FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe
In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (read "FDA Issues More Guidance Regarding Distribution of Reprints. Is It 'Fair and Balanced?'").The draft guidance states: "FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a...
Source: Pharma Marketing Blog - August 15, 2014 Category: Pharma Commentators Tags: FDA Guidance off-label promotion Reprints Source Type: blogs
FDA Targets Companies for Facebook 'Likes.' Is Twitter 'Favorites' Next?
(Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - August 14, 2014 Category: Pharma Commentators Tags: social media Twitter Source Type: blogs
Why I Will Be Attending Digital Pharma East
Rich Meyer initiated quite a controversy on his World of DTC Marketing blog when he posted a "guest" article by an anonymous "Senior Director for a top pharmaceutical company" who explained why he won't be attending ExL Pharma's Digital Pharma East conference this fall.Like my friend and fellow conference-goer Zoe Dunn, I have "such a pet peeve with people hiding behind an anonymous post without owning it." It's too bad that some pharma people feel the need to hide their identities when expressing their personal opinions.Meyer says there are "legal and regulatory roadblocks fr...
Source: Pharma Marketing Blog - August 12, 2014 Category: Pharma Commentators Tags: Conference Digital Pharma Source Type: blogs
#mHealthEthics: A Call for Pharma to Develop Mobile Health "Guiding Principles"
According to a "Client Alert" from Pillsbury Winthrop Shaw Pittman LLP, FDA’s new draft guidance that would exempt from premarket 510(k) review many low-risk medical devices may "smooth the path to market for many medical mobile apps that the FDA’s 2013 guidance suggested would be subject to premarket approval requirements." By "certain devices," the authors mean those that can convert a cell phone into a medical device, such as a thermometer or a stethoscope. Before the 2013 guidance was released, Bradley Merrill Thompson, General Counsel for the mHealth Regulatory Coalition, thought such...
Source: Pharma Marketing Blog - August 11, 2014 Category: Pharma Commentators Tags: Ethics Mobile mobile medical app Source Type: blogs
What Types of Health Info Do Mobile Users Seek and Is It Relevant to Advertisers?
You don't hear much about it, but pharma advertises on mobile devices. An Astellas marketing campaign for its overactive blade drug, Myrbetriq, for example, included an interstitial ad in a mobile app that drove viewers to a mobile-optimized product information Web site (listen to this Pharmaguy Audio Snippet).So, which medical conditions are most relevant for advertising by pharma on mobile devices? You might think that no matter what the platform -- PC, tablet, or mobile -- users would seek information about the same medical conditions, more or less. Thus, it's a no brainer for mobile advertisers -- just target t...
Source: Pharma Marketing Blog - August 6, 2014 Category: Pharma Commentators Tags: Astellas Mobile Mobile Advertising Myrbetriq OAB Source Type: blogs
Do PDUFA Fees Encourage Approval of Dangerous Drugs and/or Undermine FDA's Regulatory Oversight of Approved Drugs?
A new study by researchers from Cambridge Health Alliance/Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen, reveals that drugs released after the 1992 enactment of the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, were more likely to be withdrawn or have a black box warning, with 26.7 percent of these drugs receiving such a warning compared to 21.2 percent in the pre-PDUFA drugs that underwent the longer approval process (see press release here)....
Source: Pharma Marketing Blog - August 5, 2014 Category: Pharma Commentators Tags: Black Box Warning Drug Safety FDA PDUFA Public Citizen warning letters Source Type: blogs
Dr. Frances Oldham Kelsey is 100
Happy 100th birthday to Dr. Frances Oldham Kelsey, the pharmacologist whose bold stance against inadequate drug testing saved countless newborns from the perils of thalidomide, a drug which caused severe birth defects in over 10,000 infants. On her first month on the job at the U.S. Food and Drug Administration in 1960, the Canadian-born scientist resisted pressure from thalidomide's manufacturer to quickly approve the drug, which was already being widely prescribed in Europe as a painkiller for pregnant women. As a result of Dr. Kelsey's insistence on further safety testing, the drug was never approved in the US, saving a...
Source: PharmaGossip - July 25, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
The "Risk-Only" Landing Page Requirement: Can We Get FDA to Adopt FTC's Thinking and Drop This Rule?
One of FDA's Ten Commandments -- the FIRST one, in fact -- states:You shall have no other regulatory agencies before Me.Several people have asked me, "John, what other agency could pharma worship before FDA?"Glad you asked.The Federal Trade Commission (FTC) also regulates product advertising. The FDA, however, as per its first commandment, lords it over prescription (Rx) drug advertising, whereas the FTC regulates advertising of other health products, including supplements and over-the-counter (OTC) drugs. FDA, however, regulates what is claimed on the labels of OTC drugs.Whatever. The main point is that FDA ...
