Pharma News, Social Media & Technology
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FDA and Social Media: Impact on Perscription Drug Advertising - Daily Dose MD

FDA and Social Media: Impact on Perscription Drug Advertising  - Daily Dose MD | Pharma News, Social Media & Technology | Scoop.it
Studies have shown that 60% of Americans turn to the internet for medical advice. It’s obvious how social media naturally seems like another method pharmaceutical companies can quickly and easily advertise to consumers.

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Erika Kettlewell's curator insight, December 4, 2014 3:26 AM

This is a very interesting article about how social media does not have the regulation laws that traditional advertising has in place. Living in Canada where the pharmaceutical companies are not allowed to advertise, we do not have the pushy ads on TV unless we are viewing an American channel.  What I find most note worthy is the fact that I can go onto Twitter and find any pharmaceutical company and read minimal information in a 140 characters or less. That is not giving me the proper information and also is something that needs to be taking into consideration. The majority of countries do not allow these types of ads but using social media these "posts" can be viewed from anywhere in the world. In a lot of ways it is a smart marketing tool until further laws and regulations get put into place but it does not however educate consumers fully of the benefits or potential risks of the medication.

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FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works | RAPS

FDA Explains How its New Incentive Program for Rare Pediatric Disease Treatments Works | RAPS | Pharma News, Social Media & Technology | Scoop.it
The US Food and Drug Administration (FDA) has released a long-anticipated guidance document intended to explain how a new incentive program known as the Rare Pediatric Disease Priority Review Voucher system works.
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Pfizer and Aid Groups Team Up on Depo-Provera Contraceptive for Developing World

Pfizer and Aid Groups Team Up on Depo-Provera Contraceptive for Developing World | Pharma News, Social Media & Technology | Scoop.it
Groups including the Bill and Melinda Gates Foundation aim to help bring an easier-to-inject form of Depo-Provera to 69 developing countries.
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Will Google and AbbVie's $1.5 Billion Anti-Aging Partnership Pay Off? - Motley Fool

Will Google and AbbVie's $1.5 Billion Anti-Aging Partnership Pay Off? - Motley Fool | Pharma News, Social Media & Technology | Scoop.it
Tech News
Will Google and AbbVie's $1.5 Billion Anti-Aging Partnership Pay Off?
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Smartwatches will revolutionise treatment for chronic conditions

Smartwatches will revolutionise treatment for chronic conditions | Pharma News, Social Media & Technology | Scoop.it
Google, Apple, and Samsung are racing to develop wearable technology that could be used to to monitor and track personal health and diagnose disease, explains Chris Duffey

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ChemaCepeda's curator insight, July 28, 2014 10:43 AM

¿Se convertirán estos dispositivos de cuantificación en tecnologías de acercamiento? Aún les queda mucho camino por recorrer, aunque seguro que vemos cosas interesantes

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ACRO offers new ways to keep US research competitive

ACRO offers new ways to keep US research competitive | Pharma News, Social Media & Technology | Scoop.it
The Association of Clinical Research Organizations (ACRO) offered a number of recommendations to the US House Energy and Commerce Committee’s “21st Century Cures” initiative last week as part of an effort to keep the US research industry competitive globally.
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Facebook's Human Research Program

Facebook's Human Research Program | Pharma News, Social Media & Technology | Scoop.it
If you read English and are a Facebook user, you might have been part of a research study on human behavior. In January 2012, Facebook picked out 689,003 of its users and began to manipulate the emotional content of the posts they received.
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5 Tips For Successfully Outsourcing A Medical Device Clinical Trial

5 Tips For Successfully Outsourcing A Medical Device Clinical Trial | Pharma News, Social Media & Technology | Scoop.it
Medical device manufacturers are under increased pressure to amass more clinical data on their products — from regulators, payers,...
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New Clinical Trial Search Tool Supports Online Patient Recruitment

>PRWEB.COM Newswire
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DIA 2014 50th Annual Meeting Panel to Explore Clinical Trial Enrollment Obstacles

Washington (PRWEB) May 13, 2014 Experts dedicated to enhancing clinical trials will explore hurdles in patient enrollment at the DIA 2014 50th Annual Meeting, from June 15 to 19 in San Diego. The session, 'The Patient Point-of-View: An Unrehearsed but Revealing Conversation to Rectify Patient Enrollment,' will feature the perspective of T.J. Sharpe, a prominent patient advocate who was the first to undergo a unique sequence of treatments to fight stage 4 melanoma in a clinical trial. Sharpe, who is enrolled in a second clinical trial for the drug lambrolizumab, writes the 'Patient #1' blog for http://www.philly.com.
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Industry resists FDA power grab on social media

Industry resists FDA power grab on social media | Pharma News, Social Media & Technology | Scoop.it

“Jurisdictional creep.”  “Overbroad.”  “May be unforeseen consequences.” Months before FDA's expected main venture this summer into regulating medical marketers' activities in social media, the industry reacted sharply to the agency's preliminary move—a draft guidance it issued in January on requirements for submitting interactive promotional media to regulators. 

