Co-creation in health
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E-citizens, e-patients, communities in shaping e-health, health literacy.
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Rescooped by Giuseppe Fattori from Pharma Industry Regulation
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FDA May Establish “Office of Patient Affairs” to Capture Patient Perspectives

FDA May Establish “Office of Patient Affairs” to Capture Patient Perspectives | Co-creation in health | Scoop.it

As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

 

The move to create the office would be part of the agency’s efforts to offer “a single, central entry point to the Agency for the patient community,” as well as “triage and navigation services for inbound inquiries from patient stakeholders.”

 

The office would likely host and maintain data management systems to incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities, and the office would be part of efforts to develop a scalable and forward-looking platform for communicating with patient stakeholders, particularly online.

 

Further Reading:


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Pharma Guy's curator insight, March 15, 11:55 AM

I wonder who would head up this office?

Rescooped by Giuseppe Fattori from Pharmaguy's Insights Into Drug Industry News
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FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels

FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels | Co-creation in health | Scoop.it

FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks.


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Un nouveau site à l'attention des patients : FDA Patient Network - The FDA wants you!

Un nouveau site à l'attention des patients : FDA Patient Network - The FDA wants you! | Co-creation in health | Scoop.it
The Food and Drug Administration , acting on a law signed by President Obama in 2012, has launched the third phase of an initiative to increase patient participation in the regulation of drugs and medical devices.

Via EVELYNE PIERRON, Lionel Reichardt / le Pharmageek, Fabrice Vezin, Giovanna Marsico
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EVELYNE PIERRON's curator insight, April 24, 2013 9:22 AM

La FDA vient de lancer un  nouveau site à l'attention des patients "FDA Patient Network" afin de démystifier la lourdeur administrative de gestion des produits de santé (médicaments, dispositifs médicaux).


Sur ce site, le citoyen retrouve :

- comment les médicaments, dispositifs médicaux obtiennent leur autorisation de mise le marché

- des informations sur les essais cliniques


De plus, le citoyen peut:

- interagir avec la FDA (poser des actions, participer à des actions...)

- devenir un représentant de patient

- s'inscrire à une newsletter


De nombreuses options sont à découvrir sur ce site. Peut être cela pourrait être aussi une nouvelle vision aussi de nos autorités locales.

Rescooped by Giuseppe Fattori from Pharma Industry Regulation
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Do Physicians Understand What Level of Evidence Supports FDA's "Breakthrough" Therapy Designation?

Do Physicians Understand What Level of Evidence Supports FDA's "Breakthrough" Therapy Designation? | Co-creation in health | Scoop.it

FDA uses a bevy of new drug approval designations that marketers and, in turn, journalists, can use to their advantage. In 2015, for example, 60% of of the 45 drugs approved by the FDA were designated in one or more the following categories: "Fast Track," "Breakthrough," "Priority Review," or "Accelerated Approval."

Perhaps the most advantageous designation as far as marketers are concerned is "Breakthrough". Ten (22%) of drugs approved in 2015 received the "Breakthrough" designation.

What level of evidence does the FDA require in order to label a drug a "Breakthrough" therapy? Take this short survey and then see how physicians answered the question according to a new study published in JAMA.


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The FDA Now Officially Belongs to Big Pharma

The FDA Now Officially Belongs to Big Pharma | Co-creation in health | Scoop.it

It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved today as the next FDA commissioner. Vocal opponent Bernie Sanders condemned the vote from the campaign trail. But where was Dick Durbin? Where were all the lawmakers who say they care about industry and Wall Street profiteers making money at the expense of public health?


Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute.


Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA.


In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?


Califf has gone on record that collaboration between industry and regulators is a good thing. He told NPR, “Many of us consult with the pharmaceutical industry, which I think is a very good thing. They need ideas and then the decision about what they do is really up to the person who is funding the study.” What?


He is known for defending Vioxx which is reported to have caused at least 50,000 heart attacks and events before its withdrawal. (Merck is said to have known about Vioxx’ cardio effects but marketed the blockbuster drug anyway.)


Califf was instrumental in the Duke drug trial of the blood thinner Xarelto and a cheerleader of the drug despite medical experts’ objections to its approval and 379 subsequent deaths. Xarelto's serious and foreseeable risks were back in the news this week.


Duke, where Califf directed clinical research, is still recovering from a major research fraud scandal that resulted in terminated grants, retracted papers and a "60 Minutes" special. It is the least appropriate place from which to choose an FDA commissioner.


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Pharma Guy's curator insight, February 25, 2016 7:11 AM

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3 

Pharma Guy's curator insight, March 28, 2016 8:05 AM

Regarding Duke, you might be interested in reading this: "Duke Chimes in on Off-Label Drug Promotion. Will Califf Concur?"; http://sco.lt/5mZaL3