Monday, November 23, 2009

Did State Medicaid Programs Finance Plavix Direct-to-Consumer Advertising?

When the November 15, 2009, AARP Rx Watchdog Report revealed that manufacturer prices for widely used brand name drugs have climbed dramatically over the last year, despite a negative general inflation rate, many people -- including several Congressmen -- suspected “price gouging” in anticipation of future cost containment under new healthcare legislation.

But there may be another type of drug "price gouging" going on -- deliberately raising drug prices to cover the cost of Direct-to-Consumer advertising (DTCA)!

A new study published in today's issue of the Archives of Internal Medicine (“Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid”; Arch Intern Med. 2009;169[21]:1969-1974) offers evidence that drug price increases are engineered to cover the costs of DTCA.

The authors of the paper examined pharmacy data from 27 Medicaid programs from 1999 through 2005. They analyzed changes in the number of units of clopidogrel (Plavix) dispensed, cost per unit dispensed, and total pharmacy expenditures.

What’s interesting about this study is that it was able to compare volume and costs before and after DTCA initiation. Plavix has been marketed extensively using DTCA starting in 2001, several years after it was initially released. There was no DTCA for Plavix from 1999 to 2000. From 2001 to 2005, U.S. spending on DTCA for Plavix exceeded $350 million, an average of $70 million per year. “This preliminary analysis of an ideal case study,” said the authors, “allowed us to estimate changes in prescribing after the initiation of DTCA, while controlling for existing pre-DTCA trends.”

“One could surmise that DTCA might lead to increased expenditures via 3 mechanisms,” noted the authors. These are:
  1. Increased use as a result of marketing directed to patients would lead to increased total pharmacy costs.
  2. Regardless of increased use itself, pharmaceutical companies might try to offset the expense of DTCA—more than $5 billion in 2006—by increasing the price of the advertised drug.
  3. If manufacturers expect or receive an expanded indication for a particular product, they may both increase price and initiate DTCA.
According to DTC expert, Bob Ehrlich, “DTC is a tactic to improve sales not the fundamental driver of sales. For blockbuster drugs like Lipitor DTC may account for an incremental 1-2% of sales. The best DTC campaigns may provide a higher boost to sales, maybe up to 10% of the total for lifestyle drugs” (see "Business Week on DTC").

In other words, experts like Ehrlich support mechanism #1 above and contend that DTCA boosts sales volume and use of the advertised drug. Therefore, drug prices are not linked to DTCA according to these experts.

The authors of the Plavix/Medicaid study, however, did not find a spike in sales after initiation of Plavix DTCA. What they did find was a spike in unit cost, which supports mechanism #2. In essence, the drug companies that market and sell Plavix – sanofi-aventis and BMS – may have raised the price it charges Medicaid for Plavix in order to cover the costs of direct-to-consumer advertising! This is an interesting finding, especially if it can be generalized for all DTC-promoted drugs. It certainly should be of interest to the federal and state governments that pay for Medicaid drug benefits!

Here are the "smoking gun" data charts published by the authors:

 


The number of clopidogrel units per 1000 enrollees per quarter in 27 Medicaid programs from 1999 through 2005. The vertical line and the gray bar indicate the start of network news advertising in the fourth quarter of 2001. The solid lines represent the fitted interrupted time series analysis, and the dashed line represents the expected use rate based on the pre–direct-to-consumer advertising (DTCA) trend. The analysis indicated no statistically significant change in either the level (P=.18) or the trend (P=.10) after DTCA initiation. Copyright © (2009) American Medical Association. All rights reserved.



Pharmacy reimbursement per unit of clopidogrel per quarter in 27 Medicaid programs from 1999 through 2005. The vertical line and the gray bar indicate the start of network news advertising in the fourth quarter of 2001. The solid lines represent the fitted interrupted time series analysis, and the dashed line represents the expectation based on the pre–direct-to-consumer advertising (DTCA) trend. The analysis indicated a significant increase in level of $0.40 per unit after DTCA initiation (95% confidence interval, $0.31-$0.49; P<.001). It indicated no statistically significant change in the existing trend (P=.66). Copyright © (2009) American Medical Association. All rights reserved.

