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How PhRMA’s Marketing Code Sells Itself

When it comes to marketing, packaging counts.

That also seems to be the case with marketing guidelines--at least, with the revised Code on Interactions with Healthcare Professionals from the Pharmaceutical Research and Manufacturers of America.

We've written a lot already about what the substantive changes to the code itself means, including its compliance mechanism, and new limits on pens, meals, speakers and CME. We’ve even offered three easy steps companies can take next to achieve a utopian future.

But beyond the message PhRMA is sending though the content of the code, there’s the image the association is projecting through the formatting of document itself. The precepts in the revised code are basically a progression from the 2002 code, but the layout is stunningly different.
The most obvious change to the code’s formatting is the color palette and design motifs. The blocks of black and red had been replaced by blues and grays in spiral patterns. What do those changes mean?

Well, we asked some of our designers their opinions. Overall, the design of the 2002 code is “forceful” and intense, they tell us, while the 2008 code is relaxed, though still “peppy.”

The new document also tones down PhRMA’s self branding. In the old version, the association’s acronym was the biggest thing on the cover page, and it towered over every question in the Q&A section. In contrast, the PhRMA logo only appears three times in the new version. Those changes may reflect an industry that now feels its size and strength make it a target for criticism. Blue is also a “loyalty color,” we are told, and the new code may in fact be bathed in Patone’s “Dispense As Written Azul.” The 2008 version also boasts a table of contents – how’s that for transparency?

Another formatting change may be evidence of industry belt tightening. Even though it contains more words, the page count of the 2008 code is 36 pages, while the old one weighed in at 58. Like marketing departments everywhere, it’s doing more with less.

Despite the reduced page count, the text in the revised version is larger and more readable than the previous version, but it uses a sans-serif font. While clean and easy to look at, a sans-serif font (like Helvetica) does not fit with the eye the way a serif font (like Times) does. According to the experts, when reading large amounts of text, people are better able to absorb it if it comes with the complex features at the tops and bottoms of the character strokes.

If that’s not an endorsement of industry’s shift towards biotech products, we don’t know what is.

– M. Nielsen Hobbs

Next Steps for PhRMA and Marketing (Part 3): Let the Sunshine In

Concluding our series of proposals for pharmaceutical marketing to reclaim the high ground. We've already suggested re-defining the mission and combining the Pharmaceutical Research & Manufacturers of America's various codes of conduct.

Today, step three: Let the Sunshine In

“Transparency” is now everybody’s favorite buzzword in Big Pharma. Merck CEO Richard Clark urged his colleagues to embrace the call to "create transparency" during his inaugural address as chairman of PhRMA.

Indeed, the immediate impetus for PhRMA’s effort to update the marketing code came when Congress got serious about pushing “sunshine” legislation. (And the Code is already a success, since that initiative did not make it into law this year.)

The problem with transparency: by definition, you can’t see it. Obstruction you can see. Transparency is invisible.

Since the calls for transparency are motivated fundamentally by mistrust of industry, how will the public (or at least its elected representatives) ever be satisfied that industry is in fact being transparent? Put another way, if industry chooses to hold anything back—for competitive reasons or otherwise—why wouldn’t the assumption continue to be that some ugly truth is being hidden away?

Our suggestion: invite the public in to those conversations. Every pharma company should appoint a transparency committee, a group of independent outsiders--preferably well-known critics. The transparency committee (though we prefer the name "sunshine band") would have carte blanche to review anything and everything related to the company's procedures on information disclosure. They would be empowered to make recommendations that the company would be obliged to respond to. (Not necessarily implement--but at least acknowledge and explain a decision not to implement.)

The transparency committee should report directly to the board—or even better, to a central transparency committee convened by PhRMA. We even have the perfect chairman: Cleveland Clinic Cardiologist Steve Nissen. (He may have bigger plans for his career that rule him out, but still.)

