DoseofDigital: "Is the FDA Already Creating Digital Promotion Rules?"

Is the FDA Already Creating Digital Promotion Rules?

source: Dose of Digital blog (Jonathan Richman)

link to original: http://bit.ly/eJlk

[below is simply a re-post of Jonathan's great, thought-provoking blog)

Many people in and around the pharma industry have been asking for the FDA to create some more specific and updated guidelines for digital promotion. There have been a bunch of conferences where it’s been a hot topic and I’m sure there’s been a few focus groups, but one thing’s been lacking from these. The FDA. They’ve been pretty quiet. 

As it stands now, the FDA (actually DDMAC) regulatory guidance has been pretty thin regarding digital. I noted in a post a while back that the FDA recognizes 40 different types of promotion ranging from DTC TV to the archaic and oddly named “Professional House Organ.” All digital promotion is relegated to just one code “WWW” for  ”Internet Promotion.” There are about five different category types of print advertising for professionals, but there’s only one for everything possible in digital. I wonder where mobile fits in? Get your own 2253 submission form here and see for yourself.

So, I think we can all agree that the guidelines and oversight of digital promotion by the FDA are pretty weak. That doesn’t mean that they ignore digital promotion, as the folks from Shire found out when a YouTube video of theirs drew a warning letter. But, they haven’t spelled out what’s legal and what’s not, so everyone is left guessing just a bit. It appeared that Eye on FDA might have cracked this mystery a bit last week with their interview of an FDA official regarding the use of social media by pharma. Unfortunately, despite Eye on FDA’s best efforts, the FDA official was, not surprisingly, pretty vague and non-committal. The net was that there’s nothing inherently violative about social media, it’s the message that matters. In other words, just because your brand has a social media site doesn’t mean it’s in violation, but if the information and content on that social media platform  (e.g., off label, lacking fair balance) is in violation, then the entire thing is. No big surprise, as Shire can tell you. 

Today, MediaPost decided to get some attention by simply rehashing the Eye on FDA interview, but adding a more attention grabbing headline “FDA Official Tells Blogger That Pharma Social Media OK.” Technically, this was said, but it certainly wasn’t a green light for pharma companies to do whatever they want in social media. The MediaPost article has been all the rage on Twitter today, but I’m doubting many read the full details. This interview (and certainly MediaPost’s reworking) was far from providing any specific information on how pharma can use social media. MediaPost’s on my “list” today.

Okay, so no guidelines yet. How far are we from them? Great news! Not far. It appears that there’s already a workstream in place at FDA to develop new digital promotion guidelines. While poking around their site, I came across a section called “Policy Development and Guidance to Industry.” There’s a list of areas where FDA is developing new guidance. One of these is this:

“Promotion on the Internet.- As part of an FDA working group, DDMAC is developing an agency-wide policy to address how advertising and promotion of FDA-regulated products will be regulated on the Internet.”

Outstanding. Relax everyone, the FDA has it well in hand. Sure, we’d like a say in what they come up with, but aren’t some guidelines better than none? I can stop my open letter to the FDA and all the discussions with colleagues on what we’d like to see in the guidelines. It’s too late. They’re coming.

Or are they?

Being a bit of an FDA skeptic, I dug a little further. I noticed that there wasn’t a date on the page, so I couldn’t immediately tell when it was updated. Never fear. Enter the Internet Archive Wayback Machine. For those not familiar with this outstanding tool. You can enter any domain name and this archive will show you updates to the domain and allow you to view the page as it looked in the past. I did a search for this FDA policy page and here’s what I got back. 

Pic link: http://www.doseofdigital.com/wordpress/wp-content/uploads/2009/03/fda-wayback.jpg

As you can see, some version of this page dates back to 2000. So, I clicked the link to the earliest version of this policy page, which dates back to November 20, 2000. The results unfortunately weren’t surprising. There it was…the same exact statement for “Promotion on the Internet.”