Source: Pharma Marketing Blog - July 23, 2014 Category: Pharma Commentators Tags: #fdasm Drug Safety FTC guidelines one-click rule regulations social media Source Type: blogs
Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access
According to the spring 2014 AccessMonitor™ report from global sales and marketing consulting firm ZS Associates, pharmaceutical access to physicians continues to decline. Only 51% of physicians/prescribers now allow access to sales reps, down from 55% in 2013 (see chart): Source: ZS AssociatesEven among traditionally pharma-friendly prescribers (e.g, dermatologists), access is down dramatically as illustrated in this chart:Source: ZS AssociatesThe decline in access continues despite the downsizing of the pharma sales force by one-third since 2008. But, the downsizing has actually helped pharma deliver better sales call...
Source: Pharma Marketing Blog - July 22, 2014 Category: Pharma Commentators Tags: Physician Marketing Sales and Sales Reps Sales Force Effectiveness Source Type: blogs
Why is PhRMA Defending Gilead's Sovaldi Pricing?
In an article published in The Hill, Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), whose job is to develop federal legislative, regulatory and political strategies, defended the pricing of Sovaldi, Gilead's Hep C drug (see "Defending Big Pharma"). Her argument was simply this: "While Sovaldi may cost $84,000 or more for an individual patient’s 12-week treatment, Reilly argues it will save money by decreasing the need for liver transplants for patients whose organs fail."Let's do the math on Sovaldi, using some numbers ...
Source: Pharma Marketing Blog - July 22, 2014 Category: Pharma Commentators Tags: Gilead HepC PhRMA Sovaldi Source Type: blogs
FDA's Ten Commandments
Remember FDA's Social Media Webinar? It was supposed to answer all our questions about the two recent social media guidances issued by the FDA.There were technical difficulties and when participants could actually gain access and hear what was being said, they were surprised that the FDA presenters were simply reading the guidance documents verbatim. "The #FDASM webinar, a haiku: Reading verbatim. Good use of my precious time? I'm not sure it is," tweeted @whendanieltalks. This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the ...
Source: Pharma Marketing Blog - July 21, 2014 Category: Pharma Commentators Tags: FDA Tom Abrams Source Type: blogs
Poetry Corner - Cancer's a funny thing
J.B.S. Haldane retained his wit even while undergoing cancer treatments — he wrote this poem in a hospital in 1964:I wish I had the voice of HomerTo sing of rectal carcinoma,Which kills a lot more chaps, in fact,Than were bumped off when Troy was sacked.Yet, thanks to modern surgeon’s skills,It can be killed before it killsUpon a scientific basisIn nineteen out of twenty cases.I noticed I was passing blood(Only a few drops, not a flood).So pausing on my homeward wayFrom Tallahassee to BombayI asked a doctor, now my friend,To peer into my hinder end,To prove or to disprove the rumourThat I had a malignant tumour.They pu...
Source: PharmaGossip - July 20, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Do Marketing Buzzwords Affect Pharma's Reputation Among Patients & Physicians?
Consultant and strategist Andrew Spong, PhD, former scholar and currently STweM‘s managing director, recently tweeted:"Building trust is far from impossible for #pharma. Abstaining from digital conferences is a great start."The tweet linked to a 2013 anti-pharma marketing screed posted on STweM titled "For pharma, the era of multi-channel marketing, closed loop marketing, sales force effectiveness, and market access is over"I assume Spong singled out "digital conferences" because these buzzwords are frequently heard at such conferences.It's a year later and the industry has "abstain...
Source: Pharma Marketing Blog - July 17, 2014 Category: Pharma Commentators Tags: Buzz/Public Relations/Image DTC Advertising Reputation social media marketing Source Type: blogs
GlaxoChinaGate contd. - now GSK admit they had previous form
GlaxoSmithKline China: Company admits to bribery scandal in 2001GlaxoSmithKline (GSK) has admitted that members of its staff were caught bribing Chinese officials back in 2001, according to the Financial Times.The new information has emerged as the pharmaceutical giant faces intense scrutiny from authorities in the UK and US regarding the alleged bribing of doctors and officials to boost drug sales to China. Police in the country have accused GSK of "ordering" the bribes.The FT report suggests that GSK was forced to fire 30 employees back in 2001 after it found staff were taking kickbacks and ...
Source: PharmaGossip - July 17, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
Total CME Revenue is Up, But Pharma Support is Down (Again) in 2013
The Accreditation Council for Continuing Medical Education (ACCME) 2013 Annual Report is out. Here's the data regarding total CME income and breakdown according to source of income. Note: the data analyzed in this post include income received by BOTH ACCME-Accredited and ACCME-recognized State-Accredited CME providers.Click on chart for enlarged view.Let's look more closely at the numbers for pharma support.Read more » (Source: Pharma Marketing Blog)
Source: Pharma Marketing Blog - July 16, 2014 Category: Pharma Commentators Tags: ACCME Source Type: blogs