An interesting factoid:

The authors estimate the overall increase the 27 state Medicaid programs paid for Plavix amounted to $207 million. These 27 programs account for 67% of all Medicaid enrollment. If we expand the estimate to cover the other 33% of Medicaid enrollees, then Medicaid may have paid over $300 million in increased costs, which covers practically all of the $350 million spent on Plavix DTC during the period studied!

Sunday, November 22, 2009

FDA Intern & the Next Steps Toward Pharma Social Media Salvation!

Now that the big FDA public hearing is over, many people are asking "What's the next steps?" If you are like me, you expect FDA to issue new guidance. My friend John Murray has outlined the usual process FDA goes through when developing guidance here.

But some of us are anxious to see if stakeholders can get more involved in the process. For example, does the FDA plan to pull in any outside consultants, or hire additional experts internally, to help craft the guidelines? There are other questions as well, like Will there be an additional comment period after draft guidelines are published?


I learned that FDA Intern, strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach, is also on a quest to determine the next steps!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

Let's join FDA Intern in her latest adventure:  
FDA Intern & the Next Steps Toward Pharma Social Media Salvation!








Ask FDA Your Questions About What's Next
Everyone wants to know what happens next as the FDA deliberates what, if any, guidance it should draft regarding the regulation of Rx drug and device promotion on the Internet and social media.

We have questions like:

* Will new guidelines be drafted before the end of 2010?
* Will FDA seek help by forming a special working group?
* etc.

While the FDA may not be able to fully answer all these questions, they would appreciate receiving questions from a single source in order to expedite their replies. It certainly will help them understand the concerns.


Volunteers in concert with www.fdasm.com developed a survey/questionnaire to collect these questions in one place and forward them on to the appropriate people at the FDA.

Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.

ASK YOUR QUESTIONS HERE.

Thursday, November 19, 2009

Is Google the New FDA?

At the recent FDA public hearing, Google presented its "ideas" for standard paid search ads for Rx products. The following, for example, shows its "proposal" for "Black Box Sponsored Links:"

Click on image for enlarged view.

According to Klick Pharma's "Applying FDA Regulations to Online Marketing" guide, "Products with boxed warnings do not have the same flexibility in terms of creating reminder ads, as this form of ad is not permitted by the FDA for such drugs. While many boxed warning drugs have and continue to use branded reminder ads for search, it is not advisable given the current environment."

Bayer has chosen not to heed this warning and decided to use Google's new "proposed" format for its  YAZ search campaign, as shown in this screen shot below (the ad I am referring to is the one on top, :-):


YAZ is a special case. Not too long ago, a YAZ TV ad was cited by the FDA for violating its regulations (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?"). My criticism may have helped goose the FDA to do something it rarely does: require Bayer to run new ads to correct previous YAZ marketing. Also, Bayer entered into a settlement with several states in which it agreed to submit all YAZ ads for federal screening before they appear. The term of the agreement was 6 years.

Does this agreement include paid search ads such as the one above, or does it pertain only to TV ads? Did the FDA "screen" this YAZ sponsored Google ad? What does "screening" by the FDA mean?

Or, is the FDA irrelevant? Is Google the new FDA?

With apologies to Bob Dylan:

You've been with the Google geeks
And they've all liked your looks
With great lawyers you have
Discussed black boxes and crooks
You've been through all of
Josh Bernoff's books
You're very well read
It's well known

But something is happening here
And you don't know what it is
Do you, Mister FDA?

Tuesday, November 17, 2009

Women May Achieve 0.2 More "Satisfying Sexual Events" Per Week with BI's New "Desire Pill"!


Stop the presses! I mean literally stop press coverage of a new drug under development by the family-owned drug company Boehringer Ingelheim GmbH (BI). A glowing Bloomberg story proclaims "Boehringer’s Desire Drug Boosts Lust, Improves Sex."