“Promotion on the Internet- As part of an FDA working group, DDMAC is developing an agency-wide policy to address how advertising and promotion of FDA-regulated products will be regulated on the Internet.”

My hopes were dashed. 

Here’s what this tells me. The FDA’s been planning to deliver new guidelines for “Internet Promotion” for at least eight and a half years. Once more…eight and a half years. Take away message: Don’t hold your breath on new guidelines. 

Message two: Don’t stop doing new things in “Internet Promotion” because of this. Remember, as far as FDA is concerned, digital is a promotional channel like any other. The same rules apply to digital as they do to print and anything else. If you make claims, they’d better be on label and they’d better include fair balance. If you remember that one rule, you’ll stay out of trouble 95% of the time. 

We do still need to sort out some specifics around the use of social media. Is there ever a way that a brand could really open up live comments and discussion from patients on a branded site? Maybe. We lack the guidance about how this can be done successfully and in compliance though. However, the FDA is generally a fair bunch of folks. They don’t want to kill every idea of yours. They do want it to follow some rules and they will work with you to figure out a way you can do your idea and stay in compliance with the rules.  In other words, can I do this if I also agree to do that? For example, Fabio Gratton from Ignite Health came up with an idea that basically was a widget pharma companies could install on their social media sites that allowed patients to report adverse events in a single click. Perhaps if a company agreed to include this widget in a prominent, then FDA would allow live, unmoderated comments. Give a little, get a little.

For now, we don’t know, but that doesn’t mean we can’t forge ahead. The FDA will give comments on any idea before you launch it, so there’s no excuse to not try because you’re worried about trouble later. Get FDA involved early and you might be pleasantly surprised what’s possible. You won’t be the first try social media in pharma. Remember the Pharma and Healthcare Social Media Wiki we (including all of you) created? Well, share that with your company and show them that you wouldn’t be the first. Many others have tried and not one of these programs have gotten a single warning letter.

Why would you?

Federal Court Rules FDA Must Reconsider Plan B Decision

Ok, FDA, this is pathetic.   I am that last true believer that you will do the right thing -- so don't make me lose hope.  If politics and ideology are truly swaying how you make decisions, then I am extremely concerned about your relevance in the future.  However, I will say this:  until we have a direct conversation (instead of me just rushing to judgement based on a press release), I will continue to believe that you are truly driven to do the right thing for the public's safety -- I will believe in you like I used to believe in Santa Clause or the Tooth Fairy.  Don't let me down.  

 

#  #  #  #

 

NEW YORK, March 23 NY-FDA-lawsuit-Plan-B

FDA Ordered to Make a Decision Based on Scientific Fact, Not Politics

 

source: http://bit.ly/4sSFi7

 

NEW YORK, March 23 /PRNewswire-USNewswire/ -- Today, the U.S. District Court for the Eastern District of New York rejected the Food and Drug Administration (FDA) decision to limit over-the-counter access to the emergency contraceptive Plan B to women over 18, ruling that it was based on politics and ideology, rather than science. The court ordered the agency to reconsider its decision.  It also ordered the FDA to act within 30 days to extend over-the-counter access, which is currently limited to 18 year olds and over, to 17 year olds.

 

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the Center for Reproductive Rights, which brought the suit against the FDA.

 

"The message is clear -- the FDA should put medical science first and leave politics at the lab door.  We are encouraged that the agency, now under new leadership, will take that message to heart."

 

The Center for Reproductive Rights sued the FDA in 2005 for failing to grant over-the-counter status to Plan B against the advice of scientific experts and in violation of its own procedures and regulations.  In 2006, the FDA agreed to make Plan B available without a prescription, but only to women over 18 and only behind the pharmacy counter.  The Center continued to pursue its lawsuit, Tummino v. von Eschenbach, to ensure that Plan B would be granted true over-the-counter status and made available to all women, including young women who might benefit most from this form of contraception.