While the response period ended in mid-April, the draft guidance continued to draw feedback, and some of the most strongly worded comments weren't posted until the last day of the month.

Comments on the draft from the Coalition for Healthcare Communication tell FDA that the question of how medical marketer influence or “control” is defined for the purposes of the submissions guidance “is perhaps the most important one to medical publishers, agencies and life science companies.” 

“In particular,” the coalition writes, “it appears the FDA is defining control to include company influence over the placement of advertising—a common practice in all advertising, including print, broadcast and online advertising.”

It points out that if FDA interprets advertiser selection of adjacent editorial content as influence or control requiring submissions to the agency, this would make “virtually all media buying an exercise in control, and thus renders all of the material on sites the responsibility of the advertiser from the point of view of FDA.” 

That would violate the traditional journalism ethic of having “a virtual Chinese wall between editorial content and advertising,” and lead to the “unforeseen consequence” of swamping FDA with “hundreds—and maybe thousands—of Form 2253 submissions that could overwhelm its capacity to review and might end up inhibiting—not facilitating—good FDA marketing review practice.”

The coalition says that some of its members also are concerned that under a broad interpretation, “collaborates on” in the guidance could mean that a firm cannot hold public relations workshops for any media that it supports with advertising or unrestricted educational grants. 

“If this were the case,” it says, “any PR department assistance in the development of a story—e.g., even connecting a New York Times reporter with the appropriate spokesperson for a particular issue or providing background information on a topic—could conceivably be covered under this provision.

“Is it the FDA's intention that if these PR activities were to occur, a company would be obligated to file a 2253 and provide a copy of the related article to the agency? We don't think so, but believe the FDA should clarify this point, because this interpretation would chill the practice of companies speaking to the media, which certainly cannot be the outcome the agency intends.” 

Slamming it as “worse than no guidance at all,” the Washington Legal Foundation (WLF) says, in comments posted April 30, that the document fails to recognize that the courts have repeatedly said that the agency is subject to First Amendment free speech protections.

WLF's comment urges FDA to withdraw Section 4 of the guidance because it is based on the premise that everything a manufacturer posts online qualifies as promotional material, falls within FDA statutory purview, and is not protected from FDA regulation by the First Amendment. 

“Agency policy in this area ought to begin with guidance regarding where FDA draws the line between speech that it is and is not permitted to regulate,” WLF says. “The draft guidance brushes aside such concerns and makes clear that FDA intends to regulate everything that a manufacturer says regarding its products on social media sites.”

This “chills manufacturer speech by requiring all such speech to be submitted for agency review, yet failing to provide manufacturers with any assurance that at least some of the submitted material is not subject to FDA regulation.” 

Manufacturer-based interests are also criticizing what they see as FDA's overbroad stretch of authority in the draft guidance.

In its comment letter, the Pharmaceutical Research and Manufacturers of America (PhRMA) highlights two fundamental concerns—an agency assumption that a biopharmaceutical manufacturer can be held accountable for content written by third parties on third-party websites if the company merely influences the third party, and an agency assumption that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. 

The Biotechnology Industry Organization (BIO) says that because of the uniqueness and rapid evolution of social media, it is important for FDA to be flexible in its regulatory approach.

As an example, it cites a healthcare professional who has a specific service arrangement with a firm (such as a paid promotional speaker). Such a person may not be acting on behalf of a firm when he or she generates content at his or her own initiation outside the scope of the contracted services. 

“In such an instance,” BIO says, “the healthcare professional is representing his or her opinion as a medical professional and engaging in medical or scientific dialogue, not within the limited scope of his or her arrangement with the firm, and thus not acting on a firm's behalf.”

Pfizer faults the draft guidance for language that “could be read as jurisdictional creep requiring submission of materials that are neither advertising nor labeling.” To lessen this risk, Pfizer supports PhRMA and BIO recommendations that the guidance be changed in favor of quarterly rather than monthly submissions to FDA. 

Also calling for more flexibility by FDA, Eli Lilly in its comments asks FDA to make clear in the final guidance that the term “interactive promotional media” necessarily means two-way communication of written text.

This would exclude, Lilly says, such one-way techniques as “links or rollover features leading to additional content, video or flash display, advertising or content that moves/scrolls with or without user assistance, and downloadable tools that allow users to provide inputs with a resulting display of information viewable only by the individual user.” 

The Medical Information Working Group, meanwhile, says the document “advances legally impermissible interpretations of FDA authority that must be corrected in the final version.” Its comment letter says the draft sets forth an ambiguous and overly broad interpretation of the agency's authority to regulate manufacturer speech and also describes manufacturer “influence and control” in a manner that is not consistent with and broader than both the governing law and earlier FDA statements.