I wonder if the Bloomberg reporter wrote this story with her tongue in her cheek or somewhere else. At least the BI Tweeter (@Boehringer) seemed pretty excited in this tweet sent out a few hours ago: "Great Bloomberg article on female sexual desire and recent medical research from Boehringer Ingelheim http://bit.ly/44CIt #ESSM" The #ESSM hash tag refers to the European Society for Sexual Medicine annual meeting, which is taking place in -- where else? -- Lyon, France. At that meeting, results of two clinical tests of 1,378 North American patients where presented.

And what did these results show?

According to the Bloomberg article, which probably quoted extensively from BI press releases, "Pooled results from 1,378 women in the so-called Daisy and Violet trials in North America showed that women taking 100 milligrams of flibanserin nightly reported an average of 4.5 satisfying sex acts per month, up from 2.8 acts during a four- week test period used to establish a baseline for comparison. Women taking a placebo reported 3.7 satisfying sex acts, compared to 2.7 acts during the baseline period."

So, compared to placebo, women taking BI's "desire drug," flibanserin, experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. That's about 0.2 more per week.

By the way, a "satisfying sex act" can include ... wait for it ... masturbation!

BI is desperate for new drugs "because it faces the loss of 1 billion euros ($1.5 billion) in annual revenue when two older medicines, Mirapex for Parkinson’s disease and Flomax to treat enlarged prostate, lose patent protection next year."

"The U.S. market for medicines to rekindle female desire could exceed $3.5 billion a year," said the Bloomberg article. Isn't that more than the current US sales of Viagra, Cialis, and Levitra combined? That seems like a lot of money to pay for 10 or so yearly masturbatory sexual acts in patients who take these "desire pills."

"The women taking flibanserin didn’t just have more sex, but found it more satisfying," said a researcher quoted in the article.

Boy, I wish I could see the clinical trial data. I am sure it's all very scientifically valid...NOT! I mean, how do they measure a "satisfying sexual act?" I'm pretty sure they do not hook women subjects up to some kind of gizmo as Pfizer has done to measure erections in men who take Viagra (see "Pfizer's Erection Hardness Meter").

Speaking of Viagra, I see a great Pfizer/BI co-marketing opportunity here; ie, the first combined sexual enhancement "solution" for male/female couples: Viagra and BI's "desire pill" prescribed in a single package, which may technically make it a new dosage form with one single label. That would extend the patent life of Viagra. Maybe Pfizer is thinking about purchasing BI. Hey, it could happen!

BI, of course, is hoping to get flibanserin approved for sale in the US. God help us if FDA approves this snake oil product! If you thought the Viagra ads were inappropriate, wait until you see Congress's reaction to ads showing women experiencing increased sexual libido. Whichever ad agency wins that account will have a lot of interesting issues to deal with.

Saturday, November 14, 2009

FDA Social Media Guidelines Best Done in Baby Steps


In his closing remarks at yesterday's public hearing on FDA regulation of social media, Tom Abrams, Director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), said "what we have heard is it's a different medium."

As far as I know, this is the first time that anyone at the FDA has said that. Usually, the FDA says it's "media-agnostic." In other words, its regulations apply to all media and do not have to be modified for any particular medium.

I suspect that was just a defense for why the agency has not provided any specific guidelines for use of the Internet.

In fact, the FDA HAS treated one particular medium as "different" in the past: TV.

In 1997, for example, the FDA allowed direct-to-consumer (DTC) Rx ads on TV that did not include the complete approved physician labeling (package insert) as long as “adequate provision” was made to reference a toll-free phone number, a Web site or a current issue of a magazine that contains a print ad where the full safety information could be found.

Therefore, the agency has not been completely media agnostic.

Abrams went on to say "FDA wants to give this much thought as we determine the best approach to the Internet and social media tools. FDA has much work to do in this area..." Oh, Oh! Sounds like Abrams is setting us up for a long wait before FDA issues any social media guidelines. But, he also said the FDA is "determined to do this work. It's important and we will do it."

The only question is WHEN will the FDA do this work; ie, issue guidance on the use of social media?

It all depends on how "determined" the agency is and how much it plans to do in one step.

