Posted in 2009:

• Transcripts of FDA's November 2009 Public Hearing ...
• Atlas Did NOT Shrug! FDA Makes (Some) Comments Pub...
• Dear FDA: Where Are the Public Comments Regarding ...
• FDA Intern & the Next Steps Toward Pharma Social M...
• Is Google the New FDA?
• FDA Social Media Guidelines Best Done in Baby Step...
• FDA Social Media Hearing Day 1: My Key Takeaways
• I'm Off to FDA Hearing: Here's What I Plan to Show...
• FDA Panelists at the Upcoming Social Media Public ...
• PhRMA Proposes FDA-Approved Use of Universal Safe...
• FDA Public Hearing: Not Deja Vu All Over Again?
• My FDA Social Media Hearing Presentations
• Industry Groups will Eat Consumer Advocates' Lunch...
• Social Media Best Practices for Pharma Are Needed,...
• Expect FDA Social Media Draft Guidance Before End ...
• Fear and Loathing in Washington, DC
• Pharma Social Media Crips vs. Legal/Regulatory Blo...
• I Will Present Survey Results at November FDA Hear...
• Boehringer's Branded Tweet Violates FDA Regulation...
• CEI's Critique of FDA's Paid Search Stance Should ...
• Are There Special Cases for Correcting Misinformat...
• How Should Pharma Companies Submit Social Media Co...
• Should Pharma Companies Correct Drug Misinformatio...
• Is FDA's Sponsored Search Advertising Policy Incre...
• Regulatory Solutions to Overcoming Space Limitatio...
• Pharma Prefers "1-Click Rule" for Presenting Fair ...
• 3rd Party Dissemination of Altered Rx Drug Informa...
• Should FDA Regulation Depend on Specific Media or ...
• When Are Third-Party Online Discussions Not Indepe...
• What Criteria Determine Substantive Pharma Influen...
• FDA Letters Caused a Prompt, Precipitous, & Prolon...
• What Techniques are Used by Pharma to Monitor Adve...
• Who Should Be Responsible for Submitting Adverse E...
• How is Adverse Event Information from Social Media...
• Challenges Handling Adverse Events Found on SM Sit...
• Uncertainties Regarding Reporting Adverse Events F...
• Get Your FDA Social Media Public Hearing T-Shirt!
• Pharma Influence Over 3rd-Party Conversations in S...
• Let's Respond to FDA's Questions Regarding Its Reg...
• FDA Announces Public Hearing on Promotion of Drugs...
• An Example of Non-Transparency Over at FDA's Trans...
• FDA Reads My Blog: Declares Latisse Web Site Misle...
• FDA Approves Depressant Drug For The Annoyingly Ch...
• Are Organic Search Results Next on FDA's Chopping ...
• Full BOEHR(inger) Social Media Reporting of RELY T...
• Will Alli Soon Be the Only FDA-UNapproved OTC Drug...
• No FDA Regulations Would Be Like Driving on a High...
• Senator Grassley Sees Pharma Ghost Writing Problem...
• FDA Cannot Track Its Own Review of Adverse Event R...
• Unintended Consequences of FDA Warnings: Lilly-funded Antidepressant Case Study
• Pristiq DTC Campaign Challenged to Concisely Communicate Risk
• Missing FDA Letters Found. More Questions.
• Regulatory Ranters Miss the Point About FDA's Position on Search Engine Ads
• Nasonex Bee May Usher In a Whole New Way to do FDA-friendly Pharma Tweets
• Acromegaly Answers Blog Raises Interesting Regulatory Question
• End All Pharma Freebies to Physicians by Decree or Just Leave it at Caveat Doctor?
• Distribution of Reprints: Another Example of FDA Flexing Its Enforcement Muscles
• Towards a Rational FDA Policy Addressing the Internet and Social Media
• FDA Rules are NOT Media Agnostic
• Arnold Friede Blasts FDA's Right to Define "Reasonable Man" Without External Input
• Uh, Oh! Will FDA Cite this "One-Click Rule" Twitter Post by AZ as Violative?
• Communicating Risk in Online Drug Ads: Reading the Tea Leaves in Recent FDA Draft Guidance
• Dear GSK: Precedent Should Not Guide Pharma's New Media Communications Strategy
• If Off-label Use of Anti Swine Flu Drugs are OK, Why Aren't Reminder Ads that Lack Fair Balance Also OK?
• What Good Can Come from a Public FDA Hearing on Social Media?
• Want to See Adverse Events of Drugs You are Taking? Try This Site
• FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing
• New FDA Data: Adverse Event Reporting Increases Dramatically
• Twitter Lobbying Effort Calls Upon FDA to Convene a Public Hearing
• St. Google Slays the FDA Dragon?
• The Next FDA Concern May be the Use of "Redirect" URLs
• PhRMA Says FDA Should Initiate a Public Process Rather than Regulate by Warning Letter When it Comes to the Internet
• The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!
• FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!
• FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!
• FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media!
• Faux Social Marketing: Have Your Cake and Eat It Too!
• Did I Miss the Fair Balance in Last Night's Omnaris Nasal Spray TV Commercial?
• Wolfe Defanged at FDA Advisory Committee Meeting on J&J's rivaroxaban
• FDA Lacks Credibility, Says Judge in Ruling to Allow Access to Plan B by 17-year-old Women
• Pharma Dreams of Dipping Its Toe Into Social Networking Waters
• FDA's Answer to ePharma Marketing Guidelines: "circles and arrows and a paragraph on the back"
• FDA Widgets: How About One for Adverse Event Reporting?
• Tit-for-Tat Tithe on Pharma Marketing. How It Can Work.
• FDA's Answer to ePharma Marketing Guidelines: "circles and arrows and a paragraph on the back"
• Viagra Print Ad Art Imitates Life as it Could be Without FDA Regulations
• Drug Fact Box: It All Depends on What You Mean by "Fact"
• New "New Media" Trick for Pharma Marketers
• An Avodart Print Ad that FDA Missed
• FDA Warns GSK About Enlarged Avodart Ad Imagery
• Ethical Pharma Marketing
• Amgen's Bike Jersey Tchotchke Available
• Are FDA Penalties No Longer a "Slap on the Wrist?"
• YAZ Commercial Yanked from TV, But Not from YouTube
• "FDA a Failed Agency" says Dr. Steven Nissen, Contender for FDA Commissioner
• FDA's New "Good Reprint" Guidance: Off-Label Promotion to Docs is Now Virtually Unregulated

