FDA Targets Genetic Testing Services for Advertising Unapproved "Medical Devices"

FDA recently  (May 11, 2011) sent letters to two DNA testing services concerning their Direct to Consumer (DTC) advertising. The companies are Precision Quality DNA (see letter here) and Lumigenix Inc (see letter here).

Precision Quality DNA, offers a service intended to help individuals "understand the analysis of their DNA sequence while focusing on main target genes, such as BRCA1/BRCA2, to determine that individual’s main risk factors or likely response to a particular drug." FDA claims that the service "appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act."

Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“... an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or] intended to affect the structure or any function of the body of man or other animals.”

FDA looked high and low in its files and "ha[s] been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Precision Quality DNA. We request that you provide us with the FDA clearance or approval number for the Precision Quality DNA . If you do not believe that you are required to obtain FDA clearance or approval for the Precision Quality DNA, please provide us with the basis for that determination."

Actually, Precision Quality DNA does NOT believe it requires FDA clearance and says so right on its website on a page titled "Health, Politics and Regulatory Issues" (see here). On that page, Andre Gous, Co-Founder of the company and addressee of FDA's letter, has some interesting things to say about the FDA and its authority to regulate software as a medical device, including:

"Even if you're in favor of government regulation, you're probably wondering how a 1976 FDA law could be applicable to DNA biotech -- an entire field of endeavor that was unknown to the legislature at that time. And, since that law focuses on devices, the FDA is (no surprise) also classifying more and more things, even things as ethereal as software, as a 'device.'

"If the FDA were simply deluded, that would have been bad enough already. However, the FDA didn't stop there. They mailed intimidating letters to the top 5 DNA biotech US companies, and since then they have mailed out 14 more such letters yet."

After that it's pretty much an Ayn Rand style rant; ie, government should just leave capitalists alone.

My guess is that Precision Quality DNA was not among the the "top 5 DNA biotech US companies" that previously received letters from the FDA. To paraphrase it's marketing tag line, Precision Quality DNA "Dodged the Bullet with its Name on it" from the FDA in the past, but now has to deal with that bullet. It will be interesting to see who prevails, the bullet or the target.

How FDA, in Cahoots with DOJ, Brought Google Down

FDA’s Infamous 14 Warning Letters were a Ploy to Force Google into a $500M DOJ Settlement Regarding Illegal Online Pharmacy Ads

“…something is happening here and you don't know what it is, do you, Mr. Jones?”

That’s how I’m feeling today as I try to understand what’s really behind the news about Google’s advertising policies, online pharmacies, and FDA’s 2009 warning letters to major pharmaceutical companies. If my thinking is correct, drug industry search engine ads were “collateral damage” in a war between Google and the FDA.

Yesterday, the Wall Street Journal reported that Google is “close to settling a U.S. criminal investigation into allegations it made hundreds of millions of dollars by accepting ads from online pharmacies that break U.S. laws” (see “Google Accepted Ads from Illegal Online Drug Stores”).

Not so coincidentally, a few days ago, Google disclosed that it was setting aside $500 million to potentially resolve a case with the Justice Department (DOJ) that involved "the use of Google advertising by certain advertisers."

“The investigation has examined whether Google knowingly accepted ads from online pharmacies, based in Canada and elsewhere, that violated U.S. laws,” said the WSJ article.

The FDA has long struggled to rein in American’s penchant for buying drugs from online Canadian pharmacies and this investigation of Google by DOJ is likely part of that effort. But, as I surmise below, caught up in the case may have been legitimate major pharmaceutical companies as well.

Consider FDA’s infamous 14 warning letters that the agency mysteriously sent in a single day in March, 2009, to major pharmaceutical companies about Google Rx Adwords, saying the ads were misleading because they didn't include risk information (see “FDA Warns Drug Firms Over Internet Ads”).

Could that have been a “ploy” to bring Google to its knees and cave in regarding online pharmacy ads?

In other words, the FDA’s warning letters may have been a “shot across Google’s bow,” intended to force Google to halt its acceptance of ads from “illegal” online pharmacies. FDA could have been saying, “What’s more important to you? Ads from online pharmacies or ads from major pharmaceutical companies?”

FDA’s actions were a strong incentive because "sponsored link exposures to U.S. Internet users declined more than 50 percent immediately after ... FDA warning letters were issued to pharmaceutical manufacturers," according to a comScore study (see “FDA Letters Caused a Prompt, Precipitous, & Prolonged Drop in Pharma Paid Search Engine Advertising”).

It’s likely that this case goes way back because in September 2010, Google disclosed that it had filed a lawsuit against “advertisers we believe have deliberately broken our rules,” in particular involving “rogue online pharmacies” that “illegally sell drugs on the Web” (see “Google’s $500M Charge Related To Pharma Advertising Probe”).