 

"According to the FDA's own rules, the only legitimate criteria for making a drug available without a prescription are safety and efficacy," said Northup. "Emergency contraception is proven safe and effective and today, all women -- including young women for whom the barriers and the benefits are so great -- are one step closer to having the access they need and deserve."

 

The Court found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays."  In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns."

 

Before its action on Plan B, the FDA had never restricted a non-prescription drug based on a person's age, nor had the Bush Administration ever been consulted by the FDA about an over-the-counter drug application.  Depositions of senior FDA officials by the Center in 2006 indicated that the Bush Administration sought to unduly influence the agency during the Plan B application review process.  Testimony also indicated that officials involved in the decision-making process were concerned about losing their jobs if they did not follow the Administration's political directives.

 

Other evidence uncovered during the lawsuit showed that the agency repeatedly departed from its own established procedures during the FDA case, from filling the reproductive health committee with political "operatives" to making a decision to reject over-the-counter access to Plan B before completion of the standard review. 

 

The Center's battle to make Plan B available over-the-counter to women of all ages began in 2001, when it filed a citizens' petition with the FDA on behalf of over 70 medical and public health organizations to grant the drug over-the-counter status.   On January 21, 2005, the Center filed Tummino v. von Eschenbach in the U.S. District Court for the Eastern District of New York on behalf of the Association of Reproductive Health Professionals (ARHP); National Latina Institute for Reproductive Health; individuals from a grassroots advocacy group, the Morning-After Pill Conspiracy; and parents who seek over-the-counter access for their daughters.  On March 30, 2007, the Center asked for summary judgment in the case, arguing that the evidence gathered during discovery made it unnecessary for the court to hold a trial and that the court should order the agency to make Plan B available without a prescription to all women.

 

For more information on this case and the Center for Reproductive Rights, please visit www.reproductiverights.org.

 

The Center for Reproductive Rights is a nonprofit legal advocacy organization dedicated to promoting and defending women's reproductive rights worldwide.

 

CONTACT: Dionne Scott
(917) 733-4357
DSCOTT@REPRORIGHTS.ORG

Liza Tanner
(202) 207-3645
ltanner@prismpublicaffairs.com

Digital Marketing: Giving it Some "Pull"

Digital Marketing: Giving it Some “Pull”

By Laura Pfister, VP, Interactive Media & SEM at Ignite Health (www.ignitehealth.com).

source: PM360 (http://www.pm360online.com/ESource_0309)

As THE NATION’s economic woes continue to MuLTIPLY we are left with the challenge of becoming even more efficient with our marketing dollars. This requires product managers to consider how to squeeze every ounce of value out of their existing assets while devising highly efficient ways to drive visibility.

Perhaps one of the best ways to “drive” this visibility is not with a push strategy, but instead focusing on the power of a pull-through approach. One of the ways to accomplish greater reach of existing assets involves integrating and syndicating key assets at the natural consumption points of your target audiences in their preferred media formats.

Hit Moving Targets
Both patients as well as physicians possess fragmented Internet usage patterns. For example, a newly diagnosed breast cancer patient will oftentimes utilize a search engine, followed by a health portal and online message boards (i.e., YouTube, Facebook support groups, etc.). That presents us with a challenge of an ever-moving target. But at the same time we have the possibility of multiple touch points to communicate with this individual.

Likewise, your healthcare professional (HCP) audience is frequenting news, journal, peer-to-peer social groups and Wikipedia, and reaching this group has become equally fragmented. The critical key to success is determining the most efficient means to leveraging this behavior. By leveraging these natural occurrences, you no longer have to support the burden of driving traffic to your web property or assets, but instead, you leverage the volume of traffic a particular destination already has in the form of existing dedicated traffic.

Online video consumption has continued to increase over the past year. The Pew Internet and American Life reports that 48% of Internet users visit a video-sharing web site, such as YouTube, up from 33% in December 2006. This upward trend indicates significant opportunity to leverage many of the video assets we possess, from patient testimonials to general disease awareness information. By dusting off these assets and uploading them onto video sharing sites we can exponentially increase their possible reach and exposure. Additionally, you are providing information in the compelling format that your target audience is actively seeking.

