities (NMEs) and not too many cutting edge medical technologies. Really?
As Albert Einstein said, “Only two things are infinite, the universe and human stupidity, and I’m not sure about the former.”
This strategy of projection and finger pointing misdirection is not only wrong – it will boomerang against those making the argument. Every poll on the issue of healthcare reform makes it abundantly clear that patients and physicians are keenly aware and unhappy with those who support a short-term cost-based payer-friendly paradigm over a more holistic patient-centric health care solution.
As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted, "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost." The repercussions of choosing short-term stock prices over long-term results are pernicious to both the public purse and the public health.On Tuesday, I was pleased to participate at DIA’s “Marketing Pharmaceuticals” conference. (More on the full meeting can be found here.)
I was on a panel entitled, “Updates on Social Media: Industry/Agency Perspective.” It came after presentations by DDMACers Tom Abrams and Jean-Ah Kang – neither of which gave any reportable updates other than that the agency is working on “multiple guidances,” with the first one being announced (maybe) in “the first quarter.”
In fairness to both Tom and Jean-Ah, they really can’t say anything other than “we’re working on it.” And they were good sports when faced with frustrated questioners straining for even a teensy sliver of a prescient tea leaf.
Jean-Ah presented data showing the continued increase in DDMAC pre-review requests (both electronic and otherwise). With the very real likelihood of decreased Congressional appropriations and zero chance of DDMAC user-fees, perhaps Abrams and Company should consider hiring Watson.
The panel on which I participated was ably moderated by the Silver Fox of healthcare marketing (aka -- John Kamp of the Coalition for Healthcare Communication) and also included Mark Gaydos (Senior Director, US Regulatory Affairs Marketed Products, sanofi-aventis), Leah Palmer, (Executive Director, Regulatory Affairs Amgen), and Paul James Savidge (Vice President & Associate General Counsel Bristol-Myers Squibb).
I kicked off the panel with the following comments:
The Five Misunderstandings of Regulated Social Media
The use of social media by regulated industry is faltering because of fear, timidity and misunderstanding.
I’d like to make five main points that are often overlooked or misconstrued when we discuss social media in the context of regulated speech:
1- There is a difference between online advertising and social media
When the FDA sent out the “famous 14” warning letters on sponsored Google links, many pharmaceutical regulatory review professionals said, “See, told ya – you can’t use social media,” and breathed a secret sigh of relief – another sign of an ever-growing regulatory Stockholm Syndrome.
But they were wrong, because when you read the letters it becomes quickly evident that DDMAC equates “sponsored links” not with social media – but with paid advertising. In the context of those letters, “sponsored” equals “paid.” And there are rules for that.
Beware, because as Disraeli said, “A precedent embalms a principle.”
2- There is a difference between social media platforms and social media content
DDMAC Director Tom Abrams has made it clear that when there is guidance from the agency on social media, it will NOT include agency direction on how to use specific platforms such as YouTube or Facebook or Twitter – and that includes emerging mobile platforms too.
3- The fear of adverse event discovery is dangerous and misguided
This would not play well in a newspaper story or in front of a Congressional subcommittee.Industry’s regular and public social media “AE-phobia” only reinforces the public’s erroneous notion that industry communications are solely about money and marketing – and the public health be damned.
If industry is not afraid to mix it up in real time with real people – then it needs to walk the walk. Social media abhors a vacuum.
In 2011 we must embrace and rejoice in social media’s capability to unearth adverse experiences early and often. Quod erat demonstrandum.
4- The fear of user-generated content and off-label conversations is real … but
But these tactical solutions don’t solve or even begin to address the issue of “property owner” vs. “property user,” an issue that was mentioned by the FDA in its Federal Register notice for its November 2009 Part 15 hearing.
That’s an issue that DDMAC would be wise to address in their forthcoming guidance to industry.
5- Who’s responsible for what?
Consider the current on-the-books guidance, which reads, “Applicants should review any internet site sponsored by them for adverse experience information, but are not responsible for reviewing and internet sites that are not sponsored by them.”
But what does “sponsored” mean?
Consider the oft-heard TV voice-over, “This portion of the Masters is sponsored by (NAME OF ERECTILE DYSFUNCTION PRODUCT).
Nobody in the viewing audience thinks the sponsor chose the speed of the greens or the pairing of the golfers, or the height of the rough. But say “sponsored” on interactive social media and watch the sparks fly at internal regulatory review.
Tom Abrams has said that DDMAC guidance will address corporate responsibility for correcting and monitoring third-party sites for misinformation. It would be very useful for DDMAC to also clarify, among other things, what “sponsored” means.
Let me be blunt – expecting a regulatory Holy Grail will only lead to disappointment and frustration. And blaming the FDA when that happens won’t make anything better or move the social media agenda ahead any further or faster.
Social media is the new frontier. It is the crucial grade that exists between regulated speech and user-generated content. In the 21st century, it is where the rubber meets the road.
Social media requires interactive engagement in real time. It requires you to play rather than purchase. And that’s a wonderful opportunity – because you cannot purchase passion.
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.
