“Beware of fake online pharmacies” FDA’s campaign

A national campaign aimed at making Americans more aware of the prevalence of fake online pharmacies has been launched by the FDA.

The FDA (Food and Drug Administration) warned that fraudulent online pharmacies pose a danger to patient health. The Agency says it aims to help consumers make safe purchases.

American consumers find online pharmacies attractive mainly because many are so cheap compared to retail outlets in the USA. Purchasers can sometimes save from 50% to 80% when buying from foreign websites.

Source:

http://www.medicalnewstoday.com/articles/250866.php

The FDA page:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/BeSafeRxKnowYourOnlinePharmacy/default.htm

FDA guidelines for off-label information: a nice summary by SERMO

Gives a good approach of what could be a future guideline for sollicitated information about approved products

FDA guidance on social media: a draft is not enough!

(But it is a good start!)

At last, the agency has issued a draft including social tools (see below an extract), but it is far from satisfying.

“Unfortunately, the draft guidelines finally released last week by the Food and Drug Administration won’t clear up too much of the confusion. The 15-page document (PDF)—and it’s important to emphasize that this is still only a draft—focuses  exclusively on social media discussion of off-label medication use“.

What everybody was looking for was never going to happen. If you’re waiting for divine guidance, you’re still waiting.” Indeed, one unnamed pharmaceutical marketer tells Ad Age that the guidelines are “ambiguous.” But this isn’t the FDA’s only bite at the cherry; other guidelines may come down in the future as the terrain becomes clearer.

Guidance on that subject might not be divine, but it will be crucial, says Torie Bosch in Slate.

Bosch, Torie. FDA Releases Draft Guidelines on Social Media and the Pharmaceutical Industry. Slate, Posted on January 3, 2012.
http://www.slate.com/blogs/future_tense/2012/01/03/big_pharma_and_social_media_fda_releases_draft_guidelines_.html

Leigh Householder, of IQ, is more positive: “The FDA’s perspective on what brands can and should do online is really progressive – and, it sounds a lot like some of the conversations that happened on the floor of those hearings. The challenge they’re facing, of course, is how to adequately act on it.”
http://www.whatsyourdigitaliq.com/inside-the-fdas-first-ever-social-media-guidance-is-a-really-productive-perspective/

Other comments:

• http://www.ihealthbeat.org/articles/2012/1/5/fda-issues-guidance-on-using-social-media-to-discuss-drugs-devices.aspx
• http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2012/01/fda-issues-draft-guidance-on-medical-device-appeals-processes.html
• http://www.eyeonfda.com/eye_on_fda/2012/01/draft-guidance-on-unsolicited-requests-for-off-label-information.html

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Example 8: A firm asks or otherwise encourages users to post videos about their own uses of its  product on third-party video-sharing sites (e.g., YouTube), which may result in video postings about an off-label use of its product. If the firm’s initial request for posting of videos results in any questions about off-label uses, or if any off-label video posting made in response to the firm’s encouragement of video postings results in questions about the product’s off-label use, these questions would be considered solicited requests.

Example 9: If a firm sends out packets of information to known bloggers or online consumer reviewers and encourages them to write about an off-label use of its product on third-party sites and this then provokes a discussion about that off-label use, any requests inquiring about the product’s off-label use as a result of these blogs, whether posted as comments to the third-party site or directed to the firm, would be considered solicited requests.

Example 10: If a firm announces results of a study via a microblogging service (e.g., Twitter) and suggests that an off-label use of its product is safe and effective, any comments and requests received as a result of the original message about the off-label use would be considered solicited  requests.

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf

The new look of the FDA’s website

If the FDA has announced earlier a new structure (see Phar. Executive, Dec. 2011), the agency has also released a new website on the first days of January.

