13 - 15 June 2017 | San Francisco, CA

Monday, March 20, 2017

How Many Adverse Event Reports Are Submitted to the FDA? Whatever the Answer, It's at an All-Time High!

I've been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA here. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015.

If you assume that the submission rate seen in Q1 of 2015 remained constant throughout the year, you get the following trend chart based on FDA's summary data table:

Click on image for enlarged view.
According this analysis, about 2.25 million AERs were submitted by healthcare professionals (HCPs) and consumers in 2015. An analysis by the Milwaukee Journal Sentinel and MedPage Today, however, yields drastically different numbers.

Monday, March 13, 2017

Gottlieb to Head FDA: Pharma Breathes a Sigh of Relief

DTC Advertising in the Era of High Drug Prices

TV and, to a lesser extent, print direct-to-consumer (DTC) drug ads have often been blamed for the high price of drugs. For example:

Pharma marketers are no doubt concerned that the current political atmosphere, in which both Republicans and Democrats are calling for lower drug prices, is having a negative effect on the effectiveness of their ads as consumers tune out the message (read, for example, “Pharma is Spending More on DTC Advertising But Its Effectiveness is Decreasing, Says New Survey”).

Bob Ehrlich, Chairman of DTC Perspectives, in a recent email titled "Times of Turmoil Ahead" expressed concern that DTC marketers may not adequately understand consumer sentiment viz-a-viz high drug prices:
"Most of us practicing the art and science of DTC have no control over political decisions on drug pricing and drug approval. That being said, it is imperative DTC marketers understand the popular sentiment consumers are exhibiting towards drug companies."
How does high drug prices affect the work product of DTC marketers and what does Ehrlich propose that DTC marketers do to address consumer concern regarding high drug prices?

Friday, March 03, 2017

How to Make WebMD Great Again!

World of DTC Marketing blog author and pharma marketing consultant Richard Meyer has some advice for WebMD, which may be looking for a buyer (read “’Same Amount of Eggs, More Baskets’ – Lesson Learned by WebMD re Pharma Digital Spending”).

WebMD needs pharma and medical device companies, but pharma doesn’t need WebMD,” says Meyer who has some suggestions about how to Make WebMD Great Again

“Even though WebMD is the top health portal on the web, turning traffic into revenue is hard to do as a lot of websites have found out,” says Meyer. “There are opportunities, but WebMD has to act fast.”

Here is what Meyer would do to rescue the brand:

Wednesday, March 01, 2017

Is "Right to Try" a Good Idea?

Last night, President Trump called on the FDA to speed the approval of drugs to treat life-threatening diseases, "deriding the agency’s current process as 'slow and burdensome'," according to this STATnews article.

One solution to alleviating FDA’s “slow and burdensome” approval process and getting potentially life-saving drugs to patients is "Right to Try" laws that would allow people with fatal illnesses to gain access to experimental medicines, even though they are not enrolled in a clinical trial. VP Pence and other lawmakers support this approach (see here).

“We should reform FDA so it is approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk,” said Jim O’Neill, a managing director at Mithril Capital Management, a venture capital firm run by Peter Thiel, the billionaire Trump donor and transition team advisor and candidate for FDA Commissioner (see here). “Let’s prove efficacy after they’ve been legalized.”

I decided to ask my readers if they think this is a good idea or not and to also submit comments to support their views.

So far, I've received nearly 50 responses to my survey and more than 30 interesting comments, some of which I share with you here. I invite you to take the survey and give me your opinion as well.

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