Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!

Two days ago, I sent an email to FDA's "Bad Ad" program (email addr: BadAd@fda.hhs.gov) to cite a Pfizer iPhone App as a "Bad Ad" (see "Recipes 2 Go: Pfizer's LIPITOR-Branded iPhone App. Is It an Ad FDA Should Review?" for background). For the record, here's a screen shot of the email I sent (click on it for an enlarged view):

A minute later, I received an acknowledgement email from the FDA that started with "Thank you for taking the time to alert us to potentially misleading promotion," but ended with "If you are not a healthcare provider, please refer to the OPDP website for instructions on how to submit a complaint, or call (301) 796-1200." I was confused, so I called the number and left a message.

Today, Olga Salis, OPDP Senior Project Manager, called me back to explain the Bad Ad complaint process. It appears that "healthcare professionals" (i.e., mostly physicians) can submit complaints about ads via email whereas ordinary citizens such as myself MUST use snail mail; i.e., send a physical letter to FDA/CDER/OPDP, 5901-B Ammendale Rd, Beltsville, MD 20705-1266. This distinction is not clear from the information provided on the Bad Ad page here.

It's OBVIOUS that the FDA does not want to be bothered or flooded by consumer complaints because it is not making it easy for consumers to submit complaints. Who knows if FDA would have done anything with my complaint had I not called. As it is, it may take OPDP THREE months to respond or take action on my complaint, "if it has merit."

NOTE: FDA receives complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see figure below and also here):

Source: pharmamkting.blogspot.com via Pharma on Pinterest

I will followup with a written letter sent to OPDP. However, I encourage any healthcare professional reading this blog to download the Pfizer iPhone app in question and if you agree with me that it is worthy of a "bad ad" complaint to the FDA, then all you have to do is send an email to BadAd@fda.hhs.gov. Easy for you, not so  much for me :-(

DDMAC's Bad Ad Program Catches Pfizer Using Google Style "bAdWords" on Lipitor Web Site

This is rich!

Recall that back in April, 2009, the FDA sent 14 "warning" -- actually notice of violation or NOV -- letters to major pharmaceutical companies citing as violative several short Google Adwords such as this Pfizer sponsored Adword for CADUET (find the screen shot of this as archived by FDA here and the letter FDA sent to Pfizer here):

I called such ads "bAdWords" way back in November, 2006 -- 3 and one-half years BEFORE FDA caught on (see "Lunesta, Google, and 'bAdWords'").

Last week (August 31, 2011), DDMAC sent ANOTHER letter to Pfizer about some Google-style violative "AdWords" it found in the “Online Resources” webpage of the Pfizer, Inc. (Pfizer) website for LIPITOR. One of the ads was for -- wait for it -- CADUET! THAT ad looked like this:

The CADUET link ad above is practically IDENTICAL to the sponsored Google ad, which FDA warned Pfizer about more than 2 years ago!

Either Pfizer's legal/regulatory team has NO organizational memory, or it tried to pull a fast one on FDA.

It should be noted that FDA itself did not catch this. It was submitted to FDA's "Bad Ad" program; a name no doubt inspired by my "bAdword" blog post mentioned above. And it was probably one of those other 14 companies that received letters from the FDA in 2009 that ratted on Pfizer (see "Majority of Bad Ad Complaints Submitted by Pharma 'Representatives' Deemed Worthy of 'Comprehensive Review' by FDA").

[This post originally appeared in Pharma Marketing Blog. 

Make sure you are reading the source to get the latest comments.]

Majority of Bad Ad Complaints Submitted by Pharma "Representatives" Deemed Worthy of "Comprehensive Review" by FDA

According to a Bad Ad Program 2010-2011 Year End Report just issued by the FDA (see here), the program is a success despite the fact that ONLY 125 complaints were deemed worthy of "comprehensive review." The remaining 203 Bad Ad complaints were presumably filed away in DDMAC's circular file. Those 125 complaints worthy enough for review lead to 5 enforcement actions.

The agency "does not view the total number of reports, or number of enforcement actions taken as the primary measures for program success," said FDA in the report. "Instead, FDA’s most important measure of success for this program is the heightened sense of awareness of misleading promotion among HCPs throughout the health care community and the likely useful deterrent this awareness has on drug promoters who might run afoul of regulation absent of such messaging."

FDA received complaints from three sources: Healthcare Professionals (HCPs), Consumers, and "representatives of regulated industry" (ie, pharma companies ratting out their competitors). The "pharma" group of complaints was the most credible -- 58% of those complaints were deemed worthy for "comprehensive review," whereas 46% of HCP complaints and only 21% of consumer complaints made the cut (see chart below; click for enlarged view).

FDA says that the quality of complaints submitted by HCPs "demonstrates a relatively strong level of knowledge in the medical community about what constitutes misleading promotion." Since pharma's complaints were even MORE credible than those from HCPs, FDA should have said it "demonstrates a relatively strong level of knowledge in the PHARMA community about what constitutes misleading promotion."

