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POLICY: First Healthcare Reform Competition

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As those of you who’ve been deep in this post know, Eric Novack has been looking for answers to the healthcare reform debate and he suggested that we have a competition among THCB readers to come up with a decent proposal. So here it is, and you’ll see that it focuses on the sectors of the health care system that Eric and I think are problematic.  Answers in the comments section to this post please, and look for the lcuky winner to be on the radio with Eric soon.

Background: How would you change the healthcare system? What would you be trying to achieve? Here is YOUR chance to have others see YOUR ideas!

Rules:

1. 250 words or less (i.e. 10-15 lines)

2. MUST address the following groups and areas

a. Group 1: 70% of the population that accounts for only 30% of all healthcare costs

 i. 210 million people spend $600 billion

b. Group 2: 30% of the population that accounts for 70% of all healthcare costs

 i. 90 million people spend $1.4 trillion

c. Group 3: 15% of all medicare dollars are spent in the final 3 months of life

 i. $50 billion

d. How would you change, if at all, the current tax laws that exclude the cost of healthcare for businesses but do not allow for the deduction of health insurance premiums for individuals?

 i. The value of the tax exclusion is $200 billion

3. Must be very specific

a. For example, just saying that the government should buy prescription drugs to lower costs is not good enough

Winner:

1. Winner will be chosen by a combination of votes from readers of the blog and judging from Matthew Holt and Eric Novack

Prize: 

1. The adulation of your peers

2. The opportunity to explain your plan to the public on The Eric Novack Show, a weekly radio program dedicated to healthcare policy and politics

CODA: I will delete comments that exceed 250 words or are not exactly on topic.  I’ll put up an open thread for those above.

PHARMA: Jim Edward’s on big Pharma’s need to communicate about risks

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Brandweek’s Jim Edwards has a very sensible opinion piece (i.e. one I agree with) suggesting that big Pharma needs to start treating consumers like adults and tell them about the risks as well as the benefits of their products. I’ve always said that it’s in the the best long term interest of pharma companies and patients that the best understanding about their products is out there clearly.  And it’s apparent from  some of the research discussed by James Gardner on TCHB and over on John Mack’s Pharma Marketing Blog last week that the way risks are described in current product advertising has been glossed over using some quite clever psychological techniques.

But the overall concept that all drugs have effects, mostly good effects on bad conditions, but some bad for some people, needs to be reintroduced, so that patients and doctors can make up their own minds. Otherwise I think the end result will be a nanny-state hamstringing the pharma companies even more, to the chagrin of my libertarian friends. Whether big Pharma will adopt this pose remains open to question, even if the signs have been slightly more encouraging in the last few months.

POLICY: Wal-Mart Seeks Unbiased Research — and Gets It

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OK. This is a little bizarre. Wal-Mart is setting up a political war-room now that its opponents have a new documentary to rally around which captures several of its former managers on film discussing how criminal acts (albeit minor ones) were a part of its everyday management philosophy. Of course its impact on the health care system has been much discussed here on THCB, with the prevailing note being that despite the problems in employer based health care not being of its own making, Wal-Mart has never used its political influence to push for an improvement in the system, and has just dumped its lower paid workers onto Medicaid.

Now it’s sponsored an independent series of studies about its impact and some of the results are not too surprisingly not favorable. Of course, this might be the hubris you’d expect from the Bentonville Kool-aid drinkers who really believe that they are helping America, just like the people at Enron did. There is more to it than that and they’ve got some numbers to allegedly show that low prices justify lower wages–although I don’t think that the hi-tech industry works like that and prices there lower much more rapidly.

But the most interesting number quoted is that "states on average spent $898 for each Wal-Mart worker in Medicaid expenses." According to Reuters Wal-Mart has 1.7 m employees and in the NY Times article last month said it had 1.33m in the US. So if (and I may be mis-reading this) the 1.33m cost an average $900 each, that’s $1.2 billion just to subsidize Wal-Mart employees for Medicaid alone. Not exactly a huge share of the Medicaid budget, but not a negligible share of the Medicaid budget for acute care.