Bear in mind, these types of syndication activities need to be strategically thought through and treated like any other marketing tactic to ensure legal soundness. For example, turning off the ability to comment on the videos, posting patient-safety information links, etc. are critical components to properly syndicating your video content and should not be forgotten. However, these components shouldn’t be seen as a barrier to entry as they are easily overcome and, when properly implemented, can provide additional reach and traffic for a lengthy period of time.

Making a Connection
Online video is no stranger within the physician community either, as well as portable media devices, such as iPods. One strategy to leverage both of these trends in a cost-effective manner is to continue your messaging to this audience by posting your KOL video series or other relevant information in a podcast format on iTunes. This allows for your HCP target audiences to download them and listen to them at their leisure, whether on their commute or during their lunch hour.

Social networking is an activity that continues to grow at an astonishing pace. According to a recent Pew Internet report, 35% of adults online have used a social networking site, such as MySpace or Facebook. Facebook alone possesses over 150 million active users and a surprisingly large volume of health-related groups, pages and conversations. By creating a group for your indication or participating in an existing conversation, you could bring significant reach to your unbranded messaging. Likewise, if you have KOLs within the HCP audience, you can amplify their reach on peer-to-peer communities, such as Sermo, Medscape Connect, and Ozmosis.

While the possibilities above are just a few strategic examples of effective syndication to jump start the ideation process, there are many other practical applications. These unprecedented times require that we think strategically about syndication by leveraging existing assets and expanding their reach among our target audiences through the mediums that they are already consuming. This methodology will allow us to achieve greater campaign success within our tightening budget parameters.

Laura Pfister is VP, Interactive Media & SEM at Ignite Health. She welcomes comments at lpfister@ignitehealth.com.

 

The TWT Poll Results Are In: I'm not so crazy after all!

A few weeks ago I posted my twitter community a question:

"What do you think of the idea of an FDA Universal Widget that all pharma Websites would display on their online initiatives?"

This idea was suggested especially as a way to enable pharma to participate in social media, while ensuring that (a) they are being compliant with the FDA, (b) providing the community a benefit, and (c) all the while looking out for the patients' best interests -- and safety.

The results are in: 60% of respondents feel the idea was Good-Great-or-Excellent. Feel free to take the poll, or send me any additional thoughts on twiiter @skypen. Thanks!

twtpoll ::To all pharma marketers: A universal FDA Adverse Event widget required by all pharma websites (brand, disease, social) would be effective?

twtpoll ::To all pharma marketers: A universal FDA Adverse Event widget required by all pharma websites (brand, disease, social) would be effective?

Posted using ShareThis

AMAZING: Now You Can Talk to Twitter and Find Clinical Trials

Now You Can Talk to Twitter and Find Clinical Trials
<http://blog.trialx.org/2009/03/now-you-can-talk-to-twitter-and-find.htm
l>

Source: http://bit.ly/3dl8nH

Twitter <http://www.twitter.com/> is emerging as a popular method of
expression and communication through short updates (or micro-blogging)
and has seen rapid growth in the last few months. The service is used by
people to "update" what they are doing and apprising them of "what's
happening" by following updates of others. There are estimated
<http://en.wikipedia.org/wiki/Twitter> 4-6 millions users of Twitter
sending more than 2 million messages every day.

So how can Twitter be used to increase information availability of
clinical trials and thus speed up the development of life-saving
medicines? Well, there are many users on Twitter, who happen to be
looking for clinical trials or even participants discussing research
studies. For example, "@hjhunter is looking to participate in a clinical
trial" or "@k_herb Being a participant in a clinical trial food study is
super fun". We wanted to help users like @hjhunter to find matching
clinical trials, something we already have at TrialX
<http://www.trialx.org/> , from Twitter itself. Hence, we developed a
TrialX Twitter app to serve this user need and enable patients to find
clinical trials personalized to their health needs.