If FDA decides to bite off more than it can chew, it will take a long time to issue any guidance and whatever it comes up with will be out of date as soon as it is published.

A much better approach would be to tackle a few issues at a time. It could, for example, issue guidance regarding space limitations imposed by certain tools such as Twitter (and other SMS, text-based apps) and services such as search engine ads. FDA could officially sanction the "one-click rule" in these cases as long as certain criteria were met, such as proposed by Google and PhRMA.

I proposed the use of a special hashtage for branded Twitter posts:
If each product was assigned a unique hashtag by the FDA and all product tweets were required to include that hashtag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation.
Just as the industry has been advised to take "baby steps" when getting involved in new media, the FDA should also take baby steps when regulating the Internet. It should -- as many suggested -- set up a task force composed of different stakeholders to advise them on which issues to tackle at any given time.

If the FDA adopts the "baby step approach" to regulating the Internet, I am hopeful that the first "step" will occur before the end of 2010.


ONE SMALL STEP FOR FDA, ONE GIANT LEAP FOR PHARMA!

Friday, November 13, 2009

FDA Social Media Hearing Day 1: My Key Takeaways

In my presentation before the FDA at yesterday's public hearing, I made some specific suggestions, including the use of an FDA-designated hash tag to be included in each branded Tweet posted by pharmaceutical companies. If each product was assigned a unique hash tag by the FDA and all product tweets were required to include that hash tag, then the FDA, consumers, and healthcare professionals could easily review all the product tweets and ensure they obey regulations regarding fair balance presentation.

After my presentation, Tom Abrams, director of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), thanked me for presenting specific solutions that the FDA could consider when it creates new guidelines for the promotion of FDA-regulated products on the Internet and social media sites.

As opposed to the first Internet FDA public hearing in 1996, this one hammered into the FDA's head how important the Internet is for health information seekers. Speaker after speaker made the point: the Internet can no longer be ignored if you are serious about protecting the public health. This time, pharmaceutical companies also made the same point.

In 1996, only visionaries could imagine how important the Internet would be in the health arena. FDA is not visionary, so the agency can be excused for not acting in 1996. This time, they have seen the light and have even used the Internet themselves to help improve public health.

I got a sense of urgency from the pharmaceutical company presenters. The industry is worried about the vast amount of user-generated health information and resources on the Internet. The industry's share of voice on the Internet -- especially the social media part of the Internet -- is rapidly be dwarfed. Drug companies worry about that and they see that they need to get into the conversation. Guidelines will help them do that.

Google suggested a new way to present Rx branded paid search ads -- you can read about that on EyeOnFDA here. I think the FDA will sanction this idea in its first-ever Internet specific guidelines.

Google presented this chart, which dramatically illustrates the effect of FDA's 14 notice of violation letters on clickthrough rates of ads that did not include the product name in the ad or the URL:

More than anything, this kind of data impresses the FDA. I am sure it shook them up yesterday.

Google, however, did not mention sidewiki. Let me repeat/paraphrase what I said in my presentation yesterday:


"Mr Googlechev, tear down this sidewiki!"

Wednesday, November 11, 2009

I'm Off to FDA Hearing: Here's What I Plan to Show (PPTs) and Tell (Transcripts)

I am scheduled to make two presentations at the November 12 - 13 FDA public hearing on the use of social media for Rx (and device) promotion:

Presentation #1: Accountability, Fulfilling Regulatory Requirements, and
Posting Corrective Information
Date: November 12, 2009
Time: 9:30 - 9:45 AM
Powerpoint Deck: http://www.virsci.com/JMack-FDASM-Slides_Part1.pdf
Transcript: http://www.virsci.com/JMack-fdaSM-Presentation1transcript.pdf


Presentation #2: Social Media and Adverse Event Reporting
Date: November 13, 2009
Time: 10:20 - 10:30 AM
Powerpoint Deck: http://www.virsci.com/JMack-FDASM-Slides_Part2.pdf
Transcript: http://www.virsci.com/JMack-fdaSM-Presentation2transcript.pdf

You can watch me and other presenters in a live webcast. Find information about that here.