The average child in Medicaid costs $1,700 a year, while the average adult costs $1,900, and there are roughly 25 million kids and 12 million adults on Medicaid. So their care works out to $42bn + $23 bn = $65bn. So some 1.5% of that goes on Wal-Mart employees. That’s not nothing, given that a) they could easily afford it, and b) Wal-Mart’s presence pushes its competitors to force more of their employees onto Medi-caid or into uninsurance too.

So while Wal-Mart is pushing American retailers into looking more like it, it’s also slowly helping focus the nation on the issue of how to reform a health insurance system that was designed for a GM 1950’s world.

INTERNATIONAL/POLICY: Sick patients in six countries

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No reader of THCB will be surprised that the cross-national series which the Commonwealth Fund has sponsored for several years now (and for which my old colleague and friend at Harris, Kinga Zapert has been running the surveys) continues to find that sick people here have it worse than sick people in other countries. Their latest work was published in Health Affairs yesterday and it’s called Taking The Pulse Of Health Care Systems: Experiences Of Patients With Health Problems In Six Countries. Here’s the press release if you don’t want to read the whole thing.

The headlines have been taken by the finding that patients in the US were more likely to say that they’d experienced a medical error (34% here versus between 30% and 22% elsewhere). But no one really has got the medical error situation under control, and it’s likely that patient reporting isn’t such a great measure of medical errors in reality. After all, Brent James has shown us that clinician reporting is a lousy guide to whether mistakes have been made. And in general all countries need to do better on care management of sick people, including treatment planning and clinician co-ordination.

But of course the study continues to find the the US is a real outlier when it comes to the financial impact on patients of being sick.

• Half of U.S. adults reported that they had gone without care because of costs in the past year• In contrast, just thirteen percent of U.K. adults reported not getting needed care because of cost• One-third of U.S. patients reported out-of-pocket expenses greater than $1,000 in the past year• U.K. patients were the most protected from high cost burdens, with two-thirds having no out-of-pocket expenses. The variations were notable given the study’s design focus on sicker adults with recent intensive use of medical care. (My emphasis)

And while we continue to hear reams of rubbish about the terrible impacts of waiting lists in Canada, none of the America-first crowd in Health Care seem too bothered by the confirmation that speedy access to primary care is none too good here, and ends up increasing emergency room use.

Access—including after-hours access—and waiting times to see a doctor when sick differed markedly across the countries:• Canadian and U.S. adults who needed medical care were the least likely to report fast access (same day) to doctors (30 percent or fewer of U.S. or Canadian patients) (My emphasis)• In contrast, majorities of patients in New Zealand (58 percent) and Germany (56 percent) reported that they were able to get same-day appointments, as did nearly half of patients in Australia (49 percent) and the United Kingdom (45 percent)• Majorities of patients in Germany (72 percent), New Zealand (70 percent), and the United Kingdom (57 percent) also reported easy after-hours (nights, weekends, or holidays) access to a doctor• In contrast, majorities of patients in the United States (60 percent), Australia (58 percent), and Canada (53 percent) said that it was very or somewhat difficult to get after-hours care• The four countries with comparatively more rapid access to physicians—Australia, Germany, New Zealand, and the United Kingdom—also had lower rates of emergency room use, with Germany having the lowest rates• One-fifth of Canadians and one-fourth of U.S. patients who reported going to the ER said that it was for a condition that could have been treated by their regular doctor if available. (My emphasis)

I know this is just piling on, but for the gazillionth time let me remind you that the biggest difference between the US and the rest of these countries is that they cover their entire populations and do it for remarkably less per head than we do. And in virtually no other country are people financially destroyed just because they are sick.

There’s an awful lot wrong with health care everywhere, but my guess is that if there’s one reason that foreigners are saying Vive La Difference, it’s that one.