Mark Senak, the Eye on FDA, has immediately compiled the good points but also a certain number of questions and concerns:

In a few words,

• The new version is very nice and neat. The most compelling feature is that the landing page is CLEAN and follows a logic.  Tabs are nicely displayed at the top to feature each area in which the FDA operates. The information is grouped and organized and the space is not crowded.
• It being new, there are a few bugs: Most of the links on the landing page don’t work, …
• About the new blog, FDA Voice: There have been only three entries since the first which was on December 23. The challenge here will be to keep it real by actually engaging on issues and explaining things in a way that invites dialog rather than “talks at” stakeholders with a point of view.  The blog is nice and clean, …
• About the Social media applications proposed by the agency to improve its communication: he says: “One important and interesting feature was also a display of links to the various social media platforms that the agency has – platforms for which it is two years late on producing a guidance for industry’s use“.
• As a conclusion Mark Senak says: “Congratulations to the FDA on taking this important step on the Internet and social media. Now if they can just take that other step …. the one we’ve all been waiting for“

Senak, Mark. FDA Launches New Look for the Website, Starts a New Blog. Eye on FDA, January the 3rd of 2012.

http://www.eyeonfda.com/eye_on_fda/2012/01/fda-launches-new-look-for-the-website-starts-a-new-blog.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+eyeonfda%2FlpWT+%28Eye+on+FDA%29

Consequences of the Lack of FDA Guidance on Social Media (Reid & Senak)

There was a year-end deadline, and much debate over how much (or how little) those new rules would change the approaches that drugmakers took. But we rang in 2011 with no guidance, and the revised deadline of March 30 also came and went with no action, and there is less and less evidence that the agency will ever act.

There are 5 major consequences of the FDA decision not to move ahead:

1. Branded promotion has been stunted. Branded promotion online exists, but it has yet to flower, for the simple reason that the risk of being accused of improper marketing far outstrips the benefit of educating doctors and patients. The lack of guidance only inflates this perception of risk and stems the flow of creative ideas.
2. Unbranded promotion has been delayed. There are some excellent examples of pharmaceutical companies doing great, creative work online that is providing clear and obvious benefit to the health care system (including some great work by our clients), but these pilot efforts could have been blooming two (or more!) years ago. Instead, fear and uncertainly slowed their trajectory. Now that industry has figured it out on their own, guidance might not have a huge impact.
3. The public health has (probably) been harmed. While pharma companies — which arguable have more expertise in certain arenas of health care than any other organization — have been shackled on social media, there continues a rising tide of pseudo-science and fearmongering online. The best way to fight lousy information is with good information. Restricting the ability of industry to join this conversation has been a net benefit to those who with an anti-science agenda.
4. Basic questions remain unanswered. No one expected comprehensive guidance, but there has always been hope that the FDA would weigh in on some specific questions, such as whether — in a character-limited environment (Twitter, AdWords, etc.) — pharma companies were required to include or link to an entire package insert. Companies have made their best guesses, but, after years of study, only the FDA knows for sure what the rules are.
5. The agency has opened itself to charges of hypocrisy. The FDA has itself become increasingly skilled with its use of social media tools, even as they refused to push out guidance. It creates an unusual and ironic playing field: the FDA has great latitude to use modern communication tools to inform the public through a variety of channels, but it has stymied the industry’s ability to follow suit.

Reid, Brian. The 5 consequences of the lack of FDA Social Media Guidance. WCG, Posted on December 8, 2011. http://blog.wcgworld.com/2011/12/the-5-consequences-of-the-lack-of-fda-social-media-guidance

MarkSenakbelieves as well that the lack of guidance has meant that social media is not being used in an area where it could do a tremendous lot of good – clinical trial support. One example for the use of social media creatively in clinical trial recruitment is with YouTube.  PharmaYouTubechannels are notoriously under-utilized and the content has largely been lackluster.  Some of the most successful channels in the past, however, have featured patients talking about living with their particular condition.  (…)Using patients to talk about their experience taking a specific treatment is risky from a regulatory perspective – they can easily broaden the indication or make a superiority claim if not heavily scripted.  A patient talking about what its like to go through a clinical trial – not so much.

Clinical Trials and Social Media – Part 1 in an Intermittent Series. Eye on Fda, Posted on December 12^th, 2011.
http://www.eyeonfda.com/eye_on_fda/2011/12/clinical-trials-and-social-media-part-1-in-an-intermittent-series.html

SM: FDA needs to be clear right now!

