Tuesday, March 15, 2011

Today’s FDA Advisory Committee Meeting, Brought To You By …

… FedFinancial Federal Credit Union, serving federal employees and their families in the Washington and Baltimore areas since 1935.

OK, so maybe the credit union was not the “sponsor” of Arcapta Neohaler, the chronic obstructive pulmonary drug reviewed by FDA’s Pulmonary-Allergy Drugs Advisory Committee on March 8 (the NDA sponsor is Novartis).

Nevertheless, the bottled water provided to committee members and FDA staff was courtesy of FedFinancial. The bottle’s label bore the credit union’s name and the slogan “Member Benefits Set Us Apart.” Also, included were the credit union’s toll-free phone number, website and the location of a branch office at FDA’s White Oak headquarters (Building 2, Room 1041).

As jaded attendees of FDA advisory committee meetings, the seemingly innocuous, though incongruous, presence of a promotional item struck us as odd, so we investigated further with the assistance of fellow colleagues from “The Pink Sheet."

(Full Disclosure: This reporter took a warm, unopened bottle of FedFinancial water following the Arcapta meeting because agency staff removed her personal bottle of water during their aggressive clean-up efforts of the White Oak Conference Center.)

Similarly labeled FedFinancial water was provided to the head table two days later at the Anesthetic and Life Support Drugs Advisory Committee’s March 10 meeting on pediatric use of sedative/anesthetic agents. Both the Pulmonary-Allergy and Anesthetic-Life Support committee meetings were held at FDA’s White Oak campus.

In contrast, the Peripheral and Central Nervous System Drugs Advisory Committee convened at the Hilton in Silver Spring, Md., on March 10 to discuss a monotherapy indication for GlaxoSmithKline’s anti-seizure drug Lamictal XR. No FedFinancial water for that meeting, however, as committee members and FDA staff had to make do with pitchers of water provided by the hotel.

So, what gives? In these desperate fiscal times, is FDA so tight on funding that it has turned to financial institutions to help defray costs of holding advisory committee meetings?

Not so, the agency says. In response to a question from “The Pink Sheet,” the CDER trade press office had this explanation:

“The water bottles just happened to be left over from a function within CDER in which the credit union, which has a branch on campus for employees, supplied water. The credit union did not (at least not intentionally) provide water to staff and panel members for last week’s meetings.”

So, that’s that. And yet, we can’t seem to let this go, because seeing high-level staff in FDA’s Office of Drug Evaluation II and the Division of Pulmonary, Allergy and Rheumatology Products swilling FedFinancial water gave us an idea.

What if FDA were to offer promotional opportunities during the course of its advisory committee meetings? Oh, we’re not talking about allowing Boehringer Ingelheim and Pfizer to advertise their COPD drug Spiriva during the committee’s review of Arcapta, as that would be an obvious conflict.

Instead, why not offer non-pharma companies, such as vendors or service providers, an opportunity to sponsor ads or “commercial breaks” in the meetings? We can see it now:

A full-page ad, attached to the meeting agenda, highlighting the Silver Spring Hilton’s banquet facilities as the perfect place for that Fall 2011 wedding reception.

The panel chairman’s announcement of the mid-morning meeting break: “The morning break is sponsored by Roto Rooter Plumbing and Drain Service, where their motto is ‘And away go troubles down the drain.’”

Or, “The voting results on Arcapta’s efficacy and safety are brought to you by the international accounting firm Ernst & Young. Ernst & Young – Quality in Everything We Do.”

Then again, the text of voting questions and the electronic voting process itself tend to cause so much confusion among advisory committee members that no reputable accounting firm might want its name attached to the process.

We’ll keep working on this one while we sip our FedFinancial water.

– Sue Sutter (

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