The authors, though, find a few other ways to put the boot in:

In past patient surveys among the five English-speaking countries, the United States has stood out for having relatively short waiting times for specialized care. Based on patients’ reports in this study, Germany also provides rapid access to such care. Understanding how Germany has achieved access to physicians, after-hours care, and specialized care while spending much less than the United States spends as a percentage of national income could help inform U.S. policy.Symptoms of inadequate insurance coverage and more fragmented care in the United States emerged throughout the survey. The United States outspends the other countries, spending 14.6 percent of national income compared with Germany’s 10.9 percent, Canada’s 9.6 percent, Australia’s 9.1 percent, New Zealand’s 8.5 percent, and the United Kingdom’s 7.7 percent.Yet the United States often ranks last or tied for last for safety, efficiency, and access. With one-third of U.S. patients reporting medical, medication, or lab errors and a similar share citing duplicate tests or medical record delays, our findings indicate widespread performance deficiencies that put patients at risk and undermine care. Moreover, a recent study finds that the United States is not systematically a leader in clinical outcomes.Confirming spending data from the Organization for Economic Cooperation and Development (OECD), the United States also stands out for its patient cost burdens, with consequences for access.U.S. physician visit rates are already low by OECD standards.To the extent that U.S. insurance continues to move toward higher front-end patient deductibles, these rates could go up, as increasing numbers of insured patients become “underinsured,” lacking access or adequate financial protection.Contrasts between the United States and Germany, in particular, indicate that it is possible to organize care and insurance to achieve timely access without queues, while ensuring that care is affordable at the point of service. There are clear opportunities for the United States to learn from other countries’ insurance systems.

PHARMA: More from James Gardner on the DTC hearings

Here’s more from James Gardner of One to One Interactive  on the FDA Hearings on DTC Advertising.

Welcome back for the second of two postings I’ll be making about the FDA’s public hearings on direct-to-consumer (DTC) promotion of regulated medical products. Today I have some observations about the presentation by Pat Kelly, President of Pfizer’s US Pharmaceutical’s group and a few other speakers. I’ll also share my own presentation and invite comments about its point of view.

Patrick Kelly, President Pfizer US Pharmaceuticals

Pat_kellyPat Kelly made a spirited, if formulaic, defense of DTC pharmaceutical promotion. I give him credit for making the effort to spend the morning at the hearings and can only speculate about what was more important for Kelly’s peers at Novartis, Astra Zeneca, and elsewhere. Shame on them for not making this a priority! Touching briefly on the free speech implications of restricting advertising, Kelly focused more on the very real public health problem of undiagnosed and untreated condition sufferers. It’s a powerful argument, but one where Pfizer and others may have undercut themselves of late with their overzealous use of promotional, not educational, messaging. Viagra’s NASCAR sponsorship is, after all, hard to defend from an educational perspective!

With the key message of “We can do better:, Kelly definitely scored points when he pointed out Pfizer’s voluntary compliance with the PhRMA guidelines and, more recently, its stated intention to exceed them in many cases. They’ve apparently earmarked a media budget equivalent to a “major brand” for condition-oriented health education initiatives. They’ll also be strictly limiting some of their DTC promotional efforts in the first 6 month after a drug’s launch and avoiding so-called “reminder ads”. Details were skimpy so it will be interesting to see how they bring these promises to life.

Importantly, the FDA’s line of questioning to Kelly focused on the theme of better communicating risk-related information to consumers. The FDA apparently feels that the overly effective communication of product benefits (real and implied) has come at the expense of the communication of corresponding risks.

It’s a fair perspective to hold, I’d say, so I was surprised to see Kelly wobble on his answers. Concerns about the communication of safety information in the context of a 30 or 60 second television commercial are not new. So, at last, some hard questions are being asked about the content, format, and literacy level of package inserts, safety warnings, and the like. I would expect to see these all reinvented through this process with an aim to making them more effective communication tools. Amongst many changes, look for a simpler literacy level (perhaps as low as grade 6), the removal of extraneous information (“less may be more”, commented one of the FDA panelists), and guidelines about font and font size.

