FDA

[LinksEtc]

Tweeted by @TomBurtonWSJ


Do the FDA's Regulations Governing Medical Devices Need to Be Overhauled?
Most products get to market via a fast-track process; three experts debate whether the current system makes sense

http://www.wsj.com/articles/do-the-fdas-regulations-of-medical-devices-need-to-be-overhauled-1427079649

The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it's dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps.

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Tweeted by @JohnsHopkinsSPH

"Action and Dysfunction in the U.S. Food-Safety Effort"
http://www.nytimes.com/2015/05/11/us/action-and-dysfunction-in-the-us-food-safety-effort.html?_r=2

Dr. Acheson, for one, says that nothing short of a catastrophe may be necessary to rattle officialdom sufficiently to redesign the safety system. Rather grimly, he told Retro Report, "We need — I hate to say it, but — bodies in the street before we get it."

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Tweeted by @ElaineSchattner

"An FDA panel just backed the "female Viagra." Critics say it's a mistake."
http://www.vox.com/2015/6/4/8732723/female-viagra-fda

Although the evidence hasn't improved since the FDA's last rejection of flibanserin in 2013, the marketing push around the drug has gained traction: Sprout put together the "Even the Score" campaign accusing the FDA of being sexist for not getting the pink pill on the market to help women.

the panel was convinced by the many women who had been brought there by Sprout to talk about the tragedy of their low libido

[LinksEtc]

Hmmm ... always hearing of the revolving industry/FDA door ... this is different ...


"DeWaal Leaves CSPI for FDA Post"
http://www.foodsafetynews.com/2015/06/dewaal-leaves-cspi-for-fda-post/#.VXskjX-9KSO

DeWaal, who served as CSPI's director of food safety for 21 years, will join FDA's Center for Food Safety and Applied Nutrition on Monday as the international food safety policy manager.

CSPI Executive Director Michael F. Jacobson, adding, "I know she'll continue to make significant contributions to a safer food supply in her new position."

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Tweeted by @eliza68

"Generic A.D.H.D. Drug, Not Equivalent to the Brand, Is in Use Anyway"
http://www.nytimes.com/2015/06/17/business/generic-ritalin-drug-not-equivalent-to-the-brand-is-in-use-anyway.html?smprod=nytcore-iphone&smid=nytcore-iphone-share&_r=0

The lack of action by the F.D.A., he said, has undermined his faith in generics. "We're as much in the black as the patients are.

"You're a regulator. Regulate."

[LinksEtc]

Tweeted by @drJoshS

Terrific study in @bmj_latest by @US_FDA on how company press releases do not include real reasons why drugs fail goo.gl/H6fm6y

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"Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study"

http://www.bmj.com/content/bmj/350/bmj.h2758.full.pdf

Conclusions
FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters.

[LinksEtc]

"Left in the Brain: Potentially Toxic Residue from MRI Drugs"
https://www.propublica.org/article/left-in-the-brain-potentially-toxic-residue-from-mri-drugs?utm_campaign=sprout&utm_medium=social&utm_source=twitter&utm_content=1434480864

ProPublica first disclosed in 2009 that the agency ignored two of its own medical reviewers who wanted to ban Omniscan for patients with severe kidney disease. In 2010, the FDA did act

Jacobs said the new studies "confirm that the linear gadolinium-based contrasting agents such as GE's product Omniscan and Bayer's product Magnevist are being retained at much higher levels than radiologists and the FDA have acknowledged."

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Tweeted by @hhask

"Gynecological surgery: Second rate training for second rate patients?"
http://www.philly.com/philly/blogs/healthcare/Gynecological-surgery-Second-rate-training-for-second-rate-patients.html


which refers to this article ...


"The faces of harm by a deadly failure of medical device safety legislation"
http://www.philly.com/philly/blogs/healthcare/The-faces-of-harm-by-a-deadly-failure-of-medical-device-safety-legislation.html

It comes as a shock to most Americans that the vast majority of medical devices used in hospitals across the nation do not undergo any clinical trials, safety testing or surveillance for harmful outcomes.  The Food and Drug Administration (FDA) uses a piece of legislation commonly referred to as "510(k)" to formally "clear" medical devices despite it leading to an astonishing absence of adequate safety checks.

perhaps more unacceptable is that the FDA's 510(k) clearance label on medical devices effectively also serves to sway our court system away from delivering justice - where patients have been harmed by, or died, because of faulty medical devices

[LinksEtc]

"The 100-year-old scientist who pushed the FDA to ban artificial trans fat"
http://www.washingtonpost.com/news/to-your-health/wp/2015/06/16/the-100-year-old-scientist-who-pushed-the-fda-to-ban-artificial-trans-fat/

Science won out," Kummerow, who sued the FDA in 2013 for not acting sooner

Frustrated by the lack of action, Kummerow filed a 3,000-word citizen petition with the FDA in 2009

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"Coverage of FDA's trans fat decision a high-water mark for health journalism"
http://www.healthnewsreview.org/2015/06/coverage-of-fdas-trans-fat-decision-a-high-water-mark-for-health-journalism/

sometimes the FDA and other agencies are very late to the party. As I have noted in my Antidote blog at ReportingOnHealth.org, Denmark and Argentina are among a host of countries around the world that have acted more aggressively to rid food products of trans fats, often starting with requiring that trans fats be noted on food labels and then setting a limit for trans fat content.