It's not clear, however, if "representatives of regulated industry" include HCPs employed by pharma companies. At least one recipient of an FDA Bad Ad enforcement letter claimed the complaint came from such as source (see "Competitors Are "Best Source" of Complaints About Promotions Received by FDA").

[This post originally appeared in Pharma Marketing Blog. Make sure you are reading the source to get the latest comments.]

FDA's BadAd Program Lacks Credible Evidence

FDA's BadAd Program is "BadAss" Lately! What a difference a couple of weeks makes!

On April 25 I posted this: "FDA's Bad Ad Program is 'Phoniest Thing Ever!'," which documented that after one year, the FDA's BadAd program only resulted in one warning letter.

In the last few of days, however, the FDA has issued TWO warning letters that resulted from complaints received via the BadAd program. One (here) was dated 4/28/2011 and sent to Forest Laboratories, Inc. In that letter the FDA cited a sales representative’s statements as false or misleading because they promoted "unapproved uses for Savella, [made] unsubstantiated superiority and mechanism of action claims about the drug, and [minimized] the serious risks associated with Savella."

The other letter, dated 5/5/2011, was sent to Warner Chilcott (US) because of a video that a sales rep posted on YouTube, which was a pretty stupid thing to do. You can read about that on Phamalot.

Why the sudden increase in BadAd-inspired warning letters? Could it be that the FDA's recent webinar was effective in getting physicians to rat out pharma sales reps?

Even if the webinar was successful in generating more complaints, the FDA does not work THAT fast. In fact, the first letter I mentioned resulted from a compliant the FDA received ABOUT 8 MONTHS AGO on September 10, 2010!

Not only that, but the complaint was about ORAL statements made by a Forest sales representative on May 12, 2010, which is nearly a year ago! "On Wednesday, May 12, 2010, at approximately 1:15 p.m., a sales representative from Forest made an unsolicited sales call to a physician at his office," said FDA in the letter. Sounds like charges made by a prosecutor at a criminal trial!

Playing the role of defense lawyer, let me point out problems I have with the timeline.

First, why did the physician wait until September 10, 2010, to submit a complaint about something that happened 4 months previously? Did he/she just learn of the BadAd program in September? If so, then the only evidence the FDA has to support the complaint is the physician's affidavit that the complaint is true. THAT'S HEARSAY EVIDENCE!

Suppose the physician RECORDED the conversation with the rep? If he/she did that, then the motive must have been to make a complaint to the FDA. But why sit on it for 4 months? WE SHOULD INVESTIGATE THIS PHYSICIAN'S MOTIVES. Maybe we can discredit him/her on the stand.

But wait, there's no trial. And there's no credible evidence such as violative detail aids, brochures, etc., which the FDA usually refers to in warning letters regarding sales rep misconduct.

No wonder the FDA is not being very transparent about its BadAd program. We can get some interesting information just by reading the letters. Imagine what we can learn if more details about complaints were released.

Competitors Are "Best Source" of Complaints About Promotions Received by FDA

Approximately 12 minutes into yesterday's 45-minute "Bad Ad Program Webinar," Catherine Gray, PharmD, Management Advisor at DDMAC, got down to business and started talking about the program that some critics have said is "ineffective, not cost-effective, and biased" (see poll here). At that point, Gray talked about "Limitations" of FDA's drug promotion surveillance. She focused on promotions to physicians.

Among FDA's TOP three "normal" surveillance activities was "complaints submitted by industry competitors." In fact, Gray said "we have found that industry competitors tend to be some of the best sources of information about potentially false and misleading advertising."

I am not surprised that competitors complain to the FDA. I've spoken to industry people who read this blog because they like to see me blast their competitors. For example, when I speculated that Phil Mickelson was on the AMGEN/PFIZER payroll when he said glowing things about ENBREL in the press (see "Is Phil Mickelson Shilling for Enbrel?"), a competitor told me that his company wondered the same thing.

Of course, even competitors cannot hear what's said "behind closed doors" in physician offices, industry-sponsored dinner and lunch programs, and on the floor at major medical meetings. The FDA initiated its BadAd program to "fill these gaps" in its surveillance activities. Thus, the BadAd program is designed to solicit complaints from physicians about verbal statements made by company sales reps or company-paid speakers.

When asked "In cases where there is a complaint about an oral statement, what evidence standard do you use to go forward with an action," an FDA speaker responded: "We have a very high level of evidence that we require that often includes an affidavit ... and verification as well. So, we do have a very high ... standard of evidence that we require before taking enforcement action." No further details were given.

However, in response to another question, FDA said they also accept anonymous complaints, which obviously cannot be substantiated by an "affidavit." FDA does not reveal how many of the 239 BadAd complaints it received in 2010 were from "anonymous" sources, but given the fact that competitors are likely to be a major source of complaints, I image that a good deal of BadAd complaints are anonymous and likely to be worthless.

Of course, some companies are just too dumb not to leave a trail of verifiable evidence, such as Hill Dermaceuticals, which had a nice public website the FDA could plainly see violated its regulations (see FDA's Bad Ad Program is "Phoniest Thing Ever!" and screen shot below).

