March 17th, 2011 by Felasfa Wodajo, M.D. in News
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The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information that would otherwise be available in textbooks or online.
What the FDA will consider a medical device or not has been an important topic, with many clues that it will consider its provenance broadly, as we have reported previously. As of now, only a few medical apps have been granted FDA approval, including AirStrip and MobileMIM.
According to the medical device consulting firm Emergo, the FDA said conclusively that they will be starting regulatory review of medical apps starting in 2011 at the recent FDA townhall meeting on March 10: Read more »
*This blog post was originally published at iMedicalApps*
March 11th, 2010 by Jonathan Foulds, Ph.D. in Better Health Network, News, Opinion
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In the previous posting I discussed the possibility of FDA requiring that no tobacco products be allowed to emit Carbon Monoxide. While appealing in its simplicity, such a strategy may have problems in that it could be interpreted as a ban on a whole class (or classes) of tobacco products, which the legislation does not allow.
Another strategy might be to reduce the harm from tobacco by lowering the nicotine content/delivery of cigarettes down to the level at which they are no longer addictive. A form of this strategy was proposed in the 1990’s by leading tobacco researchers Professor Neal Benowitz, and Professor Jack Henningfield. The FDA legislation singles out nicotine as the only chemical that cannot be reduced to zero, but this allows FDA the right to reduce the nicotine delivery of tobacco products down to a level just above zero at which they would no longer be addictive. Read more »
This post, Will Nicotine-Free Cigarettes Be Mandated By The FDA?, was originally published on
Healthine.com by Jonathan Foulds, Ph.D..
July 13th, 2009 by Nicholas Genes, M.D., Ph.D. in Better Health Network
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I enjoyed NYC Dr. Kent Sepkowitz’s column in Slate the other day — Paging Dr. Feelgood — where he recaps the careers of some celebrity docs and tries to imagine the pathway to enabling addicts. Key part:
In a strange way, I actually stand in awe of these guys. I have taken care of a few celebs in my career, and for me it was an awful experience. If you f*ck it up, you’re toast. Once I took care of a very important person, a person you have heard of and are very interested in, someone you would be shocked to know had the problem—asthma—that I treated him for. Well, almost treated him for. His complaints and his recollection of near death last time he had the identical symptoms so unnerved me that I asked a colleague to assume his care.
But the Dr. Feelgood experiences no such hesitancy… Perhaps it all starts innocently—a rich, famous guy with a tiny problem walks into the office. He can’t sleep at night. He’s so friendly, sincere, not stuck up like some celebs. Then he comes back a week later because of a sore ankle, wanting a little codeine and bearing an autographed photo or a CD. Other patients notice and figure you must be a pretty good doctor if Mr. Showbiz is coming in….
I once wrote about that concern over VIP complaints, in a medscape column. And, like the author, the only thing that impresses me about these celebrity docs is their creativity — Sepkowitz describes how the first Dr. Feelgood used solubilized placenta. And, while the risks of propofol dosing are drummed into our heads in training, it never occurred to me a doctor-to-the-stars might use propofol outside the hospital on an unmonitored patient.
While it didn’t surprise me that propofol has been considered in
palliative care and even implicated in a murder, it turns out propofol (diprivan) abuse and dependency is not unheard of and, as this review by Roussin shows, some IRB actually permitted trials:
Normal healthy volunteers (n = 12) were exposed in a blind fashion to acute bolus injections of 0.6 mg/kg of propofol and to a similar volume of soy-based lipid emulsion (similar to the vehicule of propofol) twice. After these sampling sessions, they were asked to choose which drug they preferred to be injected with. Propofol was chosen by 50% of the subjects, and seemed to have been based on the pleasant subjective effects. In contrast, the choice of placebo (Intralipid®) seemed to have been based on either non-intense subjective effects during the propofol sampling session (increased dizziness, confusion) or residual effects (fatigue) after the sessions. These results suggest that, in some healthy volunteers, propofol functioned as a reward.
…From a psychopharmacologists’ standpoint, propofol shares properties in common with many drugs that are abused. In particular, the onset of the effects of propofol are rapid and this drug makes people ‘feel good’ and feel relaxed [45]. The mood-altering effects of subanaesthetic doses of propofol delivered via an infusion or by an acute bolus injection have been assessed in human healthy volunteers [44,52]. Subjects reported feeling high, lightheaded, spaced out and sedated….
I read up on propofol use a lot a year ago, in preparation for a talk on procedural sedation. At that point I think its only foray into pop culture’s collective consciousness was a poem by Karl Kirchwey called “Propofol” that ran a year ago in the New Yorker. It began:
Moly, mandragora, milk of oblivion:
I said to Doctor Day, “You bring on night.”
“But then,” he said, “I bring day back again,”
and smiled; except his smile was thin and slight.
Now everyone’s talking about propofol. The ASA is using this opportunity to reintroduce talk of restricting propofol to their specialty alone (despite abundant and mounting evidence that it’s used safely in ED procedural sedation). Reporters are wondering why propofol administration is not as closely logged as, say, opiates.
All this activity suggests it soon will be. And while keeping this drug out of the hands of abusers and enablers is a worthy goal of regulation, I hope those who’ve demonstrated a safe track record are not prohibited from using this unique medication.
*This blog post was originally published at Blogborygmi*
June 22nd, 2009 by Jonathan Foulds, Ph.D. in Better Health Network, Health Policy
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On Friday 12th June, the US Senate voted in favor of a bill that gives the Food and Drug Administration the power to regulate tobacco products. President Obama (who as a Senator was a sponsor of the bill, as was John McCain) has indicated he will sign the bill into law.
Public health advocates have been fighting for FDA regulation of tobacco for over 15 years. However, not every public health advocate has supported this particular piece of legislation, and the fact that Philip Morris Tobacco Company supported it caused many to have doubts. But now that the bill is finally going to be law, what will it mean? As a guide to this, I’d recommend that you read the slides from a paper by Mitch Zeller at the recent Virginia Youth Tobacco Conference. Much of this post is adapted from his slides. These outline the key parts of the bill and what they mean in some detail and are worth a careful read, (Mitch Zeller is the former Associate Commissioner and Director of the Office of Tobacco Programs at the Food and Drug Administration). Download his slides here.
The bill does not require FDA to regulate tobacco exactly the same way it does pharmaceuticals (drugs and devices), partly because it would be impossible for any tobacco product to demonstrate that it is safe and effective for its purpose. So instead the legislation creates a new, parallel set of rules and procedures just for tobacco, but using much of the same regulatory framework that was created for drugs. The new standard around which the tobacco bill is based is THE PROTECTION OF PUBLIC HEALTH.
-Section 904 mandates that FDA will receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful
– Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products.
– FDA also has the right to request any such industry document produced prior to the enactment of this law.
– FDA can issue performance standards to prohibit or limit the allowable levels of substances in a finished tobacco product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold.
– Nicotine cannot be banned but it can be reduced to very low levels.
– FDA needs to have supporting science to back up any standards it requires, or any ingredients it wants banned.
Clearly the tobacco product standards are going to be a key part of regulation of tobacco. Here’s what the bill says on these: Read more »
This post, FDA Regulation Of Tobacco: What Does It Mean?, was originally published on
Healthine.com by Jonathan Foulds, Ph.D..