Click here for the full article: http://bit.ly/3dl8nH

New data on Social Networking Demographics: Boomers Jump In, Gen Y Plateaus

Social Networking Demographics: Boomers Jump In, Gen Y Plateaus

Source: Micropersuasion

There's a common misperception out there that all of the blogging, Twittering and Facebooking is being done by twenty and thirty-somethings. That, in fact, turns out not to be true. Baby Boomers (those born 1946-1964) are the fastest growing users of social networking sites and are also increasingly reading blogs too. Meanwhile, Gen Y interest in these services has plateaued. This all according to the latest Consumer Electronics Usage Survey from Accenture.

Read more: http://bit.ly/12M2jX

Med Ad News Magazine Announces Nominees for the 20th Annual Manny Awards

Med Ad News Magazine Announces Nominees for the 20th Annual Manny Awards
as Well as Advertising Person of the Year

NEWTOWN, Pa., March 17, 2009 -- Source: Med Ad News

<http://ad.doubleclick.net/jump/PharmaLive/news;sz=300x250;abr=!ie4;abr=
!ie5;ord=1237831434286?>

Med Ad News announces two new Manny Award categories along with this
year's nominees. Med Ad News will hold its 20th annual Manny Awards on
Wednesday, April 22, 2009 at the Sheraton New York Hotel and Towers. The
Manny Awards is an annual gala event celebrating creative excellence in
healthcare advertising in several award categories.

The Heart Award is a new award created by the Med Ad News editorial
staff to recognize agencies' social responsibility and commitment to
philanthropic and social causes. Nominated agencies will receive a cash
donation from Med Ad News for a charity of the agencies' choice.
Nominees for the Heart Award are:

* The CementBloc Inc.
* Draftfcb Healthcare
* Purohit Navigation Inc.

Also new to this year's event is The Vision Award, which recognizes
exceptional ideas and initiatives that have the power to transform the
way that healthcare advertising agencies do business. Vision Award
nominees are:

* The CementBloc Inc. for 90-Day Expedited Brand Building
* Euro RSCG Life for Havas Drive
* McCann Healthcare Worldwide for McCann HumanCare Salud and Momentum
Wellness

Advertising Person of the Year is Donna Tuths of Ogilvy Healthworld US.

Advertising Agency of the Year Category I nominees are:

* AbelsonTaylor Inc.
* Cline Davis & Mann LLC
* Draftfcb Healthcare

Advertising Agency of the Year Category II nominees are:

* The CementBloc Inc.
* Euro RSCG Life MetaMax
* Torre Lazur McCann

Advertising Agency of the Year Category III nominees are:

* Blue Diesel LLC
* Revolution Health LLC
* Wishbone/ITP Inc.

Best Consumer Advertising Campaign nominees are:

* Brand Pharm (Differin campaign)
* CommonHealth (Symbicort campaign)
* Saatchi & Saatchi Consumer Health+Wellness (Ambien CR campaign)

Best Disease-Awareness Campaign nominees are:

* Draftfcb Healthcare (Psoriasis/Centocor Inc. campaign)
* Dudnyk (Check Iron Early and Often/AMAG Pharmaceuticals Inc. campaign)
* GSW Worldwide (Dosing Matters/Covidien AG campaign)

Best Interactive Campaign nominees are:

* Blue Diesel (Concerta campaign)
* Digitas Health (Diabetes in America campaign)
* Ignite Health LLC (MyInnerstate.com campaign)

Best Philanthropic Campaign nominees are:

* GCG Healthcare (Children's Neuroblastoma Cancer Foundation campaign)
* GSW Worldwide (Homeless Families Foundation campaign)
* Palio (Grace campaign)

Best Professional Advertising Campaign nominees are:

* CDM Princeton (Risperdal Consta campaign)
* Cline Davis & Mann LLC (Lucentis campaign)
* Corbett Worldwide Healthcare Communications (Vigamox campaign)

