FDA Social Media Guidance Controversy

FDAUnder the new FDA social media guidance, manufacturers would be responsible for monitoring their social media platforms for comments considered inaccurate, misleading or related to non approved or off label use.

They would also be liable when third party websites they have collaborated with publishes or do not filter articles, posts, ads or comments considered inaccurate, misleading or related to non approved or off label use.

All three major industry trade associations – the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed) warn FDA of significant flaws in the agency’s proposed regulations on the use of social media.

Their contention being that information and comments published online by third party comes under the first amendment and they should not have to monitor, correct or remove them even if they are misleading

The first amendment argument has been widely used to justify misleading information in non regulated industries but in the healthcare industry, misleading information, even by third party can have wide ranging consequences on the health of patients, raise false hope and create undue pressure by ill patients on doctors. Continue reading

FTC latest online ad rules

Advertisers should think twice about placing promotional messages on mobile and social media platforms like Twitter if those ads require disclosures or disclaimers to avoid being deceptive or unfair, the U.S. Federal Trade Commission said on Tuesday.

The updated guidelines for online advertising represent the commission’s attempt to catch up to more than a decade of fast-evolving new technology, from the advent of the mobile revolution to an explosion in social media like Facebook and Twitter.

This year, as in the last report issued in 2000, the FTC holds online advertisers to the same standards of honesty and full disclosure as newspapers and television.

But the limited space available on mobile platforms maintained by Twitter, Facebook and others means that it is difficult to place appropriate disclosures close enough to the ad, or prominently enough, to ensure users see it.

“Advertisers should make sure their disclosures are clear and conspicuous on all devices and platforms that consumers may use to view their ads,” the FTC’s Lesley Fair said in a blog post accompanying the 53-page report.

“That means that if an ad would be deceptive or unfair (or would otherwise violate an FTC rule) without a disclosure — but the disclosure can’t be made clearly and conspicuously on a particular device or platform — then that ad shouldn’t run on that device or platform,” Fair wrote.

And the FTC discouraged the use of pop-ups for disclosures since they are so often blocked.

“Most webpages viewable on desktop devices may also be viewable on smartphones,” the FTC said in the report. “Advertisers should design the website so that any necessary disclosures are clear and conspicuous, regardless of the device on which they are displayed.”

Twitter already requires celebrities and others who endorse products to disclose that they are being paid. Facebook had no immediate comment.

“Many of the themes about social media were already surfaced (by the FTC) a few years ago,” said Eric Goldman, Professor of Law and Director of the High Tech Law Institute at Santa Clara University School of Law.

He said the FTC’s guidelines placed the burden more on advertisers and users who take payments, than on platform companies such as Twitter or Facebook. “I don’t see anything that specifically tells Twitter, Facebook or other platforms how they have to design their platform.”

“The guidelines don’t have the force of law. but the FTC is trying to let industry know what it expects industry to do, and when the industry doesn’t do what the FTC wants, the FTC tends to get cranky.”

Original article

FDA: No Unsubstantiated Claims, Even on Social Media

No Unsubstantiated Claims on social mediaIn case some wondered, FDA guidelines apply on social media as well and liking a post from one of your followers promoting unsubstantiated claims is an endorsement of those claims.

In December 2012, the FDA sent a warning letter to Amarc Enterprises regarding two websites. This letter has garnered attention because it references Facebook. The FDA details a variety of serious concerns over the way Amarc is marketing their vitamins, in particular their websites have numerous testimonials that are unsupported by clinical data.

For example, “PolyMVA helped save my life. I began a regimen of PolyMVA… After 3 months, the Stage 2 cancer was down to Stage 1.” These vitamins have not been approved by the FDA and are being improperly marketed as drugs. Similar claims were made for pets using the products and the FDA notes that this is also a violation.

Here is what the warning letter says about Facebook: “We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims: In a March 10, 2011 post which was ‘liked’ by ‘Poly Mva’:

  • ‘PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation… Thank you AMARC’”

The product’s Facebook page has been taken down, but it appears that the claim was posted to the wall. Not only was the claim left on the wall, it was “liked” by the page administrator which would be a clear endorsement of the claim. The letter also mentions a blog post on the Amarc site that makes claims that are unsupported by scientific data.

