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

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

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.

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

"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").