(Even the visual layout of ads was called into question later in the day. The subject of debate: Can an image of a smiling and somewhat youngish-looking woman kneeling to tie her grandson’s shoelace somehow be construed as over-promising the effectiveness of a drug like Vioxx? How does that change if she’s not kneeling? How about not smiling? Can subjective impressions like this even be measured, let alone regulated?)

Kelly was promptly mobbed after his presentation. Most of the questions to him focused on his reaction to Astra Zeneca’s announcement that they’ll be advocating for a mandatory process of FDA/DDMAC pre-approval of all DTC promotional materials. Knowing that the FDA is woefully understaffed for this type of effort, it’s a “can’t lose” offer on Astra Zeneca’s part! However, it’ll play well in the popular press so my sense is that it was a smart move on their part. Kelly was non-committal on Pfizer’s response.

Abby Metha, Gallup and Robinson

Metha presented some interesting research about the effectiveness of DTC print advertising with and without celebrities. The use (and potential abuse) of celebrities is a known FDA concern so her research was quite well received.

The bottom line, at least as far as I could tell, is that celebrities can be effective as a “magnet” to draw initial attention to an ad, but they’re not necessarily effective at communicating critical messages. Specific to the FDA’s concerns, they’re also not necessarily more at creating an expectation of increased efficacy. The research was fascinating so I’d hope that Metha will post if for further discussion and review.

Michele Spence, PhD, manager, pharmacy outcomes at Kaiser Permanente

Spence shared a sobering study about the impact of DTC promotion on Kaiser Permanente’s efforts to control the cost of COX-2 inhibitors (e.g. Vioxx, Celebrex, Bextra).   

According to her press release:

“In 2001, researchers from Kaiser Permanente and UCLA surveyed 3,000 Kaiser Permanente patients. The patients were first asked if they had seen ads for the COX-2 inhibitor drugs, Celebrex or Vioxx. Patients who had seen the ads were then asked whether they had asked their physicians about the drugs. Prescription data was then analyzed to see if the patients actually were prescribed the COX-2 inhibitor drugs, whether the prescription was consistent with clinical protocols which called for reserving COX-2 inhibitors for patients at increased risk of gastrointestinal bleeding. This is the primary group thought to obtain benefit of the drugs compared to older non-steroidal anti-inflammatory drugs (NSAIDS). Results of the analysis show patients not at increased risk of gastrointestinal bleeding who saw the ads and asked their physician about the advertised drugs were 4 times more likely to be prescribed a COX-2 inhibitor than similar patients who did not see the ads.”

Importantly, as one of the FDA panelists pointed out, the increased likelihood of COX-2 inhibitors being prescribed may or may not represent an actual clinical problem since wedon’t know the factors that were part of the physician’s decision-making process. Spence  acknowledged that point and stressed that her conclusions focused more on the cost containment challenges faced by third-party payors.On the bright side, Spence’s research also showed a small benefit associated with DTC promotion of COX-2 inhibitor products. By causing an overall increase in the likelihood of COX-2 inhibitors being prescribed, DTC promotion also increased its usage amongst appropriate patients, i.e. those actually at increased risk of GI bleeding. If you or a loved one were in that admittedly smaller population of patients who benefited from DTC advertising, you might have a different perspective.

There’s more information about her research here:

Lisa Van Syckel, DrugAwareness.org

Van Syckel shocked the room into silence with a devastatingly emotional set of video clips related to anti-depressant medications and their now widely-known link to teen suicides. She related a tragic story about the alleged role that antidepressants played in her daughter’s repeated suicide attempts and called for the FDA to take action before more are hurt. Gripping testimony!

For those wanting to learn more, start at Van Syckel’s website:My own presentation to the panel focused on the role that the Internet does – and should – play in direct-to-consumer pharmaceutical marketing. Specifically, I shared some data about its usage by American health information seekers, presented a few best practice examples of its usage as an education and compliance tool, and called for the FDA to consider the channel’s unique qualities before imposing blanket cross-channel rules. If you’re curious, please download it here. Feedback would be welcome either here or to me directly.