Interestingly, their other Facebook page is still live and posting things like this: “THE BINDING OF PALLADIUM, A RARE TRACE MINERAL, WITH ALPHA LIPOIC ACID, A POWERFUL ANTIOXIDANT, DRAMATICALLY INCREASES NUTRIENT ABSORPTION AT THE CELLULAR LEVEL AND THROUGHOUT THE BODY – A BREAKTHROUGH THAT DISTINGUISHES POLY-MVA® FROM ANY OTHER SUPPLEMENT!”

I posted a link to the FDA warning letter on their wall and asked for a response. They replied, “Discussions with the FDA are ongoing and the issues raised are being addressed. AMARC is committed to our products and working with health agencies in complying with any applicable rules and regulations. This is somewhat of a normal review in the industry. Thank you for the inquiry and we will continue to support our clients and our products.”

Follow existing guidelines
It’s clear that these websites, the Facebook page and blog provided no clinical data to support any of their claims. This warning letter isn’t really about Facebook or blogs, but about following existing guidelines. The FDA is very clear on labeling and how companies can promote their products. Companies that continue to follow this guidance (on websites, Facebook and blogs) should be fine

Original article

AMA Social Media Policy

Professionalism in the Use of Social Media

The Internet and social media in particular, have created the ability for medical students and physicians to communicate and share information quickly and to reach millions of people easily. Participating in social media, social networking and other similar Internet opportunities can support physicians’ personal expression, enable individual physicians to have a professional presence online, foster collegiality and camaraderie within the profession, provide opportunity to widely disseminate public health messages and other health communication. Social media, blogs, and other forms of communication online also create new challenges to the patient-physician relationship. Physicians should weigh a number of considerations when maintaining a presence online:

(a) Physicians should be cognizant of standards of patient privacy and confidentiality that must be maintained in all environments, including online, and must refrain from posting identifiable patient information online.

(b) When using the Internet for social networking, physicians should use privacy settings to safeguard personal information and content to the extent possible, but should realize that privacy settings are not absolute and that once on the Internet, content is likely there permanently. Thus, physicians should routinely monitor their own Internet presence to ensure that the personal and professional information on their own sites and, to the extent possible, content posted about them by others, is accurate and appropriate.

(c) If they interact with patients on the Internet, physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines just, as they would in any other context.

(d) To maintain appropriate professional boundaries physicians should consider separating personal and professional content online.

(e) When physicians see content posted by colleagues that appears unprofessional they have a responsibility to bring that content to the attention of the individual, so that he or she can remove it and/or take other appropriate actions. If the behavior significantly violates professional norms and the individual does not take appropriate action to resolve the situation, the physician should report the matter to appropriate authorities.

(f) Physicians must recognize that actions online and content posted may negatively affect their reputations among patients and colleagues, may have consequences for their medical careers (particularly for physicians-in-training and medical students), and can undermine public trust in the medical profession.

Click here for source article

 

Social Media Marketers Must Provide Disclosure

Advertisers who make claims about their products on social media sites like Twitter, Facebook and Pinterest need to be mindful of the fine print they use, or forget to use, in their postings and provide disclosure.

Last week, the National Advertising Division, an investigative unit of the Advertising Self-Regulatory Council, reviewed photographs that Nutrisystem had “pinned” on Pinterest boards and determined that the photos were testimonials requiring disclosures. The photographs in question showed people who said they had lost weight by using Nutrisystem, but there was no disclosure that the people had been paid or that the results of their weight loss were not typical. Instead, the photos simply said, for example, “Christine B. lost 46 lbs on Nutrisystem.”

The self-regulatory council conducts independent reviews of marketing and advertising on all platforms, including social media. The group often responds to complaints brought by competing marketers who accuse others of violating advertising guidelines, like making unsubstantiated claims. Following a review, marketers often comply with requests to modify or settle the claim. If they refuse, the claim can be sent to the Federal Trade Commission for further review.

Andrea Levine, the director of the National Advertising Division, said the organization tends to monitor advertising in categories like health and nutrition, dietary supplements and cosmetics closely. “Those are categories where companies are not watching each other as closely and bringing their own challenges,” Ms. Levine said.