No wonder then that the Hill Dermaceuticals case was the ONLY BadAd complaint that resulted in a notice of violation letter. Does the FDA need a BadAd program for that? BTW, Jerry Roth, president of Hill Dermaceuticals, complained that DDMAC acted on a complaint filed by "a doctor for another [competing] company." Mr. Roth should THANK the FDA for giving his company some GREAT promotion!

Aside from violative verbal statements, the FDA's BadAd program is designed to capture complaints specifically about "Home-made promotional materials not submitted to FDA."

How rampant is the use of "home-made promotional materials" by pharma sales reps? It must be significant if the FDA specifically mentions it as a reason for the BadAd program, which don't forget, was created by "2 former sales representatives with 11 years combined selling experience." These former reps, said Gray, "are well aware what goes on behind closed doors." Perhaps these two former reps engaged in questionable promotion to physicians themselves? Gray added that they were "quite successful in selling their products."

My impression of the BadAd program is that it was created by former drug industry sales professionals and is designed to make it easier for sales reps and company-paid physicians to "rat out" their competitors, anonymously or not. It just doesn't present a good image of how a government agency should work. In fact, I am sure that under a new administration, the BadAd program will be the first item on the agenda for cutting. While it may be easy these days for a drug rep to begin a career in the FDA, I am not so sure a former drug rep FDA staffer will be able to get a job in the drug industry after being laid off due to budget cuts!

FDA's Bad Ad Program is "Phoniest Thing Ever!"

So says Jerry Roth, president of Sanford, Fla.-based Hill Dermaceuticals. His company received the ONLY letter from the FDA as as a result of a complaint received via DDMAC's (Division of Drug Marketing, Advertising, and Communication) Bad Ad Program (see here).

According to Advertising Age, FDA received 239 complaints to the Bad Ad program from its launch in May through January of this year. "Of these complaints, 129 (54%) have come from health-care providers, 73 (31%) from consumers, and the remainder from other sources. Of the 239 complaints, approximately 135 were deemed to have sufficient merit for further investigation, with approximately 50% falling within DDMAC oversight and the rest being referred to other centers within FDA."

According to DrugWonk's Peter Pitt, "At best this effort isn’t, um, cost effective" (see here).

I myself submitted a compliant to the FDA regarding this Lyrica DTC Ad. I didn't get any response from the FDA due to this "technical glitch" in the auto-response to submissions to its BadAd program. The belated response came from "Bob Dean," the lead consumer safety officer for DDMAC. Dean worked as Senior Specialty Sales Representative at Johnson and Johnson for five years and as a Sales representative at UCB for 2 years (see his LinkedIn profile).

Mr Roth claims DDMAC acted on a complaint filed by "a doctor for another [competing] company," which is interesting. The FDA solicited complaints from doctors because "prescriber[s] can play an important role in ensuring that prescription drug advertising and promotion is truthful by recognizing and reporting misleading drug advertising and promotion." But because so many -- perhaps up to 80% of -- "prescribers" are employed directly or indirectly by pharmaceutical companies, the Bad Ad program is open to criticisms similar to Mr Roth's.

Roth also said "I sell my products at around $50 a prescription when the average prescription is near $200. So you figure out why they came after me." Given Mr. Dean's background in Big Pharma, I can feel Mr. Roth's pain!

The letter Hill Dermaceuticals received cited that certain pages on the company's website were "false or misleading because they omit and minimize the risks associated with the use of Derma-Smoothe Body Oil, overstate its efficacy, present unsubstantiated superiority claims, broaden and inadequately communicate the indication, and present unsubstantiated claims for the drug product." This is interesting because that's EXACTLY what I said about Pfizer's Lyrica DTC Ad!

The question is, Is FDA's Bad Ad program biased, ineffective, not cost effective, or all of the above? Take my little survey and tell me what you think.

Do you think FDA's Bad Ad Program is:
	Ineffective
	Biased
	Not worth the cost
	All of the above
	None of the above

P.S. FDA is hosting a Bad Ads Program webinar titled, "An Overview of the FDA’s Bad Ad Program," on Thursday, at 12 Noon (ET), April 28, 2011 (see here). Catherine Gray, Pharm.D., will present an overview of the FDA’s "Bad Ad" program, specifically focusing on how to identify misleading prescription drug promotion and report this activity to the agency.

Pharmaguy Alerts FDA About BadAd Technical "Glitch"

I just received an email message from the FDA thanking me for calling their attention to a "technical glitch" in the auto-response to submissions to its "BadAd" program (see email message reproduced below; click on it for an enlarged view).

It's gratifying to know that I have been of service to my country. I wonder, however, why this "glitch" wasn't noticed until now. The BadAd program was launched by the FDA in May 2010 (see press release).

It's impossible to know how many people/HCPs like me submitted a report about a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. "While we cannot provide status updates on ongoing investigations to persons outside the Agency," says the FDA, "health care providers can subscribe to our e-mail updates to receive information about the program and notifications of actions taken as a result of the program."

It appears that I have been subscribed for quite some time, but have not received any notices until today. It reminds me of the time I submitted a complaint to PhRMA's Office of Accountability (see "PhRMA's Response - PRwise, it Stinks!").