In June 2010, I reported that Google launched a NEW Rx drug ad format that includes everything FDA requires that a drug company include in its direct-to-consumer advertising: fair balance, and direct links to side effects, precautions, dietary information, etc. (see “Finally, A Google Drug Search Ad Format That Has All FDA Could Want... But Pharma Can't Use It!”). The “ads” are really more like public service announcements. They come from National Institutes of Health (NIH) and compete with paid ads from pharmaceutical companies who cannot use the new format (see “Google's New OneBox Rx ‘Ads’ Steal Clicks from Organic Branded Rx Search Results”).

To compensate for that deficiency, Google also has come up with a new ad format for the industry (see “Is Google the New FDA?”).

All of these actions by Google could be designed to appease FDA and DOJ and regain the drug industry’s ad revenue lost as a result of FDA’s warning letters way back in 2009.

You have many contacts among the regulators
to get you facts when someone attacks your advertising
but nobody has any respect, anyway they already expect
you to all give a check to FDA and other organizations
Ah you've been with the professors and they've all liked your looks
With great lawyers you have discussed clicks and sidewikis
You've been through all of Ayn Rand’s books
You're very well read, it's well known
But something is happening here and you don't know what it is
do you, Mr. Pharma?

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.

ACCME's Dirty Little Commercial Funding "Secret"

Having nothing better to do on a Saturday morning, I posted results of my latest analysis of sources of Continuing Medical Education (CME) funding reported by ACCME (Accreditation Council for Continuing Medical Education) in its 2010 annual report (see "Pharma Support for Accredited CME Continues to Decline"). I was tardy in doing this yearly task -- the report was made public last July. Better late than never.

The real reason why I posted my ACCME analysis over the weekend, however, is because I had in my hands a study of physician attitudes about commercial support of continuing medical education that was going to be published on Monday and the data was relevant to the post I made after the study was published (see "Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!").

In the meantime, Derek Warnick (@CuratioCME), CME Director at Curatio, an ACCME accredited medical education company (MECC), posted a response to my analysis of the ACCME data (see "Response to CME Post on Pharma Marketing Blog"). Derek takes issues with many points I made in my analysis, but the most interesting comment he made was this:

"I’m going to let you in on a little secret (although, if you work for an accredited CME organization, you probably already know this): those numbers used by the ACCME to report Total Commercial Support? Yeah, they’re not as cut-and-dried as you might think. Sure, you can look at them and say, “Hmmm... looks like MECCs are getting a LOT less commercial support.” But here’s the thing: the Total Commercial Support numbers you see only reflect the amount of commercial support given directly to the accredited provider sponsoring the activity [Derek's emphasis].

"So, if there is an activity that is co-sponsored by two accredited organizations, the organization responsible for certifying the activity is the organization that receives the commercial support. They then re-distribute the money to the other organization for their role in the activity. Typically, the organization that directly receives the commercial support reports the entire amount to the ACCME; the other organization doesn’t report anything. This has been my experience. The ACCME does allow the option of each organization individually reporting their split amount of the grant, but that gets pretty confusing if you have a lot of activities and lots of partners. The ACCME is fine with it either way; [Derek's emphasis] they just don’t want the money 'double-reported'."

This raises a couple of interesting question. First, however, let me say that this may not be as big a secret as Derek thinks.

In July, 2008, Pfizer announced that it would no longer directly fund CME courses provided by for-profit, third-party companies (MECCs) although it would keep paying for courses offered by medical schools, teaching hospitals and medical societies. Shortly after that, I hosted a survey (see "What's the Best Way for Pharma to Support CME?") that asked respondents if they thought all pharmaceutical companies should follow Pfizer’s lead. The following chart shows the results:

An anonymous respondent clued me in on the "little secret" Derek referred to in his post:

"Med schools, teaching hospitals, and medical societies frequently use MECCs to create their CME anyway, and unless CME is funded by pooled grants (ie, from multiple pharma companies), the bias will be no less than it is in the MECCs, or not much less."

Derek claims that because of this kind of "subcontracting," MECCs may not be getting as small a piece of the CME funding pie as I estimated from the ACCME numbers. Fair enough. But I note that only a small fraction of MECC respondents to my survey thought it was a good idea for other pharma companies to follow Pfizer's lead. That's understandable, because MECCs would have new academic bosses to deal with who may nickel and dime them. It's much better to get your slice of the pie direct from the baker than to beg a piece of someone else's slice!