In the Nutrisystem case, the company immediately agreed to add disclosure statements to its photographs, Ms. Levine said. “As long as their stories are truthful and as long as the advertiser discloses what is the normal weight loss range, which is 1 to 2 pounds a week, that lets the consumers put the success story in context,” Ms. Levine said.

Advertising on Twitter and Facebook is also monitored closely by the investigative units in the Advertising Self-Regulatory Council. In November 2011, for example, 1-800 Contacts challenged claims made on Facebook by a competitor, Coastal Contacts.

Coastal Contacts encouraged Facebook users to “like” its page and in doing so, promised them a free pair of glasses. It also promised discounts of 70 percent on contact lenses. The rival, 1-800 Contacts, said that Coastal Contacts did not disclose the shipping and handling fees associated with the offer for free glasses and that not all styles of glasses or lenses were available in the offer.

In addition, the company contended that users who “liked” the Coastal Contacts page in order to get the free glasses were inadvertently endorsing the company.

The National Advertising Division ruled that all claims for free merchandise must clearly disclose any hidden fees and conditions at the outset of the offer, including increasing the font size of the message that “conditions apply.” Facebook likes can be interpreted as “conveying a message of general social endorsement,” the ruling said.

“If what you are offering them in exchange for likes is not real, then those likes were obtained through deceptive advertising,” Ms. Levine said of the ruling.

One of the first social media cases taken up by a related organization, the Electronic Retailing Self-Regulation Program, involved Twitter. In July 2010, the program recommended that Liquid HCG Diet discontinue using testimonials that it made on Twitter — such as, “Becky and husband lost 14 lbs in 2 days!” — and claims on Facebook that said “Lose around a pound a day” and “Lose 30 lbs in a month, it’s easy and quick!”

Twitter now offers advertisers options like promoted tweets that make it more clear to users which posts are advertisements and which are authentic content.

“It’s kind of a reminder to advertisers that even though the medium changes the rules stay the same,” Ms, Levine said.

Full article

Are you ready for the EU Cookie Directive deadline?

26th of May 2012 is the official deadline for websites to conform with the EU Cookie Directive which requires all European websites to request permission before serving cookies to EU Cookie Directivetheir visitors. Cookies are generally used to improve the  visitors’ experience by remembering what visitors are doing and displaying differently based on that information. Most tracking software also use cookies to collect data, so without cookies on your website, tracking like Google Analytics won’t work. The reason the EU Cookie Directive exists is because cookies watch the activities of visitors, so could be seen to infringe on their privacy…I can see the point but this directive is creating way more problems than it’s solving.

In order to get permission you are forced to either stop site visitors when entering your site with a pop up and demand permission at that point, OR use a banner at the top or bottom of your website asking nicely. The first option is intrusive and may well put a lot of visitors off your website altogether. The second option risks being ignored by people who just don’t understand what they’re agreeing to. What does that mean? Any tracking cookies won’t work – a missed opportunity to gather some useful data, potentially on a large chunk of your website’s visits. Also any cookies that help to make the visitor’s website experience more customised and enjoyable won’t work. Oh and not forgetting: if you’re running ads on your website that are highly targeted to the visitors, they also won’t work without getting cookie consent. If this is your website’s source of revenue, it’s a big problem!

What does the EU Cookie Directive mean to you?

You can either:

  1. Ignore it (and risk hefty fines)
  2. Stop using cookies (you’re be surprised by how much of your website actually uses cookies to run)
  3. Install the ability to request permission BEFORE using cookies on your website

How can you comply with the EU Cookie Directive?

Read more

What happens to your online profile when you’re gone?

Three Facebook users die every minute for a total of 1.78 million Facebook users in 2011, what is the future of your digital self?

You might not know what happens when you die but you can control what happens online!

You are filling the internet with status updates, image and video creating new digital dilemmas such as:

Whether you want to live forever online?
How to protect your privacy after death?
How to maintain your digital legacy?
Who to appoint as your digital executor?
Whether You Would Want to Be Digitally Resurrected

Do you know the death policies of all your online accounts?