Friday, December 19, 2014

Critique of an Ad Seen in "Modern Pharma Guidance" Magazine

The ad shown on the left is the subject of an FDA/OPDP "untitled letter" (definition), which took aim at a Sunovion professional print ad for seizure med Aptiom.

According to the FDA reviewer of the ad: “Although Aptiom may reduce seizure frequency, FDA is not aware of substantial evidence demonstrating any effectiveness of Aptiom on patients' feelings of confinement associated with seizure."

A typical letter for a typical drug ad seen in a physician-targeted publication/journal.

Imagine, if you will, a parallel world in which exists a trade publication for pharmaceutical legal/regulatory professionals. Let's call the publication Modern Pharma Guidance™. 

I envision this mag containing articles that review FDA guidance documents and the industry's response to those guidances. You know, very similar to these Pharma Marketing News articles: PhRMA Tells FDA How It Wants to Correct "Misinformation" and FDA Tweet Blocks Pharma.

What would the ads look like in Modern Pharma Guidance, assuming the ads are designed by the same agencies that design drug ads in physician journals?

Pharma: The Year 2014 in Images

These are my favorite images and posts that appeared in Pharma Marketing Blog in 2014 (see embedded slide deck below - you can also view this directly on slideshare here).

It was a very interesting year, especially since FDA finally released some long-awaited social media guidance for the pharma industry. 2014 was also notable for the proliferation of pharma mobile health apps, which is another emerging area that needs FDA guidance. FDA has said that the guidances it has issued so far do not include mobile. Finally, it was the year of high prices - for both branded and generic drugs.

See below for notes.

Thursday, December 18, 2014

Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

FDA approved Amgen's Blincyto (blinatumomab) on December 3, 2014, as a second-line treatment for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, which affects around 6,000 patients in the US.

The price tag of $178,000 per two-cycle course makes it one of the most costly drugs on the market.

This is just one of the record number of 15 "orphan" drugs approved by the FDA in 2014 (read "43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases").

FDA considers Blincyto a "breakthrough" therapy, which means preliminary clinical evidence demonstrates the drug "may have substantial improvement on at least one clinically significant endpoint over available therapy."

On FDA Voice (FDA's blog), commissioner Margaret A. Hamburg said "Consider for example, Blincyto, approved just last week to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases."

Despite the extraordinarily high price of Blincyto, payers are not likely to complain about the price as much as they complained about the price of Sovaldi. Read on to learn why I believe that is true.

Wednesday, December 17, 2014

Pfizer's "Humorous" Menopause Ad Mentions the "V" Word

Pfizer marketers have done it again! First it was an all-female Viagra ad campaign for the treatment of ED (erectile dysfunction; read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Now, it's an all-female disease-awareness ad campaign about "vaginal atrophy," which appears to be a symptom of menopause that women don't talk about - hence the name of the video featured in the campaign: "The Talk" (it's embedded at the end of this post).

Three generations of women -- a teenager, her mom, and her grandma (mom's mom) -- act out how difficult it is for women to talk about "woman problems" as my mom would say.

The mom first tries to talk to her teenage caught about "becoming a woman." "Mom! I know!," says the daughter was she slams her bedroom door. Then, the mom acts the same way when her mom tries to talk to her about menopause. But her mom comes straight to the point: "What about changes to the vagina?," she asks. Grandma then "changes the dialogue" and specifically talks about vaginal atrophy.

Changing the dialogue -- the tagline for Pfizer's website -- is what Pfizer hopes this campaign accomplishes because it has a drug to sale: ESTRING - "a local estrogen therapy used after menopause to treat moderate-to-severe menopausal changes in and around the vagina."

Will this ad be criticized as was the Viagra ad?

Tuesday, December 16, 2014

43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases

Preliminary data announced recently by the FDA shows that 2014 is shaping up to be a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorder affecting fewer than 200,000 people in the U.S. The drug approval data from 1994 through 2014 (to date) are plotted in the following chart:

NME=New Molecular Entity, BLA=Biologic License Application; Source: "CDER New Drug Review: 2014 Update"
Let's dig deeper into the numbers.

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