Nissen is a particularly articulate critic of industry on issues like publication bias and clinical trial result reporting. But he is also a clinical investigator and an experienced author of academic research, so he understands the importance of protecting information as well.

That whole idea may sound crazy, but give us a second, we're just getting warmed up.

Industry could go yet one step further than letting its critics shape disclosure policies: it could ask them to review and approve its marketing plans in the first place. Now we know this sounds crazy. Pharma companies went ballistic over a provision in an early draft of the FDA Amendments Act that would have explicitly authorized FDA to review a company’s marketing plan in the context of assessing a proposed Risk Evaluation & Mitigation Strategy.

That provision came out--but the spirit lives on. In fact, we would argue that a suitably motivated FDA can and will demand access to marketing plans for drugs under the REMS authority. And even if FDA doesn't push that way on its own, the fact that Congress thought about it once means it is likely to come up again later.

More to the point: industry says marketing is about delivering valuable scientific information to doctors and patients. It is about education. So why not ask those being educated to review and respond to the curriculum? Who knows, they might even get excited about the new medicine...

Enough opining from us. What do you think?

Next Steps for PhRMA and Marketing (Part 2): Combine the Codes

Continuing our free advice for Big Pharma marketing groups on ways to reclaim the high ground. (And yes, you do get what you pay for...)

Yesterday, we suggested a new mission statement for marketing.

Today, step two: Combine the Codes

PhRMA has statements of principle governing professional promotion, direct-to-consumer advertising and clinical trial disclosure. But industry’s critics do not see them as separate issues. Neither should industry.

Let's start with the two "marketing" codes, one for DTC and one for interactions with physicians. It is easy to see why there are two: there are very real differences in the regulatory oversight of DTC and professional promotion, reflecting the fact that DTC is a "new" phenomenon (at least in the sense of broadcast television ads), while sales reps calling on doctors is a venerable industry institution.

But when it comes to defending marketing in the political realm, it is silly to try to differentiate. Indeed, association CEO Billy Tauzin acknowedges that many of the public perception issues facing the industry require addressing both DTC and professional promotion. So PhRMA is upgrading its principles of consumer advertising too.

In an era when informed patients often know more about their medical conditions than the physicians who treat them, it is also absurd to argue that there is a fundamental need to craft different messages based on who has the MD. (Different messages based on knowledge level yes, but sometimes that means dumbing it down for the docs and engaging more scientifically with patients.)

We might also highlight the danger for industry if doctors—not the biggest fans of DTC in the first place—begin to really get upset about it now that they spend more time in front of the TV and less time at industry sponsored dinners.

Updating the DTC code is a nice first step. But PhRMA and its members should go further. In age when Big Pharma is rethinking everything (or should be), it is time to challenge the mindset that professional marketing and consumer promotion are two different activities. A sales rep visit is indeed different than a TV commercial during the Super Bowl. But both are probably equally inefficient.

If industry wants to reclaim the high ground for marketing it must take a stand on who the marketing is supposed to benefit. The updated PhRMA code does that, by the way: "Our relationships with healthcare professionals are regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine."

If the goal is to benefit patients, then it is nonsensical to consider sales force activities and DTC as in any sense separate. If either the patient or the physician lacks the necessary information to make an informed therapeutic choice, then the marketing campaign failed.

The code of conduct for clinical trials is less obviously part of the same picture, but PhRMA would do well to look at it in that light. Industry bristles at claims that its big R&D budgets are really just to support marketing. But let’s face it: the questions asked and answered by clinical trials and other industry sponsored research are indeed the primary source of information about medicines—and so the very essence of all industry marketing.

Put another way: no one objects to industry sponsored research. They object to the perception that the results are skewed or hidden based on a commercial agenda. In other words, they think marketing trumps R&D.

PhRMA’s current clinical trial code covers issues related to reporting and disclosure, but Congress has already taken that issue much further. If PhRMA wants to reclaim the high ground, the association will need to take another look at that policy—especially in the context of even bigger steps to rebuild its reputation.