Thanks again to Matthew for the opportunity to share my observations about these important FDA hearings. I wasn’t able to participate on day 2 of the hearings but would strong suggest you follow John Mack’s weblog as he continues to follow the sessions and related fallout.

POLICY: Single payer advocate debate wing-nut

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So in the Fresno Bee  a single payer advocate has a sensible piece on why California should adopt single payer. I don’t agree — I think we should have a multiple-payer system, with lots of single-payer look alike provisions, but at least it’s a sensible argument.

Opposing this view, the Bee has a piece from a complete nutjob. He seems to believe that there’s something terribly wrong with the US Mail (when there isn’t) and that all our health care problems can be solved by sending all illegal immigrants home. Yup he really has that as his number one solution. Who exactly will harvest the fruit & crops that supply Fresno and the central valley with all its income is not explained.

But the most interesting thing is the wingnut’s name.  It’s "Michael Der Manouel Jr".  Is there any possible slight chance that someone with the name "Der Manouel" is not either an American Indian or straight off the Mayflower?  If so, does he have proof that his family are legal immigrants? Sure sounds like a wetback to me. Perhaps sending him back "home" (along with the rest of his "conservative" brethren) might just be the solution to the health care crisis.

POLICY/BLOGS: More slack crap from Medpundit exposes the big conservative morality lie

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Late last month the NY Times had a pretty horrendous article about a family that was losing its house because it couldn’t pay for all the co-pays and co-insurance for its sick son’s care. I’ve just got round to catching up on my reading and I’m pretty shocked. You might think that someone who’d taken the Hippocratic oath might decide not to pile in on this, but you’d have mistaken the ever blackening stone that Syd at Medpundit seems to have in place of a heart these days.

She decides that the problem is that the family ran up credit card debt. And one of her readers jumps in to!

Sounds like the real problem here might be the credit cards.I get one or two notices of bankruptcy a year concerning my patients. They always list the debt that is to be forgiven along with the creditors, and it’s overwhelmingly credit card debt – the major cards and the local retailers that have their own credit cards. That’s probably true for the general population as well – which is why the Times couldn’t find a better example of people with health insurance going broke because of medical expenses alone. UPDATE: A reader does the math: The $5,000 a year quoted comes out to: $416.67 a month, $13.69 a day, 7% of the household’s income. One mistake people do make in managing their financial affairs is that they fail to readjust their living standards downward to account for unexpected regular expenses (e.g., sell the house and car and downgrade).Or are we so rich now that the idea is that not only should an illness not bankrupt but that you shouldn’t have to skip trips to the mall?

The only problem is that Syd and her reader failed to read the bloody article! Here’s what it said and it is quickly apparent that the expenses connected to the kid’s illness massively exceed their max-out of pocket and the $5000 number, almost certainly because many of these expenses are somehow excluded from their insurance coverage.

Then the bills started coming in. After a week in the hospital, the couple’s share came to $1,100 – not catastrophic, but more than their small savings. They enrolled in a 90-day payment plan with the hospital and struggled to make the monthly installments of nearly $400, hoping that they did not hit any other expenses.

But Zachery, who was eventually found to have an immune system disorder, kept getting sick, and the expense of his treatment – fees for tests, hospitalizations, medicine – kept mounting, eventually costing the family $12,000 to $20,000 a year.

So the cost is not the $5,000 a year. That’s just the co-pay on ONE of his drugs. The rest is between $12 and $20K a year, and the poor bloody father is out working 90 hours a week to make just 68K a year (which for those of you counting at home is under $30K for a regular working week). So somewhere between 17% and 30% of the family’s PRE-tax income was going to these costs. That’s way more than any young family is going to have to spare, unless perhaps they have a high-earning physician bringing home the bacon. So either the Times didn’t do any fact checking (and God knows they have a sorry legacy on checking them when it helps conservative loonies and their issues), or this family was financially destroyed by medical bills despite having some insurance coverage. And "some" is the appropriate word here:

As the family went from one doctor to the next, without a diagnosis of the root problem, the insurance company often questioned the expenses. Why did Zachery need four doctor visits or five rounds of antibiotics for an ailment that most children shook off in a couple of days? Mrs. Dorsett spent days on the phone, often in voice-mail loops, and often long-distance, pleading her case.

