FDA's Hot August

August has been sizzling on the East Coast, but perhaps it was most uncomfortable in the air-conditioned confines of FDA’s offices. The agency’s boil came with an early peak high and showed little sign of letting up by mid month.

Casey McDonald

Let’s start with Friday the 7th, a sad and momentous day that saw a death, a decision, and a diva chastised. Though purely coincidental, the timing of Frances O. Kelsey’s death falling on the same day as a federal court’s decision for Amarin v. FDA was seen by some as both a symbolic and literal dawning of a new era.

Kelsey, known for getting it right on thalidomide in the early 1960s
when FDA was in its infancy, saw the agency grow on the import of this regulatory intervention into the organization we know today.

Her death, at the age of 101, came amazingly on the same day that a federal district judge gave a severe blow to the FDA’s insistence on controlling truthful and non-misleading marketing.

As Jill Wechsler details in this issue’s Washington Report, the importance of this decision will be seen in years to come. But the decision was a clear statement rejecting the argument FDA has been making for decades. To further quote John Kamp, from the Coalition for Healthcare Communication, the decision “will enable marketing beyond the label that is both true and not misleading. The exact contours of that may take years to become clear.”

Also on Aug. 7, the fever of social media reared its not-so-ugly head. In truth, the fire ignited in July when internet-destroyer Kim Kardashian posted to Instagram and Twitter her love affair with Diclegis, a drug approved in 2013 for managing morning sickness. The FDA letter to proprietor Duchesnay USA, dated Aug. 7, states that the post is misleading because it presents various efficacy claims, but fails to communicate any risk information.

Whether this was an honest mistake, or a calculated maneuver, the damage is surely done, giving Diclegis substantial exposure, 460,000 likes worth.

But can FDA keep up with the Kardashians? The agency wrote its response, and the post came down. But even those without an eye on pharma can see, social media is a tough place for FDA and perhaps needs help from the likes of Twitter and Instagram to patrol themselves. She may not have broken the internet, but @KimKardashian did demonstrate just how broken the FDA’s approach to social media is.

Then on Aug. 18 came a decision that had been looming over the FDA for some time. Pressure had been building to equal the playing field in the pharmaceutical boudoir and give women their rightful equivalent to Viagra and its brethren.

A unique situation, FDA absorbed pressure from feminists, on both
sides, calling for approval and fairness, while others demanded

 rejection, and for drugmakers to come up with something better. Meanwhile, Sprout Pharmaceuticals sold efficacy and safety as it simultaneously played the sexual rights inequity card via its “Even the Score” campaign.

Industry critics have panned the decision to approve Sprout’s Addyi (examples here and here). Meanwhile, big Pharma quickly decided the asset was derisked, immediately gobbling it up for $1 billion.

Valeant, the acquirer, clearly sees the extensive risk evaluation and mitigation strategy (REMS) package as manageable, including its black box warning and severe language against mixing the once-daily pill with alcohol.

The 18-month radio and TV silence promised upon approval is fairly unique and virtually pointless, considering that millions of Americans have been made aware of the drug’s existence by the general media reflexively coining Addyi the female Viagra. As a result, the drug will capitalize on over a decade of men’s men doing manly things, happy couples, and dual bathtubs, even if the comparison to the little blue pill is untrue and misleading.

The agency was in a tough spot. Rejection would have been extremely distasteful for many. Given the pressures, FDA did what it could with the authoritative REMS package. But looking forward, has it spawned a new monster? Will other companies contend approval with massive pre-approval “activism” crusades? What is FDA’s response to pre-approval marketing that is untrue and misleading?

Casey McDonald is Pharm Exec’s Senior Editor. He can be reached at cmcdonald@advanstar.com.