Reminder Ads OK in EU But Not in US. Huh?

The Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) expanded its practice code to cover all interactions with health-care professionals, medical institutions and patient organizations, including a ban on doctors from receiving payments to attend conferences (see "Big Bad Pharma, Bribery and the New EU Industry Code").

According to the above cited source (WSJ's "Corruption Currents" blog) this was a bit like closing the barn door after the cows have left:

"This comes at a time when the association’s members are trying to drum up business in developing countries, some of which have state-run health systems. Employees of such systems, including doctors and nurses, can be considered foreign officials under the U.S. Foreign Corrupt Practices Act, a 1977 law that bars bribing foreign officials for business purposes.

"To that end, the Securities and Exchange Commission and the Justice Department are in the midst of a sweep of the industry. In April 2011, Johnson & Johnson agreed to pay $70 million to resolve violations, and The Wall Street Journal reported in November 2011 that Pfizer Inc. will pay more than $60 million when its settlement gets finalized.

"Both companies, the Journal reported, ratted on their competitors.

"Those competitors included AstraZeneca, Merck & Co., Bristol-Myers Squibb Co., GlaxoSmithKline PLC and others that have disclosed investigations for possible FCPA breaches. Eli Lilly & Co. was in advanced talks in April 2011 with the Justice Department, and the company said Feb. 24 in its annual results it’s at the same level with the SEC.

"Letters of inquiry to several of the companies, dating back more than a year, laid out several types of of possible violations: bribing government-employed doctors to purchase drugs; paying company sales agents commissions that are passed along to government doctors; paying hospital committees to approve drug purchases; and paying regulators to win drug approvals."

Any way, I decided to download the new "IFPMA Code of Practice" to see if there was anything interesting or actually new (you can find it attached to the post here). The code is intended to cover "interactions with healthcare professionals, medical institutions and patient organizations, and the promotion of pharmaceutical products."

This section popped out at me:

5.2 Reminder Advertisements

A “reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For “reminder” advertisements, “abbreviated prescribing information” referred to in Article 5.1 above may be omitted. 

The "abbreviated prescribing information" include "an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications, precautions, and side-effects."

In other words, it is perfectly OK to promote drugs to healthcare professionals and patient organizations using reminder ads that do not include safety information. Note: these ads must be print ads in professional publications because no such ads would be allowed on mass media such as TV, which reaches consumer audiences. Promotions  of Rx drugs to consumers is not allowed in the EU, reminder ads included.

The U.S. pharma industry does not have a "practice code" for advertising or "marketing" to healthcare professionals, medical institutions and patient organizations. It does, however, have "Guiding Principles" for direct-to-consumer (DTC) advertising, published by PhRMA (the U.S. industry trade association) in December, 2008. Principle 13 states "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised." I.e., NO REMINDER ADS!

Of course, PhRMA's principles leave open the door for running DTC PRINT ads, although I haven't seen many of these in the consumer publications I read. The exception is BOTOX, marketed by Allergan, which has NOT signed on to PhRMA's principles (see "PhRMA Intern vs. BOTOX!").

So, why does the IFPMA Code of Practice specifically carve out an allowance for "reminder ads?" Is that a technique often used in the EU to win over the hearts and minds of healthcare professionals? I don't get it.

Allergan "Badly Let Down" by Employee Tweet

The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Allergan breached UK pharma's self-regulatory Code of Practice because an employee accidentally tweeted publicly about Botox (read the details here "Brits Versus Botox Tweet").

Basically, an employee sent a public tweet to a friend in which he/she mentioned Botox and said "... we could do something around stroke rehab..." That was considered advertising to the public, a no-no in the UK and the rest of the world outside the U.S.

But PMCPA showed compassion saying that it noted that Allergan had a policy that clearly stated "no Allergan employee might comment in a social media forum about Allergan products or business activity."

PMCA added "The Panel considered that Allergan had been badly let down by its employee."

I sure would like to see Allergan's "Global Social Media Policy." I wonder if it is similar to Pfizer's infamous "social media playbook?" (see here).

Maybe Elya Zarra, who is currently part of Legal Department - Regulatory Affairs/Compliance at Allergan would send me a copy. Part of her duties include "Development and implementation of internal policies and strategies, including a global social media policy" (see her LinkedIn profile). I can't send her a direct message through LinkedIn because she requires contact only through her LinkedIn friends. And she doesn't have a Twitter account that I can find. Perhaps it's against policy for her to have one.

Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance

Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis filed a "citizen petition" with the FDA yesterday, urging the agency to "establish comprehensive, clear and binding regulations [my emphasis] to guide the industry" in communicating off-label drug information to physicians and payers. You can find the petition here.

Greg Kuetreman, writing about this petition in a post to Lilly's corporate blog (LillyPAD), said "we’re not asking for a change in the regulations -- just clarifications that will help us communicate in a better way." But this is not what the petition says. As I quoted above, the petition is asking for "comprehensive, clear and binding regulations."

In addition to specifically asking for regulations, rather than non-binding guidelines, there are a few other interesting points to make about this "petition" that are relevant to whether or not FDA will be able to issue social media guidance this year (or ever):

The petition asks for regulations regarding manufacturers responses to "unsolicited requests" from physicians for off-label information.

The word "Internet" and the phrase "social media" do not appear in the petition.

"Patients" and "consumers" also are NOT mentioned.

I find these points to be interesting because I recently reported that the FDA 2011 guidance calendar includes guidance for "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet" (see "FDA Drops Social Media from Its 2011 Guidance Agenda"). Whether or not such guidance would satisfy the 7 pharma petitioners with regard to "unsolicited" requests is open to debate.

According to the FDA (see here), a citizen's petition is a way to "influence the way FDA does business... change or cancel a regulation, or to take other action." The agency receives about 200 petitions yearly. "Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court."

Since this petition specifically addresses the unsolicited request issue for which FDA planned to issue guidance (see "First FDA Social Media Guidance to Address Responding to 'Unsolicited Requests' for Off-label Information"), that guidance will have to be delayed possibly more than a year while the agency reviews the petition.

If the petitioners are not satisfied with how the FDA responds to the petition, they are likely to "take the matter to court" further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media").

Last week, at the Pharma Virtual Sales & Marketing Summit, I asked Craig Delarge, Director of Healthcare Professional Relationship Marketing at Novo Nordisk, when he thought FDA would issue social media guidance for the industry. His personal opinion was "not in the foreseeable future." That comment surprised me at the time, but now I understand why he said it.

P.S. STRANGE COINCIDENCE?
Pharma's Citizen Petition was filed on the SAME day (July 5) that DDMAC Director, Tom Abrams, said that "publishing social media guidelines for industry is the division's 'highest priority,' and that the document will be 'published as soon as it's vetted.'" Abram's comments were made at the Drug Information Association’s in Chicago (see here).

Lilly's Greg Kuetreman attempted to answer the question "Why Now?" in his blog statement, saying "Because there continues to be some confusion about what companies can - and cannot - say to health care professionals, payers, and patients about new scientific information." Considering that there's ALWAYS been this confusion, Kuetreman's statement fails to answer the question. I think the answer is that pharma anticipated imminent release SM guidelines by the FDA and wanted to delay that release by filing a Citizen Petition.

[This post originally appeared in Pharma Marketing Blog. 

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

"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan's Suit Against FDA Paid Off!

Allergan -- the company that markets Botox legally for wrinkles and illegally for other things -- agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems "reasonable," which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a "reasonable" settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA's DTC Guidelines as well as PhRMA's Guidelines for Interactions with Healthcare Professionals (see "Allergan Doesn't Comply with PhRMA Guidelines, Wins Kudos Anyway"). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see "FDA Reads My Blog: Declares Latisse Web Site Misleading").

You must read a bit further down in the media articles about this to learn that Allergan "is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses."

There's a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I've written about Allergan's off-label migraine shenanigans previously. See Allergan's "Eye-popping" Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from "imploding" or "eye-popping" headaches but NOT "exploding" headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won't get into that -- you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan's physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see "Transparency Vs. Translucency in Reporting Physician Payments").

Will 250,000 Morbidly Obese People Sign Allergan's Petition to Congress?

"Be heard!", says Allergan. "The voices of 250,000 can influence the dialogue on the obesity epidemic and help shape policies that can make a real difference in our efforts to reduce the obesity epidemic."