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"Why the FDA's new ban on trans fats may be most important change in our food supply ever"
http://www.washingtonpost.com/blogs/wonkblog/wp/2015/06/16/why-the-new-ban-on-trans-fats-may-be-most-important-change-in-our-food-supply-ever/

probably the single most important change in our food supply, if not in decades then ever," said Michael Jacobson, the executive director of the Center for Science in the Public Interest, and a longtime advocate for the change.

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http://cspinet.org/transfat/timeline.html

[LinksEtc]

Tweeted by @hmkyale

Amazing @US_FDA will not release info on #hepc drugs. What about #openscience? @YaleLawSch files complaint. Kudos. law.yale.edu/news/19674.htm...

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"MFIA Clinic Files Lawsuit Seeking Access to Clinical Trial Data for Costly Hepatitis C Drugs"
http://www.law.yale.edu/news/19674.htm#.VYwRXhWrXfU.facebook

The FDA has informed the groups that they should not expect to receive a response for 18 to 24 months and have made no guarantee that the data will even be released then

This delay will leave doctors and patients in the dark for too long

If this drug is as promising as it appears to be, what does the FDA have to hide?

[LinksEtc]

Tweeted by @bmj_latest

Debate from the latest research: what—or who—should we trust: the FDA or the journal publication? blogs.bmj.com/bmj/2015/06/12...

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"The BMJ Today: The many problems of the research enterprise"
http://blogs.bmj.com/bmj/2015/06/12/the-bmj-today-the-many-problems-of-the-research-enterprise/

Wolfe points to a little known letter written in 2013 by the US pharmaceutical trade organization. The letter documents the group's opposition to the European Medicines Agency's far reaching data disclosure policies—an interesting contrast to its public declarations that same year in favor of research transparency.

[LinksEtc]

"The FDA doesn't want to regulate wearables, and device makers want to keep it that way"
http://www.theverge.com/2015/6/24/8836049/fda-regulation-health-trackers-wearables-fitbit

The agency has already recommended letting some medical apps go to market without regulatory supervision, and the new guidance is arguably just an extension of that fact. But as the scope of medical devices has increased, device makers have asked the FDA to define exactly where the regulatory line is.

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"Media ignore impact of unsafe medical devices — unless the company CEO is a celebrity billionaire like Elizabeth Holmes"
http://www.healthnewsreview.org/2015/11/media-ignore-impact-of-unsafe-medical-devices-unless-the-company-ceo-is-a-celebrity-billionaire-like-elizabeth-holmes/

The Cures Act, you may recall, weakens already weak regulation of new medical technologies — which include the kinds of products that Holmes's company Theranos is introducing to make it easier to draw blood from squeamish patients.

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"F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs"
http://www.nytimes.com/2015/11/24/us/politics/fda-targets-inaccurate-medical-tests-citing-dangers-and-costs.html?_r=0

Inaccurate and unreliable medical tests are prompting abortions, promoting unnecessary surgeries, putting tens of thousands of people on unneeded drugs and raising medical costs, the Food and Drug Administration has concluded.

Representative Michael C. Burgess, Republican of Texas and a physician, expressed concern that the proposals "could stifle medical innovation and open the door to federal regulation of the practice of medicine."

[LinksEtc]

Tweeted by @dmalina3

What does the FDA's rejection of new sunscreen ingredients tell us about how the agency works? @drJoshS nejm.org/doi/full/10.10...

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"A Spotlight on Sunscreen Regulation"
Joshua M. Sharfstein, M.D.

http://www.nejm.org/doi/full/10.1056/NEJMp1504912

In recent months, the FDA has declined to permit use of eight new sunscreen ingredients without additional data, although those ingredients have been used in Europe for more than 5 years and despite the recent passage of a U.S. law intended to expedite the marketing-approval process for new products. The controversy says as much about the challenges facing the agency as it does about sunscreen regulation.

[LinksEtc]

Tweeted by @aaronecarroll

How Does the FDA Approve a Drug? youtu.be/WUsO6PH_O54 via @YouTube @HCTriage

https://m.youtube.com/watch?v=WUsO6PH_O54&feature=youtu.be


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Tweeted by @CMichaelGibson

"The FDA Released a Long-Awaited Social Media Policy—and It's Impressive"
http://blog.ucsusa.org/gretchen-goldman/the-fda-released-a-long-awaited-social-media-policy-and-it-is-impressive-956#.VkZ14Z0j4IQ.twitter

The FDA's new social media policy, posted online today, earns an A, or 90 out of 100 points on the scale created for the Union of Concerned Scientists' Grading Government Transparency report.