Posted in 2008:

• Eschenbach Announces Resignation, FDA Staffer Throws Shoes in "Farewell Kiss"
• Revised DTC Guidelines Do Little to Appease Legislators
• New PhRMA DTC Guidelines Ignore Elephant in Room: Moratorium
• Death of the One-Click "Rule" or "Received Precedent" or Whatever!
• Despite FDA Warning Letter, YAZ Web Site Still Connects YAZ with Treatment of Acne!
• Meet the Person Likely to be the Next FDA Commissioner
• FDA Critics Lead the Pack of Contenders for New FDA Commissioner According to Poll!
• New Disease Facing Drug Industry: Election Anxiety Disorder (EAD). Is It Justified?
• Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway
• FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?
• Vyvanse Warning Letter: Too Late! Shire Got Rid of Ty Pennington Long Ago!
• ACCME to Pharma Ad Copywriters: No Double Dipping! Stay Out of Industry-Sponsored CME.
• FDA Intern Learns All About the "Affect Misattribution Procedure"
• What's Next: Ban Free Drug Samples?
• Will Viagra be Approved for Antidepressant-Related Sexual Dysfunction in Women?
• Can a Moratorium-delayed DTC Ad Refer to a Drug as "New"?
• FDA Intern Gets Her Bonus!
• FDA Intern vs. Inebriated Advisory Committee Antagonist
• FDA DTC Review: The House that Troy Built
• Ruth Day and the Bees Repeat Performance at House DTC Hearing
• Pharma's New Marketing Partner: Medical Journals
• FTC, Generics, and the War in Iraq
• FDA DTC Payola Out, You Pay In!
• FDA Won't be Previewing TV DTC Ads!
• Did Pfizer Run a Chantix "Bookend" Ad During 60 Minutes?