Best Self-Promotion Campaign nominees are:

* AgencyRx LLC
* The CementBloc Inc.
* Ogilvy Healthworld US

Most Creative Agency:

* Cline Davis & Mann LLC
* Palio
* Saatchi & Saatchi Consumer Health+Wellness

Med Ad News congratulates all nominees and anticipates an exciting 20th
Manny Awards celebration, which will begin with cocktail hour at 6:30pm
and continue with a sit-down dinner at 7:30pm. Black tie is optional.
Hotel rooms have been reserved for guests. For reservations and hotel
room information, contact Francine Stone at 215-944-9827, or
Francine.Stone@cancom.com.

About Med Ad News
The pharmaceutical industry's publication of record for 25 years, Med Ad
News provides broad coverage and incisive analysis of the issues,
events, trends, and strategies shaping pharmaceutical business,
marketing, and sales. More than 16,000 readers - comprising corporate
executives, marketing, sales, and product managers - receive Med Ad News
12 times per year. Med Ad News is a publication of Canon Communications
Pharmaceutical Media Group.

About Canon Communications Pharmaceutical Media Group
A division of Canon Communications LLC, Canon Communications
Pharmaceutical Media Group is a provider of business and marketing
information to the $500 billion worldwide pharmaceutical industry. The
group publishes well-established business magazines, including Med Ad
News and R&D Directions, and Pharmaceutical and Medical Packaging News,
and the industry Website PharmaLive.com. The Canon Communications
Pharmaceutical Media Group corporate mission is to be a leading provider
of business, marketing, and clinical-research information to the
pharmaceutical industry.

New study shows consumers far more digitally savvy than agencies

New study shows consumers far more digitally savvy than agencies

March 23, 2009

-By Noreen O'Leary <mailto:noleary@adweek.com>

NEW YORK Ad agencies are years behind in catching up to digitally savvy
consumers who are moving their media habits online more quickly than
expected, according to new global research from the IBM Institute for
Business Value.

IBM found that between 2007 and 2008, the proportion of consumers saying
they used social-networking tools soared to 60 percent from 33 percent;
for online and portable music services it more than doubled to 46
percent; mobile Internet nearly tripled to 41 percent; and access to
mobile music and video quadrupled to 35 percent.

In contrast, 80 percent of the ad executives interviewed expect the
industry to be at least five years away from being able to deliver
cross-platform advertising, encompassing sales, delivery, measurement
and analysis.

IBM also found that interactive, measurable formats like the Internet
and mobile are expected to account for 20 percent of global ad spending
by 2012. Some 63 percent of the global CMOs who were interviewed said
they expected to increase interactive and online marketing spending in
2009 while 65 percent will cut back on traditional advertising.

Study co-author Saul Berman, IBM global leader, strategy and change
consulting services, said agencies need to understand the value shift --
and the parallels with what has happened in the music industry.

"It's very hard to accelerate analog dollars into digital pennies,"
Berman said. "Where will the money come from? The answer may be, 'You're
going to make less money.' The money may be going somewhere else in the
value chain. The music industry didn't lose money, the music companies
lost money. Companies like Apple, which manufactures devices, make
money, as [does] ring tone providers, retailers like Best Buy and
concert promoters."

The lessons to be learned, per IBM: Traditional industry players need to
identify ways to monetize new consumer experiences before new entrants
do; and there are significant new consumer opportunities-beyond just the
value of content through value-added services, hardware and software
offerings.

For its research, which will be released this week, IBM conducted 70
interview sessions with global industry execs and surveyed more than
2,800 consumers in Australia, Germany, India, Japan, the U.K. and the
U.S.

DOWNLOAD IBM RESEARCH:

"Beyond Advertising"
<http://www.adweek.com/aw/photos/stylus/75848-BeyondAdvertising.pdf>

"Succeeding in the New Economic Environment"
<http://www.adweek.com/aw/photos/stylus/75849-NewEnvironment.pdf>

Doctors increasingly close doors to drug reps, while pharma cuts ranks

Doctors increasingly close doors to drug reps, while pharma cuts ranks

Many physicians see detailers only with scheduled appointments. Drugmakers are responding to hard times with layoffs and a shift toward online marketing.