[LinksEtc]

"Tragic Patient Stories Don't Trump Weak Data, Official Says"
http://www.bloomberg.com/news/articles/2016-02-26/tragic-patient-stories-don-t-trump-weak-data-fda-official-says

The Food and Drug Administration has worked to better include patients in the development of treatments after a 2012 directive from Congress. While patient support can help a drug's chances, the key is having evidence the FDA can trust, said Janet Woodcock, director of the agency's Center for Drug Evaluation and Research. That includes randomized clinical trials where patients receiving an experimental drug are compared with others who don't -- a step some drugmakers have skipped, especially when the disease is rare or particularly deadly.

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"Lip Service To Patients And Caregivers, Or Respect? The Significance Of An FDA Panel's Review"
http://www.forbes.com/sites/elaineschattner/2016/04/25/lip-service-to-patients-and-caregivers-or-respect-the-significance-of-an-fda-panels-review/#1d0d571d6742

If patient-reported outcomes matter equally as doctor-reported outcomes, those patients' impressions should count as data, as evidence in a trial, as reasons to recommend a drug.

when it comes to drug approval and interpreting clinical information, it seems, some people turn or stay hard and cry about the e-word (emotion), as if mothers telling an FDA panel about what's happening to their kids is the opposite of science.

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Patient-Reported Outcomes
https://www.qualityforum.org/Projects/n-r/Patient-Reported_Outcomes/Patient-Reported_Outcomes.aspx

PROs have been defined as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else.

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Re: Lala's DS-- passing a peanut challenge and REDEVELOPING the allergy

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"FDA panel votes against Sarepta's drug for Duchenne muscular dystrophy"
https://www.statnews.com/pharmalot/2016/04/25/fda-panel-sarepta-muscular-dystrophy/

Beyond this one medicine, the meeting was something of a caucus on regulatory policy.

The fate of the Sarepta drug has been closely watched as a litmus test for an intensifying struggle between the FDA and patient groups that want the agency to take a more expansive view toward approving medicines for unmet medical needs.

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"Advisers to F.D.A. Vote Against Duchenne Muscular Dystrophy Drug"
http://www.nytimes.com/2016/04/26/business/muscular-dystrophy-drug-fda-sarepta-eteplirsen.html?smid=tw-share&_r=0

Anecdote and emotion do not change the data with which we are confronted, no matter the attendance

. Critics say that approving drugs that do not really work is offering false hope to patients and removing an incentive for drug companies to develop better products.

In addition, the F.D.A., in response to a 2012 law, has become more systematic in considering patient input. It has been meeting with patients with different diseases and working to evaluate drugs partly based on outcomes that patients say are meaningful to them, not just those specified by the drug company.

[LinksEtc]

"Senate confirms Robert Califf as new FDA commissioner"
https://www.washingtonpost.com/news/to-your-health/wp/2016/02/24/senate-confirms-robert-califf-as-new-fda-commissioner/

Jeffrey M. Drazen, a Harvard Medical School professor and editor of the New England Journal of Medicine, wrote in an editorial last fall that lawmakers should confirm Califf "as soon as possible."

Advocates have said the bill would help accelerate the agency's reviews and get needed innovations to patients more quickly, though some experts worry the legislation could force the FDA to compromise its high standards for safety and efficacy in the name of speed.

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"Senate confirms Robert Califf as new FDA chief, ending battle for top job"
https://www.statnews.com/2016/02/24/senate-califf-fda-confirmed/

He may get pulled into the debate over drug prices, too.

adopting a two-tier system, using limited, focused trials for medications expected to make a big impact on a small population, and very large trials using electronic heath records and social media.

The FDA is still in in the midst of implementation of the Food Safety Modernization Act, passed in 2010

[LinksEtc]

"FDA teams up with medical device industry to write 21st Century Cures Act"
http://www.healthnewsreview.org/2016/01/fda-teams-up-with-medical-device-industry-to-write-21st-century-cures-act/

the communications unearthed by Inside Health Policy and then passed on in a piece by John Tozzi of Bloomberg News ten days later add up to an uncommonly cozy relationship with much of the public being none the wiser. They should be.

The Act would allow the FDA to approve such devices not based on randomized controlled trials, the gold standard for determining safety and efficacy, but on less scientific, anecdotal evidence such as case histories.

[LinksEtc]

"Groups push pharma agenda under the guise of patient advocacy"
http://www.healthnewsreview.org/2016/02/groups-push-pharma-agenda-under-the-guise-of-patient-advocacy/

Astroturfers gather ordinary citizens from the grassroots to advocate for various causes while in reality shilling for the trade associations, PR firms, corporations, and political organizations that set them up. Now along comes a new patient advocacy organization, Patients Rising and its sister group Patients Rising Now, which debuted in late summer shortly after the House of Representatives passed the 21st Century Cures Act.

[LinksEtc]

"N-of-1 Policymaking — Tragedy, Trade-offs, and the Demise of Morcellation"
http://www.nejm.org/doi/full/10.1056/NEJMms1516161

From a policy perspective, the FDA has a mandate to keep the public safe, but medical products are associated with two types of risk: that caused by using the products and that caused by preventing their use.

The tendency to focus on eliminating an immediate harm while failing to consider potentially greater harms caused by that reaction is heightened by the power of tragic stories.

Not all anecdote-driven policies are misguided, but since we can't know in advance every consequence a regulation will have, it's worth considering how anecdote can skew risk perception

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Risk Literacy