Posted in 2007:

• Mevacor - STRIKE THREE! Yer Outta Here!
• The "One-Click Rule": Rant or No Rant?
• What the US FDA Could Learn from China's FDA
• Regulating DTC for BTC
• FDA Considers Color Code for Food Labels, But Not for Drug Labels
• FDA at a Mall Near You: The Manchurian Connection
• Rozerem's Cheapskate Sweepstakes Violates Children's Online Privacy Protection Act
• State Sponsored Pharma Ads: It Could Happen!
• FDA's Chang and Eng: Benefit vs. Risk
• FDA: Zimulti Non-Acomplia!
• Temple vs. Nissen: Blood Rematch
• von Eschenbach & Gonzales: Two Birds in the Same Bush
• FDA Advisor Rule Loophole?
• Drug Safety - A Mere Asterisk to the FDA
• PDUFA Payola!
• Introducing...the All-Pharma Lobbying Lineup!
• If FDA were as Powerful as FTC

Posted in 2006:

For access to the following posts, please use the Monthly Archive.

• The Next Blockbuster - You Decide!
• Where's DDMAC's Head At?
• Celebrex Joins the bAdWord Bandwagon!
• Off-Label Confusion
• Lame-Duck Senate Roasts Eschenbach Turkey!
• Pay Per DTC Ad View Update
• Wooing Dems: Thank You Mr. Kindler!
• What's In Store from Congress?
• The "Girl from Google"
• Clear Words, Obscure Benefits
• Lunesta, Google, and "bAdWords"
• Rozerem Sleeper Cell at Pri-Med Conference
• Apres IOM, le Deluge!
• IOM Report Calls for DTC Moratorium
• Pay-(FDA)-Per-(Pre)View of DTC
• WLF: A No-Risk Ad is a Good Ad
• Accountability: Imported vs. Domestic
• Fear & Loathing in Bethesda
• FDA Paralyzed: Who Will Protect Us?
• FDA Gets a "C" from the Public
• Licensing Sales Reps: Is It a Bad Idea?
• Celsius 3014: Ketek, Drug Safety, & Bioterrorism
• Spinning Bad News about FDA & Drug Safety
• FDA Coming to a Mall Near You?
• Merck Misled FDA According to NJ Jury
• FDA Backs Down on Coupon Study
• Off-label Marketing: Next State Issue
• FDA, Coupons, and Sleep Aid DTC Ads
• Gifts That Keep on Giving

For access to the following posts, please use the Monthly Archive.

• AstraZeneca's Risky Proposition
• Plan B FDAgate
• FDA DTC Hearings Day 2

• FDA DTC Hearings: Snippets from Day 1
• DTC Regulation: Trick or Treat?
• New Assault on Pharma Marketing?
• FDA May Follow PhRMA's Lead on DTC
• Ethical Pharma Marketing: Oxymoronic?

• Bloggers Worry Pharma More Than FDA
• HELP WANTED: Director of Drug Safety
• PhRMA Finalizes DTC Principles
• Restrict DTC, but Extend the Patent for New Drugs
• To Ban or Not to Ban DTC, That is the Question

• WLF Watches FDA Watching Drug Ads
• New DTC Principles Emerging
• How the FDA Can Fix DTC
• Proposal for a Drug Risk Advisory System
• FDA Drug Watch Site Guidelines

• Separation of Church and State
• "Bioshield" Boondoggle
• FDA Advisory Panels: Elephants in the Room
• Does the FDA Need to be Overhauled?
• Buzz is NOT regulated by FDA