Keep up with what other presenters are doing and saying at www.fdasm.com

Tuesday, November 10, 2009

FDA Panelists at the Upcoming Social Media Public Hearing

Only the following 13 FDA panel members will be able to ask questions during this week's public hearing on the use of social media by the pharmaceutical industry:
  • Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
  • Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
  • Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
  • Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
  • Kristin Davis - Deputy Director, DDMAC - CDER
  • David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
  • Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
  • Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
  • Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
  • Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
  • Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
  • Robert Temple - Director, OMP - CDER
  • Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH

This is a formidable list. Aside from Jean-Ah Kang, the only person on this list who has been featured on this blog is Robert Temple (see "Temple vs. Nissen: Blood Rematch"). As one commenter to a Pharmalot post put it: "Somehow I can't work up any empathy for Dr. Temple. His 25 years at the FDA have coincided with the deterioration of the agency.

The FDA has organized two staging areas for speakers in order to facilitate getting on and off stage:

(1) Reserved rows in the front left with assigned seats, and

(2) an "On-Deck" section on stage.
    "On-deck" speakers will led to the podium like cattle to slaughter! Sorry, I am in a dark mood. But I am doubtful that such a well-oiled machine will be conducive to dialogue. Perhaps some of the FDA panelists will make it to one of the "Tweetups" planned on Thursday evening (see www.fdasm.com). That kind of interaction would be valuable.

    Monday, November 09, 2009

    PhRMA Proposes FDA-Approved Use of Universal Safety Symbol for Branded Tweets & SE Ads

    In a telephone news briefing, PhRMA proposed an "FDA-Approved Use of Universal Safety Symbol" that could be used in branded/sponsored ad links (eg, Adwords) and Twitter posts (see image below).



    PhRMA says in its slide presentation (see here):
    • Universal safety symbol (FDA logo or other FDA-approved symbol) and universal statement would indicate that the linked page contains FDA-regulated risk information (e.g., official Prescribing Information, patient Medication Guide)
    • Throughout the Web, a universal symbol would help healthcare professionals and consumers identify official, FDA-regulated medical product Web sites. Prominence of graphic could drive clicks to comprehensive information
    • Include established name and true abbreviated indication, if Internet media do not allow for full information
    • Include affirmative statement about risks, even if abbreviated
    • Universal symbol could be used on search engines, blogs, microblogs, video
    • FDA would set conditions on use of the safety symbol by manufacturers
    “Leveraging the FDA’s logo – or a universal FDA-approved graphic symbol – in search results and throughout the Web would inform patients, at a glance, that they are visiting a legitimate site that contains comprehensive FDA-regulated benefit and risk information. Such a graphic symbol could be combined with a universal warning statement to provide an indication of risk when there is little space (e.g., a search result or tweet)," said PhRMA (see "PhRMA Statement About Accessing Online Health Information").

    Reporters had several questions about the proposal, including what kind of resources FDA would need to review material before granting use of the symbol and monitoring thereafter. Jeff Francer, Assistant General Counsel at PhRMA, mentioned user fees that PhRMA proposed for FDA review of promotions. "Unfortunately," said Francer, "congress did not appropriate the money in order for that user fee to go into effect. PhRMA will continue to support a strongly-funded FDA even if it means that user fees from our companies will have to support some of these activities."

    Francer realized that there would have to be some sort of governance structure associated with the use of this symbol, such as that provided by Trustee for privacy policies. "We haven't gotten into the operational details," said Francer. "We want to use this as a way to start the conversation and have other stakeholders respond to it."

    I asked about voluntary guidelines for use of the Internet. The answer: PhRMA will wait for FDA guidance before it issues any further self-regulatory guidelines for the Internet as it did for print & TV DTC advertising. "Once the FDA acts," said Francer, "we can then move to put those standards into effect and then we can take a look at PhRMA's voluntary standards to make sure they are adequate."