I think Derek agrees with my analogy. He said:

"How often does this happen? Well, I can’t really speak for other companies, but my guess is it hapens (sic) a lot more frequently then it did 5 years ago. As already mentioned, the Pfizer’s and OMJ’s of the world no longer provide commercial support to MECCs. That eliminates a pretty big chunk of money that MECCs used to report to the ACCME. The alternative now is to find another accredited partner, such as a medical school or physician society, to co-sponsor the activity. That medical school or physician society is the accredited provider and they receive the commercial support. So in the past, where a MECC would have directly received a $100,000 grant from Pfizer (and reported it all to the ACCME), now a co-sponsor receives the $100,000 grant, reports it all to the ACCME, and then sends $50,000 to the MECC (or whatever the split is) for their role. That’s a $200,000 swing in how the commercial support is reported to the ACCME, when in reality the actual difference is only half that. Again, the ACCME is OK with this."

So, Derek and I agree that MECCs are losing more than just crumbs from the pie, but we differ on exactly how big the pieces really are. The more important issue, however, concerns bias. Is there any less bias in commercially-supported CME if industry funding in channeled through medical schools and medical societies to for-profit MECCs than if the funding went directly to MECCs?

Further reading:

• "Waning Pharma Support of CME: The Plight of For-Profit MECCs"

eDetailing Technology Spells Death of Traditional Pharma Salesman & Birth of "Sales Cyborg"

"You can't eat the orange and throw the peel away - a man is not a piece of fruit," says Willy Loman in Act 2 of Death of a Salesman. After reading this article in today's Wall Street Journal, many pharma sales reps may be feeling like tossed peeled fruit.

"Big pharmaceutical companies have found replacements for the army of sales representatives they've laid off in recent years: digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit," says the WSJ.

"Tens of thousands of pharmaceutical sales reps have been eliminated in the U.S., creating a void that drug makers are now increasingly filling with websites, iPad apps and other digital tools to interact with doctors who prescribe their treatments."

Let's refer to "digital sales tools that seek to sell doctors on drugs without the intrusion of an office visit" as "eDetailing."

eDetailing in one form or another seems to be making a comeback since the recession hit the drug industry in 2007 and 2008 (see chart on right). I'm not really sure which is the "chicken" and which is the "egg"; ie, whether an uptick in adoption of eDetailing technology lead to the recent layoff of pharma reps or if reps were laid off because of the economy and subsequently replaced by machines.

Despite the title of this post, reports of the death of pharma "salesmen" may be somewhat exaggerated and not all sales reps can be replaced by machines. According to the WSJ:

"When German drug maker Boehringer Ingelheim GmbH launched the cardiovascular drug Pradaxa in the U.S., it put together a digital-marketing package to target doctors, including organizing webcasts for leading physicians to speak to other physicians about the drug. But the company found that sales calls to doctors' offices were still the most powerful tool for driving new prescriptions, says Wa'el Hashad, vice president of cardiovascular and metabolic marketing. 'No doubt digital marketing does have an impact...I don't believe, however, the shift happens overnight. I think it's a gradual shift,' he says."

In the Pharma Marketing News article "The Changing Role of Pharma Sales Reps," Nancy Lurker, CEO of PDI, Inc., says "reaching physicians requires a new level of sophistication. Live rep calls and dinner meetings and other live venues, however, are not going to go away. But the relative market share in terms of the amount of effort and money that is spent on live interactions is going to shrink and you’re going to see more money being spent in the digital communications space."

Some sales reps will morph into what I call "sales cyborgs" who engage in remote live human conversations with physicians aided by technology. See "Pharma TeleWeb e-Detailing" for more information about that.

Predicting the Impact of Technology on Sales
As of now, pilot programs such as TeleWeb e-Detailing have not been evaluated on how well they drive sales, but on other key indicators of success. Notwithstanding push back by some pharma marketing and sales managers, sales technology will continue to evolve and have greater impact in driving new prescriptions.

Back in 2006, Pharma Marketing News hosted a reader survey to predict future trends in the pharmaceutical marketing mix (see survey summary here).

The survey asked readers for their opinions regarding the impact and risk of several physician marketing channels. They were also asked how they saw the mix shifting in the next few years.

When evaluating impact, I asked respondents to think of reach, credibility, and content richness as important factors -- the greater these attributes, the greater will be the impact. Risk factors, on the other hand, include potential to cause customer dissatisfaction or push back, increased regulation, negative publicity, etc. If marketers should avoid the channel, then risk would be high.

The results of the survey can be plotted in graphical form:


Let's focus on traditional face-to-face promotion (rep) and eDetailing or epromotion.

While face-to-face promotion has a very high impact potential it is also risky and is becoming even more risky, according to survey respondents. [Risky because of increasing physician push back, denying reps access to physicians, and state laws attempting to limit access to physicians by sales reps.]

This is what the downward red arrow is showing. In fact, the tip of the arrow is where this channel may be at today!

eDetailing or ePromotion also has high impact. At the time this survey was run, eDetailing was thought to be as “risky” as face-to-face selling, but now it has the potential at least of being LESS risky and MORE impactful than traditional sales reps.