Tomorrow: Step Three—Let the Sunshine In

Next Steps for PhRMA and Marketing (Part 1): Define the Mission

Our hats are off to the Pharmaceutical Research & Manufacturers of America task force on professional practices. It is no simple matter to get three dozen companies to agree on anything—much less something as politically and commercially sensitive as the rules governing marketing to physicians.

And to do so in a way that addresses real-world, day-to-day operations is so much tougher. PhRMA’s updated Code on Interactions With Healthcare Professionals wrestles with the nitty gritty details of how physician marketing works, and doesn’t shy away from tough, specific directives on everything from pens to meals.

So no one can say PhRMA is hiding behind bland statements of principle rather than addressing the real world.

But perhaps you can say the opposite: that in getting into the weeds of how marketing works, PhRMA has lost site of some bigger principles. Debates over pizza and pens may help in that cause, but they don’t come close to justifying marketing as a vital, necessary activity for society.

In that spirit, may we suggest three modest proposals of our own?

Step One: Define the Mission

It is time (past time, perhaps) for PhRMA and its members to redefine the role of marketing and reclaim the high ground.

Every marketing organization should have a mission statement that it can embrace and brag about. The goal cannot be simply to increase sales. The goal should be to ensure the widest appropriate use of life-improving or life-extending medicines. Marketing done right means a medicine reaches more of the right people; it maximizes the benefit society receives from medical science.

PhRMA’s updated code on interactions with physicians suggests this mission in the preamble: “Appropriate marketing of medicines ensures that patients have access to the products they need and that the products are used correctly for maximum patient benefit.”

Hopefully, every marketing organization believes that already. The hard part is convincing the rest of the world to see it that way.

To do that, you can’t just say that’s what marketing is—you have to mean it. For example, do companies compensate marketing personnel based on “maximum patient benefit”? Its hard to say yes if sales reps get bonuses for boosting prescription market share in their territory: that is compensation based on maximizing revenue.

Of course, coming up with bonuses tied to maximizing appropriate use requires some real creativity, and probably a complete rethinking of the marketing effort.

But that’s only step one.

Tomorrow: Step Two--Combine the Codes

Who's Afraid of REMS Marketing Limitations?

Some coincidences can be very instructive and tell you a lot about the future.

RiskMAPs & black boxes don't necessarily spell doom

If Genentech’s current experience with its omalizumab (Xolair) allergic asthma therapy is any model, FDA's new risk minimization action plan (RiskMAP) authorities don’t look like necessarily a bad thing.

The safety issues facing the drug--an expensive therapy at the root of Genentech's recent acquisition of partner Tanox--were troubling, and resulted in a black box warning proposed in February by FDA and updated earlier this month.

Almost to the minute as the House of Representatives wrapped up its version of the FDA revitalization act (user fee reauthorization and drug safety reforms) last Wednesday evening, Genentech was explaining to a small group of financial analysts that one of the prominent, new regulatory powers being granted to FDA by Congress may actually be a boon to a threatened Genentech brand:

11 July, 6:00 PM at the Capitol: The House halts its truncated debate on the FDA Amendments (HR 2900), only one representative (New York Democrat Maurice Hinchey) speaks out against the well-managed bill. A final one-sided roll-call (403-16) passed the bill at 8:29 PM.

3:00 PM in South San Francisco: Genentech product development president Susan Desmond-Hellmann (right) tells a conference call on Genentech’s second quarter results that the company’s adoption of a new RiskMAP for Xolair will be a stabilizing event for the product and good for its continued growth. (Indeed the product's sales have been growing since the initial FDA warning anyway: Xolair sales were up 17% to $111 million in the first quarter when the safety alert was announced and up 14% in the second quarter to $120 million while Genentech and FDA were working out the specifics of the RiskMAP. The accepted plan was announced on July 2.)