"Like when they refused to pay for antibiotics when he had pneumonia" last year, she said. "The antibiotics cost $373, and we didn’t have it. But we couldn’t just not give it to him. I knew the review board would come around eventually, but he needed the medicine right away. Finally the doctor gave us samples."

She managed the expenses, like many people, by constantly applying for new credit cards, rolling the debt from the old cards into the new ones, which usually came with low introductory interest rates. In a good year, they would have the rolling charges on their credit cards down to $5,000 or $6,000, but the charges always went up again.

And how does Syd’s reader really think they should do it?  Their solution: Stop going to the Mall! Of course Syd’s "reader" didn’t get to page two where it showed that they family buys its clothes at yard sales. And don’t bother bringing your plastic into Syd’s office for your co-pay. Syd apparently doesn’t know that you can use credit cards to pay medical bills, and that they charge outrageous interest rates, and that that is likely to be where the debt came from.

"Not only are the bills higher, but the way we pay for care has changed," said Elizabeth Warren, a professor at Harvard Law School and one of the study’s authors. "My mother always carried a bill with the doctor, but every dollar she paid went to principal. Today, the doctor takes a credit card, and a family might be paying that off at extraordinary interest rates. So people may recover physically from major medical injury, but may not recover financially."

So yup we have a nation of over spenders, but I don;t think this family fits the pattern. But the bullshit morality aimed at people with medical problems like this by our conservative brethren is just astounding. And I remind you that this does not go on to anything like this extent in other industrialized countries because they have come to the reasonable position that being sick should not be a financial death sentence.

POLICY: A tax proposal for fairness, but it’ll never make it, WITH UPDATE

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Finally a tax proposal I approve of (even though it would hurt me personally). There’s a commission that wants to lower the limit on mortgage tax deductions.  But of course every elected official in California and New York is freaking out about it.

There has to be a way that this iniquitous tax break (and the one on health benefits) can be removed fairly so that those with the highest incomes don’t get most of the benefit. My proposal would be

1) Abolish all tax relief on second homes (currently you can get a deduction for mortgage payments on a second home with a mortgage of up to $1million)

2) Limit the deduction immediately to the interest on a mortgage that’s equivalent to the median house price in the CSMA (large metro area), so that the number would be bigger in San Francisco and New York, and smaller in Kansas, but then reduce that amount by 5% each year, phasing this out over 15-20 years. (Rather than gong straight to a "modest" house price and sticking with that ongoing)

That would immediately take away the advantage for the high income earners and restore some sanity to the housing market, as well as encouraging people to pay down their mortgages rather than borrow more against their homes for yet more consumer spending.  But it wouldn’t be such a radical move that it would kill the housing market overnight and send us into a recession.

But the panel has come out with average costs that clearly ignore the realities on the ground in more expensive states — The new cap would be linked to Federal Housing Administration mortgage limits set county by county each year based on the cost of a "modest” home. Those limits range from $172,632 in low-cost states to $312,895 in the most expensive counties, such as Santa Clara. Around here the median house price is closer to $750,000.

The trick is getting this number to stall so that housing becomes more affordable, the tax iniquity is not just reduced but eliminated altogether, but that it’s one in a way that doesn’t penalize people in more expensive states and wreck the whole plan.

Still it’s amazing to see that this Administration has anything to do with a plan which doesn’t give extra benefits to the very rich.

And of course health benefit tax deductibility is next, as this Managed Care magazine article discusses. Note the extremely sensible comments from Alain Enthoven and Uwe Reinhardt at the end of the article.