“In short, the lack of guidance from the FDA on social media doesn’t just affect the marketing and education by medical product manufacturers but rather, has the potential to cause harm when patients or caregivers rely on third party generated material such as a Wiki, that might be incorrect.  It’s not about marketing, it’s about public health. (…)

Also in 2009, the FDA launched a new and heightened effort at transparency and there has been some success in broadening the concept, though in this case, it has been selectively applied.  There is no good reason why we should not have greater transparency in the development of guidances, particularly in cases such as this where the product has been delayed for unknown reasons.  And as called for here in the past, the agency should streamline its process and get the support of outside experts through an advisory process that would help it anticipate and understand how the changes in communication affect the consumption of healthcare information by patients and caregivers.”

Senak, Mark. FDA needs to be clear about social media. Eye on FDA, Online,Posted on 28th of November 2011.
http://www.eyeonfda.com/eye_on_fda/2011/11/fda-needs-to-be-clear-about-social-media.html

 

 

eDTCA 2.0 for big pharma in the US

Study about DTCA practices by the 10 largest Pharma:

Pharmaceutical direct-to-consumer advertising (DTCA) is legal only in the United States and New-Zealand(…)

It is linked with inappropriate medication use, over utilization, and increased spending on expensive branded drugs, and it may endanger public health due to promotion of potentially dangerous products. (…)

With the Internet’s rapid development, users have migrated from passive information sources, using read-only “Web 1.0” technology, to interactive, dynamic, and custom-built relationships, using “Web 2.0” technologies.

Along with this digital revolution, new potential DTCA marketing opportunities haven recently emerged that include Web 2.0 social networking sites and other interactive systems (“eDTCA 2.0”), which cross geopolitical borders.

The US Food and Drug Administration (FDA) has not issued guidelines on eDTCA 2.0 marketing, nor have regulators recognized eDTCA 2.0 and its potential global spillover.

Presence is strong:

- 100% are on Facebook, have blogs and provide RSS feeds

- 80% have dedicated YouTube channels and are developing mobile applications

The point is that social media are also used by illicit drug sellers to promote online sales…

 

Liang, B.A. & Mackey, T.K. Prevalence and global health implications of social media in direct-to-consumer drug advertising. Journal of Medical Internet Research, 2011, Vol. 13, N°3, pp. e64

http://dx.doi.org/10.2196/jmir.1775

Pharma and SM: one minute it’s on,…

… the next it’s off.

“Old familiar worries” are “about adverse event and off-label discussions compounded by the delay of FDA guidelines”.

“companies that abandon Facebook will miss out on a “powerful community that is already woven into billions of lives whose voices want and need to be heard“.

Business cases:

• Sanofi’s VOICES Facebook page
• Bayer’s tweets mistakes
• Roche SM guideline
• J&J Children with diabetes community
• AstraZeneca Twitter discussion

Read more on:

Houston, Peter. Pharma and social media: time to become better friends. Pharmaceutical Executive, Digital edition, September 2011. pp.68-72
http://digital.findpharma.com/nxtbooks/advanstar/pe_201109/#/72

FDA not to plan social media guidance in 2011?!

According John Mack, the Pharmaguy, the FDA ”2011 Guidance Agenda doesn’t even include social media guidance.

I don’t think the FDA is being very transparent and is sending the industry conflicting signals.”

http://bit.ly/kl3BDE

FDA announces Delay in Social Media Guidance

According the InjuryBoard blog, FDA “has once again postponed the launch of its first draft guidance for social media. This marks the second delay announced on this project in the last four months“.

The FDA was supposed to release the guidelines in late December, but stated at the time that it would delay the release of the first draft guidance until the first quarter of 2011. That has been delayed again.

Emison, Brett. FDA Once Again Delays Guidance on Social Media. Injury Board Blog, Posted on April 05, 2011.

http://kansascity.injuryboard.com/fda-and-prescription-drugs/fda-once-again-delays-guidance-on-social-media.aspx?googleid=289696