Asked to comment on the commercial impact of the RiskMAP, Desmond-Hellmann characterized the company’s dealings with FDA and creation of a new safety program as a very positive effort. She said that the RiskMAP would help Genentech balance the needs of a very sick patient population with “a wish to protect them from adverse events.”

But RiskMAPs or REMS (as they are being called in the new legislation) have been signaled out by critics of the new legislation as one of the more threatening aspects of FDA’s new safety armentarium. An informal short-hand for describing the new authorities has already developed in pharma circles: the RiskMAPs allow FDA to “inform, nag and nudge, and impose limits.”

Not to Desmond-Hellmann or Genentech. Noting that many of the analysts might not be familiar with the procedures “because they are relatively new,” she portrayed the RiskMAP as a good way to work with FDA to supplement traditional labeling and provide more guidance to the medical community.

Both the Senate and House drug safety bills will make REMS more prominent by giving FDA more explicit authority to require extensive programs to alert doctors and patients to problems with new or already-marketed drugs. That authority includes requiring special messages to the medical community and patients, safety messages in ads, limited access restrictions, and follow-up surveys, registries and closer product surveillance.

Lets break down the elements of Xolair's RiskMAP:

Black Box Warning: The most onerous part of program is the box warning at the top of Xolair’s professional labeling.
Patient Medication Guide: Pateints are to be given a brochure starting with a direct mention of the analphylaxis risk before each injection.
Patient observation after injection: The RiskMAP stresses that physicians should keep patients in their offices for an adequate period of time after administration of the shot to watch for a reaction. FDA doesn't specify a waiting time but patients generally wait about two hours already, according to a 2005 study by Genentech's Xolair marketing partner Novartis.
Follow-up surveys: Genentech will follow-up with doctors administering the drug (mostly allergists and pulmonologists) and with patients to find out how the educational materials are working. In effect, the surveys just act to keep Genentech and Novartis more closely in front of the doctor and tied to the patient.
Two post-marketing studies: One will look for a skin test for use with Xolair to try to address the unpredictable nature of the side effect. This is an obvious step that the company would have likely undertaken on its own at the first sign of the increased rate of anaphylaxis. The second test is a version of closer product surveillance through an creation of an observational repository of cases of hypersensitivity reactions associated with Xolair and appropriate control cases. Again, this is a reasonable portective move to assure that the company will not be left at the mercy of FDA’s adverse event reports in the future.

Overall, the Xolair RiskMAP looks like a sound product protection plan that actually cements the company’s position with providers and assures that the product will be restricted to a very sick group of patients: a group which justifies the current high cost of the treatment. If FDA’s new authority makes more companies adopt plans like this, the industry could be headed into a period when postmarketing problems become resolvable and not the cause of sudden product withdrawals.

Get on the Brand Wagon

The new rules of drug safety mean that sponsors will have a lot to think about when they submit an NDA to the Food & Drug Administration. But while there’s a lot of new policy coming, companies shouldn’t overlook changes to the way they make one of their most basic decisions—what to call a newly approved product.

The brand name is a small part of the overall NDA. But it’s quite unsettling when FDA denies a sponsor its preferred option for a new drug name—sometimes wiping out years of brand name recognition. (Sanofi-Aventis’ obesity drug rimonabant—Zimulti, née Acomplia—is a good recent example.) And there’s always the odd case of a product that’s approved without an agreed-upon trade name—a disaster for any marketing department.

The Onion, of course, was way out in front of this

The process by which companies obtain FDA approval of a proprietary name has been pretty straightforward. Drug companies submit up to two names for review, and the agency tests for potential medication errors, as well as false and misleading claims. Sponsors can usually expect to hear back from FDA within 90 days of the user fee date—but there are always examples of reviews that take much longer.

But all that’s about to change.