UPDATE–An interesting wrinkle suggested by Uwe. If employers had to put the amount they spend on health insurance on the employees’ W2 would they put the average they spend, or what they actually spend per employee?  Anyone who’s bought health insurance knows that a typical small company is quoted the amount per employee, so a 50 yr old person with a family costs a whole lot more than a 20-something single. Of course most employees don’t realize that. But to take this to its logical extreme for self-insured companies,  "premium" costs per se don’t exist. Instead costs are exactly equal to the actual costs of care for each employee. So should their employees see the total amount spent on their care, and then be taxed on that?  If you have a $100,000 hospital stay, should you pay tax on that money? More interesting conundrums to be worked out here too.

PHARMA: What next for DTC regulation? by James Gardner

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Those of you following along at home know that big Pharma is trying to get ahead of a suddenly hostile Congress (including Bill Frist turning on them) on the subject of DTC advertising. This week they’re holding hearings on direct-to-consumer promotion of regulated medical products. Joining us from Washington DC as a guest blogger, James Gardner of One to One Interactive shares his observations on today’s hearings. James is an authority on Internet marketing and how the channel should most effectively be used by pharmaceutical and device marketers. As well as sharing his observations, he’ll also be addressing the panel and advocating for the interactive channel to be regulated differently than traditional TV, radio, and print. His agency’s past and current clients include GlaxoSmithKline, Pfizer, Roche, Boston Scientific, Schering/Berlex, and Digene.

Hello, welcome, and a big “thank you” to Matthew for allowing me to share my observations from today’s FDA hearings on direct-to-consumer (DTC) promotion of regulated pharmaceuticals and medical devices. I’m in Washington for the day to address the hearings with a point-of-view on the internet’s role in DTC promotion, but I’m excited to also provide some color commentary.

As some of you surely know, the FDA announced its intention in mid-September to hold a series of public meetings on a range of issues related to DTC marketing. The FDA’s goal, quite clearly, is to develop a new regulatory paradigm for pharmaceutical and device marketers. While the FDA has been down this path before, the political and business environment today seems more conducive than ever to having real change actually happen. In that sense, these hearings could be an important regulatory milestone.

My personal expectation, shared by many (but not all), is that we’ll see several things emerge from this process:

  • Blanket restrictions on several currently popular promotional tactics
  • Significantly clearer guidelines articulated about still-permissible tactics, and
  • Much stiffer consequences for those failing to comply with the letter and spirit of the new rules.

I don’t see an outright ban on DTC promotions happening, although some will certainly advocate for that approach. Indeed, with the DTC promotion envelope continually and aggressively being pushed by adventurous marketers, one could plausibly argue that wholesale change is both inevitable and desirable.

That said, I think cooler heads will prevail and the FDA will choose a path of lesser resistance by instead adopting many of the voluntary guidelines articulated this summer by PhRMA, the industry’s trade group. Most of their proposals were quite sensible and all would serve as a good starting point for the FDA to regain control of the DTC promotion agenda, if nothing else. A pragmatist always, I see some positive change as being better than no change at all.

For those of you new to the world of FDA hearings, here’s what you’re missing:

Clip_image002

There’s a large podium across the front where the first group of FDA panel members are sitting. Below them, on the audience’s left, are additional panel members. Also below them, but to the audience’s right, sit the 3-4 speakers in each “wave” awaiting their turn to address the group. Speakers use a podium on the audience’s right, projecting slides on two very large television screens. If you look closely, you’ll also see that we’re using the National Transportation and Safety Board’s auditorium – hence, their “shield” on the wall behind the podium.

Speakers have 12 minutes to make their case. When their time ends, the moderator thanks them graciously for participating and helps field questions from his colleagues and, time permitting, the audience. Questions from the FDA panel to speakers are obviously allowed, but questions to the panel in return are generally frowned upon.

Kudos to the FDA — it’s all quite well organized. We’re keeping to the agenda and making good progress.

Tomorrow: Thoughts and reactions to Patrick Kelly from Pfizer and speakers from the ASHP, AARP, and other organizations. I’ll also post my presentation with the hope of stimulating some discussion!