    With regard to adverse event reporting, PhRMA cited "International Conference on Harmonisation (ICH) Tripartite Guideline E2D:"
    • Sponsors “are not expected to screen external Websites for ADR information.
    • However, if [a Sponsor] becomes aware of an adverse reaction on a website that it does not manage, the [Sponsor] should review the adverse reaction and determine whether it should be reported.
    • [Sponsors] should regularly screen their Websites for potential ADR case reports.”
    Later this week PhRMA will put forward the idea that FDA and FTC should "redouble their enforcement efforts against fraudulent activities on the Internet."

    Thursday, November 05, 2009

    FDA Public Hearing: Not Deja Vu All Over Again?

    At eyeforpharma's eCommunication & Online Marketing Summit, the audience had a lot of questions about the upcoming FDA public hearing. At one point, the discussion turned to the nature of the speakers for this hearing versus the 1996 hearing. I prepared the following chart to illustrate the differences:



    FDA Public Hearing Speakers


    There are some interesting differences, including:
    • No representatives from search engines spoke at the 1996 meeting. Search wasn't a factor yet.
    • There was good representation from healthcare professional groups (18%) in 1996. I'm talking about organizations like the AMA. This time there are no physician groups presenting. There's Sermo, but I count that among the health Web sites.
    • This year there are far fewer pharmaceutical/device companies presenting than in 1996 when 21% of the speakers were from pharma.
    • This year, agencies and industry service providers dominate the speaker roster. Obviously, they have the most to gain (or lose).
    Just FYI.

    My FDA Social Media Hearing Presentations

    As you no doubt know, FDA is hosting a public hearing on pharma's use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here):
    • 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA)
    • 10:20-10:30 AM on Friday, Nov 13
    You can find my presentations here (warning: BIG pdf files):
    • Part 1, covering FDA issues 1 (Accountability) & 2 (Fulfilling Regulatory Requirements)
    • Part 2, covering FDA issues 3 (Posting Corrective Information) & 5 (Adverse Event Reporting)
    These presentations summarize most of the results to date of the ongoing survey I have been running since 20 September 2009 (find the survey here). The survey includes all 19 questions for which FDA seeks answers. There were 354 respondents as of 1 November 2009.

    Some key points I will make include:
    • Media agnostic regulations are not popular among industry experts.
    • The “One-Click Rule” is desired by the industry. However, most often it takes two clicks to reach the approved labeling (PI). Since the PI is virtually unreadable, there needs to be a better way to provide the fair balance regardless of the number of clicks!
    • There are some ideas for dealing with space limitations imposed by certain social media apps.
    • DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible.
    • Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]
    • Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should be REQUIRED to do so only for sites owned or directly sponsored by them.
    • Vast majority of “Adverse Experiences” reported on social media sites do NOT meet the requirements for AE reporting.
    • Although there are monitoring tools available, the resources required to monitor all social media sites for adverse events are not justifiable.
    • Consequently, few companies have standard operating procedures for processing adverse event information from social media sites.
    • However, pharma companies can help consumers report adverse events directly to the FDA using social media tools such as widgets placed on drug.com Web sites.
    • Some innovative ideas for fulfilling regulatory requirements to submit social media promotional materials to FDA were suggested, including:
      • Register sites with FDA for agency to monitor
      • Submit “template” (design and/or sample content) of social media site to FDA for pre-approval/approval
    • But there was no consensus opinion about satisfying regulations regarding submission of social media promotional materials.
    • Too stringent regulations will prevent companies from carrying on two-way social media conversations with consumers and HCPs. Such conversations can have a beneficial impact on public health, especially when clarifying or correcting misinformation.
    While I am in favor of some new and relaxed FDA regulations/guidelines regarding pharma's use of social media, I am also in favor of HIGHER standards, the development of which should be a collaborative effort among all stakeholders. That is, FDA regulations merely define the BASEMENT level best practices that pharma needs to adopt for effective use of social media. I believe there is a need to look beyond the FDA and start building the FIRST & UPPER FLOOR level best practices. More about that in later posts.

    Right now, all eyes are focused on the FDA. No matter what guidelines the FDA comes up with, I will continue to "out" pharmaceutical marketing worst practices on this blog.