Under a pilot program proposed in the Prescription Drug User Fee Act reauthorization package, the responsibility for testing brand names would shift from FDA to the drug sponsor. In exchange, FDA would commit to completing its review within a set time period. In essence, that would make the system more predictable for drug sponsors—albeit a bit more expensive. The RPM Report has covered this topic extensively; for more complete coverage, read this story and this story.

Want to learn more? The RPM Report is co-sponsoring an audio conference on this very topic with the Food & Drug Law Institute next week. Experts from FDA and industry will be on hand to answer all your questions about the changes to—and challenges of—getting a drug name vetted by the agency.

Our expert panel includes Debbie Henderson, FDA’s director of executive programs at the Center for Drug Evaluation & Research; Jerry Phillips, director of the Drug Safety Institute and the former head of FDA’s Division of Medication Errors & Technical Support; and Bob Lee, assistant general patent counsel at Eli Lilly.

The audio conference, “Naming Drugs: The Pharmaceutical Brand Name Challenge,” will be held on Wednesday, July 18 from 1 pm-2:30 pm. Registration information can be found on FDLI’s website at http://www.fdli.org/conf/413.

Can P&G Stomach the Risk Even When It's Reduced?

P&G Pharmaceuticals has been the Henny Youngman Rodney Dangerfield! of the drug industry: it couldn't get no respect. And so last year it remade itself, becoming what it calls a “search and development organization,” apparently on the model of Shire and Endo.

When it announced it was abandoning discovery, in February 2006, P&G was both admitting it couldn’t compete in research—and that it couldn’t stomach the risk. It laid off, or transferred, most of its researchers; it has spun off at least three research programs (more on that in another post); and now it’s got 45 people scouring the earth for licensable products in its chosen therapeutic areas: gastro-intestinal, musculo-skeletal and women’s health. Two key criteria: P&G only want drugs for patients that have “high involvement in their disease”; and they want products for which the development risk is “reduced.”

They’ve got some ambitious goals. To reach their growth targets, they want to launch one new product every 4-5 years – and that drug needs to become – echoing Jack Welch’s famous maxim for GE—number one or two in its category. To get to their launch target, P&G figures it will need to do 2-3 deals per year.

The question, however, is whether the kind of products that get to be #1 in their categories are also the kind of products that P&G management will be willing to pay for. It’s a challenge, admits Jeff Davis, who runs new business development. P&G has a shareholder base which demands 4-6% growth a year—that’s the kind of growth that justifies not reduced-risk research, but no-risk research, the sort that figures out how to get more or less pulp into orange juice or no-drip caps onto detergent bottles.

Moreover, while Big Pharma isn’t generally ponying up for reduced-risk development projects (in general, they still want NMEs), spec pharma is, and paying Big Pharma-sized upfronts. But P&G figures it can win these deals by emphasizing its consumer-focused marketing approach (it had an entire team of R&D, finance and marketing execs outfitted with an electronic system that, for a week, at all times of day, signaled them to react to the unpleasant gastrointestinal events of ulcerative colitis patients). And if—as this blogger believes--spec pharmas are going to be P&G’s biggest dealmaking competition, then P&G really will have an interesting advantage.

The pitch worked for Aryx Therapeutics, one of two companies with whom P&G has signed deals since its reorganization (the other is Nastech, for nasal-delivered parathyroid hormone). The Aryx drug, for GERD and gastroparesis, hit all the P&G criteria: a GI product (for GERD and gastroparesis) and risk-reduced (works like Propulsid but, apparently, avoids the drug-drug interactions which killed it). “We had three virtually identical term sheets,” says Aryx VP and COO John Varian but chose P&G because of their “focus on the consumer.”

Still, P&G is hardly burning up the dealmaking track. They’ve done two deals since their restructuring—the last in July 2006. Davis is confident that in ’07 his group will be able to get to terms sheets on 2-3 programs. There are plenty of biotechs who'll appreciate the P&G approach. But we wonder whether the Consumer King will tolerate the risk of signing them.