That's the pitch of Allergan's new "social media" "C.H.O.I.C.E." ("Choosing Health over Obesity Inspiring Change through Empowerment") campaign, a core element of which is a petition to Congress to propose "legislation for obesity treatment and weight-loss surgery options like adjustable gastric banding for the morbidly obese."

The petition is really an ad for weight-loss surgery. It states:

"Weight-loss surgery has been proven more effective than diet and exercise alone in people 100 pounds or more overweight – and it's the only treatment proven to be effective long-term ... With less invasive procedures available (like gastric banding), weight-loss surgery has the potential to be a catalyst for change in the health of our citizens and the financial stability of our healthcare system."

Allergan doesn't have to include fair balance in the petition, because it doesn't mention its particular brand of "gastric banding" (ie, LAP-BAND).

This "social media" campaign includes a Facebook page and a Twitter account (@choicecampaign). I joined the "cause" on Facebook and am now following @choicecampaign.

LAP-BAND patients can also enter a contest by submitting videos to the Voice My C.H.O.I.C.E. contest program. Winners will get an all-expenses-paid trip to Washington, DC to be rolled out in front of cameras lobbying Congress for " increased attention" to surgery. Since contestants must already have had the procedure performed, I assume they will be "showcases" for how effective the surgery is.

Allergan's stated goal is to get 250,000 morbidly obese people (defined as being 100 or more pounds overweight) to "sign" its petition. Although I do not qualify as one of the "estimated" 15 million people in the US who are morbidly obese, I signed the petition and checked off the following options:

• Yes. I would like to receive future email communications from Allergan about the C.H.O.I.C.E. Campaign and the LAP-BAND® System.
• Yes, Allergan may contact me by mail regarding news and information about the C.H.O.I.C.E. Campaign and the LAP-BAND® System.
• Yes, Allergan may contact me by phone regarding news and information about the C.H.O.I.C.E. Campaign and the LAP-BAND® System.

This record of my CHOICEs will remind me that I specifically said it was OK for Allergan to call me by phone, which I hope it does. I recall the time another pharma company called me by phone and invited me to participate in a focus group of one about erectile dysfunction, another condition affecting millions of Americans (see "My Sojourn as Market Research Subject for Levitra").

If Allergan calls me and invites me to another focus group -- maybe held at its headquarters in Irvine, California -- I will demur and say I am too overweight to leave my house let alone fit in an airplane coach seat. If they offer first-class, all expenses paid travel, I will have to reconsider. I suppose I could rent a "fat suit" and fool them.

But, seriously Allergan, do you really think you can get 250,000 morbidly obese people to sign your petition? First of all, what's in it for them? Obviously, it's a benefit to Allergan. The petition only asks that Congress pay "increased attention" to the surgery solution. I guess that means money given to somebody because that's what Congress does. Is Allergan suggesting that Congress give obese people "fat vouchers" redeemable to cover certain costs of the surgery. I understand a lot of insurance companies may be reluctant to cover the costs of surgery. Is Allergan interested in getting Congress to force more insurance companies to offer coverage?

Despite the benefits to morbidly obese patients of signing the petition, I doubt that Allergan will motivate 250,000 of them to sign like I did. While 250,000 represents only 1.6% of the "estimated" 15 million morbidly obese people in the US, the C.H.O.I.C.E. campaign is not likely to reach that entire audience. If it were to reach 50% of that audience, 250,000 signatures would be a 3.2% response rate -- which is pretty high for such a campaign.

Many experts are wondering how to measure the effectiveness of social media campaigns like this one. What's the ROI? In this case, the effectiveness can easily be measured by how close Allergan gets to its 250,000 goal. I am not sure what timeframe Allergan has set to achieve that goal, but I hope they issue periodic reports telling me how many people have signed (remember, Allergan, you can call me).

NOTE: Another social media campaign with a publicly disclosed goal is BI's DRIVE4COPD campaign, which has a goal of reaching 1 million to take their "screener" questionnaire. So far, after 2 or 3 months, it looks like BI has reached only 76,109 people (ie, only 7.6% of their goal). BI "estimates" that "24 million Americans may have COPD. About half of those have not been diagnosed." So, a goal to reach 1 million out of 12 million (8% response rate) is even more ambitious than Allergan's "social media" ROI (a 3.2% response rate).