“FDA can better respect constitutional limitations by interpreting the scope of its regulatory authority in a clear manner that is consistent with the Federal Food, Drug, and Cosmetic Act,” the coalition of medical manufacturers says.

 


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LinkedIn Gets Language Preference Targeting, Personalized Page Feeds

LinkedIn Gets Language Preference Targeting, Personalized Page Feeds | Pharma News, Social Media & Technology | Scoop.it
LinkedIn today launched two new features to help brands reach more users: language preference targeting and the personalized page feed. These new solutions

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THE *OFFICIAL ANDREASCY*'s curator insight, May 6, 2014 6:14 PM

LinkedIn goes international.

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Ampersand: Meet the PRIM&R Blog Squad for the 2014 AER Conference: Jim Gearhart

Ampersand: Meet the PRIM&R Blog Squad for the 2014 AER Conference: Jim Gearhart | Pharma News, Social Media & Technology | Scoop.it
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In-Depth: Analysis of 137 HealthKit-enabled apps

In-Depth: Analysis of 137 HealthKit-enabled apps | Pharma News, Social Media & Technology | Scoop.it

This week MobiHealthNews once again rounded up an up-to-date list of health and wellness apps that connect to Apple’s HealthKit, a health and fitness data exchange that makes it easier for iOS apps to share data with each other. For this week’s in-depth report, MobiHealthNews analyzed the ways in which these 137 health and wellness apps are integrating with HealthKit. Some only pull data from HealthKit, while others only push data into HealthKit for other apps to use. A good number — about 20 percent — do both.


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Laurent FLOURET's curator insight, November 17, 2014 12:56 PM

Looking forward to much more...: "While HealthKit makes it possible to share dozens of different types of health and fitness data, most HealthKit-enabled apps are making use of the same few data points. Active calories and weight data are both among the top three most popular data types to push or pull from HealthKit. Heart rate data and step count is right up there, too."

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A Look at Big Pharma Deals This Year - Wall Street Journal (blog)

A Look at Big Pharma Deals This Year - Wall Street Journal (blog) | Pharma News, Social Media & Technology | Scoop.it
Reuters
A Look at Big Pharma Deals This Year
Wall Street Journal (blog)
German drug maker Merck KGaA's deal to buy U.S. life sciences firm Sigma-Aldrich Corp.
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Article > Apple launches pulse-reading smartwatch

Article > Apple launches pulse-reading smartwatch | Pharma News, Social Media & Technology | Scoop.it
Apple Watch to launch early next year
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What Clinical Trials? Many Study Results Remain Under Wraps - Pharmalot - WSJ

Despite growing clamor for drug makers and researchers to publish clinical trial results, many studies are not disclosed to the public, according to a new study.
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Hospitals Are Mining Patients' Credit Card Data to Predict Who Will Get Sick

Hospitals Are Mining Patients' Credit Card Data to Predict Who Will Get Sick | Pharma News, Social Media & Technology | Scoop.it
Some hospitals troll consumer databases in an effort to identify high-risk patients
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This Day in Science 1924 - The first tuberculosis vaccine was released - StressMarq

This Day in Science 1924 - The first tuberculosis vaccine was released - StressMarq | Pharma News, Social Media & Technology | Scoop.it
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Industry shift to risk-based monitoring will change roles of CRAs, experts say

Industry shift to risk-based monitoring will change roles of CRAs, experts say | Pharma News, Social Media & Technology | Scoop.it
As CROs and sponsors look to use risk-based monitoring more for clinical trials, the role of clinical research associates (CRAs) will shift dramatically, experts said Wednesday.
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Which Social Media Platforms are Most Popular Among US Physicians?

Which Social Media Platforms are Most Popular Among US Physicians? | Pharma News, Social Media & Technology | Scoop.it
Facebook is the most commonly used social media platform by physicians up to the age of 60 years, according to "2014 Work/Life Profiles of Today's U.S. Physician" released by AMA Insurance.The surv...
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FDA, Social Media, and Health Claims | Nutritional Outlook

FDA, Social Media, and Health Claims | Nutritional Outlook | Pharma News, Social Media & Technology | Scoop.it
Social media is a powerful cog in today’s marketing machine. It’s dynamic. It’s personal. It gives consumers a voice. But as valuable as consumer-generated content is, it’s not without risk.
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National Nurses Week | Nursing Informatics | HIMSS

National Nurses Week | Nursing Informatics | HIMSS | Pharma News, Social Media & Technology | Scoop.it
Join us in this week-long celebration to raise awareness of the value of nursing and educate the public about the role nurses play in meeting the healthcare needs of Americans. (#NursesWeek begins TOMORROW!

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Pharma finds thriving in BRICs is no easy feat

Pharma finds thriving in BRICs is no easy feat | Pharma News, Social Media & Technology | Scoop.it
By Michael Fitzhugh Staff WriterDespite strong economic and logistical arguments to be made for conducting clinical trials in Brazil, Russia, India and China (the BRIC countries), increasingly compl
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