Additional Reading:

• Internet vs. Sales Reps: Which Do Docs Prefer?
• Rejiggering the Marketing Mix a la Merck

P.S. Forgive my use of the terms "salesman" and "salesmen." Obviously, I am trying to relate this to the play "Death of a Salesman." I am not implying that all pharma sales reps are men. Some reps are actually "cyborgs" with limited sexual attributes and some are machines that have no sex whatsoever!

Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!

Talk about having your cake and eating it too! Commercial funding of continuing medical education (CME) and the potential for bias appear to concern many physicians, yet only a TINY MINORITY (7%) are willing to pay registration fees to eliminate or offset commercial funding sources, according to a report in the May 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Maybe physicians would like ObamaCME; ie, government subsidy of their education?

No, not quite. But they are willing to give up certain things to reduce costs such as eliminating a printed syllabus. They are not, however, keen to give up the free coffee and snacks!

The authors surveyed attendees at live CME courses delivered by the International AIDS Society–USA (IAS-USA), a nonprofit organization that pools the support it receives from industry so that no one company funds any particular program. In total, 770 attendees (a 57% response rate) completed the 22-item survey, which focused on beliefs about commercial funding and potential for bias, willingness to offset the cost of commercial support, knowledge about the costs of producing CME programs, and demographic information.

Although the study surveyed nurses, nurse practitioners, physician assistants, and persons with Ph.D.s or other academic degrees as well as physicians, I'll just focus on the responses from physicians (N = 378).

Potential for Bias
Although he authors never specifically define what they mean by "bias," I think we all know they are referring to influence over the content of CME courses in such a way as to benefit the commercial supporter.

There are several opportunities for bias to creep into CME, all of which involve money from drug and device companies:

• Faculty members' research may be supported by grants from companies
• Faculty members may be paid members of company speaker bureaus
• Faculty members may be paid directly to speak at CME programs
• The CME program itself is supported to some degree by a grant from a single or multiple companies

Of course, some CME programs are not funded in any way by the drug industry and is paid for entirely  from registration fees paid by physicians (the Institute of Medicine estimates that physicians, on average, spent slightly more than $1400 per year for CME in 2007).

The survey asked physicians how they would rate the bias of CME programs under each of these scenarios. The results are presented in the chart below:

This chart shows the percentage of physician respondents who believe the listed CME funding options have a moderate or large potential for bias.

According to the respondents to this survey, the least potential for bias in CME is when the faculty is completely independent; ie, receives NO funding of any sort from the drug/device industry. However, that is an unlikely scenario given the fact that perhaps 80% of the CME faculty pool receives some form of funding from pharma/medical device companies.

"Speakers will continue to have relationships with industry in various ways, especially for research funding," noted authors of a commentary that was published in the same journal as the report. "Bias will always need to be addressed through speaker disclosures and direct monitoring for bias at CME events."

Given that so many physicians feel that pharma support of CME introduces bias, you would think they would want to eliminate that support. Actually, only 17% of physicians surveyed agreed strongly or somewhat that commercial support of CME should be eliminated entirely (see chart below) and 56% agree that "Pharmaceutical/medical device company support is essential for accredited CME and should not be eliminated" (data not included in following chart).

Physicians were asked what they would be willing to do to "eliminate the need for pharmaceutical/medical device company support" of CME activities they attended. The choices are shown in the list in the above chart.

Only 50% of physicians would give up free food or snacks to eliminate the need for commercial support of CME. BTW, these costs are substantial. Hotels -- where most live CME programs are held -- charge as much as $8.47 for a cup of coffee! "A $9 cup of coffee may not seem to be the most economical use of CME dollars," noted the authors of the study.

It's the Internet Age, Stupid!
Reducing the cost of CME seems to be the best way to eliminate the need for commercial support.

"Barring a substantial reduction in the cost of delivering CME, however, a rapid reduction or elimination of funding might be unacceptably disruptive, and some have postulated that such a change will result in the disappearance of live CME as we know it..." said the authors.

What better way to reduce costs than by delivering CME via the Internet? The survey did NOT ask if physicians would participate ONLY in online CME programs if that meant eliminating the need for commercial support. In fact, more and more physicians are receiving CME credit online (see "Pharma Support for Accredited CME Continues to Decline").

Yes, delivering CME via the Internet would "result in the disappearance of live CME as we know it," but that's a good thing, not a bad thing, given the exobitant costs and biases in the CME as we now know it, IMHO.

SURVEY
What do you think? Take my survey, which asks some of the same questions the authors asked physicians in their study.



SURVEY: Potential for Bias in Commercially Supported Continuing Medical Education