By Kevin B. O'Reilly (AMNews staff)
Posted March 23, 2009.

Source: http://www.ama-assn.org/amednews/2009/03/23/prl10323.htm#s1

________________________________

The relationship between doctors and drug reps may never be the same again.

Pharmaceutical companies -- battered by a sluggish drug pipeline, the looming loss of blockbuster patented drugs, an economy in recession and scrutiny of their relationships with physicians -- are re-examining the value of sending drug reps into doctors' offices. Detailers are struggling to grab a shrinking slice of physicians' valuable time and attention while adjusting to new drug industry rules banning freebies such as pens and notepads.

At its peak in 2007, the American pharmaceutical industry fielded 102,000 sales reps, said Chris Wright, managing principal for the consulting firm ZS Associates' U.S. Pharmaceuticals Practice. Drugmakers have slashed the number to 92,000 since then, and ZS projects the number will fall to 75,000 by 2012 at the latest, saving the industry $3.6 billion.

Pharma's return on investment in its sales force has plummeted. For every 100 reps who visit a practice, 37 place their products in the office's sample cabinet, and only 20 speak to a physician in person, said the New York-based consulting group TNS Healthcare. Profit per drug rep visit fell 23% from 2004 to 2005, said a February PricewaterhouseCoopers report on pharma's future.

"The old sales model is broken now, and who knows how it will look in the future," said Peter H. Nalen, president of Compass Healthcare Communications, an online drug marketer in Princeton, N.J. "What's happening is that pharmaceutical companies are realizing there are other ways to reach the doctor instead of banging on the door of the doctor who just doesn't want to talk to you."

1 in 4 doctors works in a practice that refuses to see drug reps.

The time squeeze and the new drug industry rules are "changing the landscape quite dramatically," Nalen said. Another troubling sign for drugmakers: More than a third of medical schools require drug reps to have appointments before seeing physicians or residents, according to the American Medical Student Assn.'s 2008 PharmFree Scorecard. The Assn. of American Medical Colleges recommended the by-appointment-only policy in May 2008.

While most physicians still have positive views of detailers and drugmakers, those sentiments are cooling.

About one in four physicians works in a practice that refuses to see drug reps. Of doctors who do see reps, about 40% will meet with detailers only with scheduled appointments. The by-appointment-only figure jumped 23% during the last six months of 2008, according to a survey of more than 227,000 medical practices representing 640,000 physicians that was released in February.

The survey, conducted by the doctor-profiling firm SK&A Information Services Inc., did not seek to determine why some physicians are giving drug reps the cold shoulder. But physicians and pharmaceutical industry consultants say doctors have felt besieged by the number of reps visiting their offices and taking up precious time in an era of declining payment.

Last year saw a slight drop in a measure of the quality of detailers' relationships with doctors, based on a TNS survey of more than 1,500 doctors. And negative word-of-mouth about pharma rose sharply among physicians -- this so-called market-resistance index jumped 62% in the last year, TNS said.

Controversies over the drugs marketed as Vioxx (rofecoxib), Avandia (rosiglitazone) and Vytorin (ezetimbe and simvastatin) appear to be making doctors more skeptical of drugmakers as an information source, said Jerome L. Avorn, MD, professor of medicine at Harvard Medical School in Massachusetts.

"Doctors are increasingly concerned that the sales pitches from drug reps are not giving them the full story," said Dr. Avorn, author of the 2004 book, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.

Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said in a statement that detailing visits are good for doctors and patients. "Interactions between physicians and pharmaceutical company representatives benefit patient care through the exchange of information about new medicines, new uses of medicines, the latest clinical data, appropriate dosing and emerging safety issues."

Interacting with detailers

For every physician, it seems, there is a different way to handle drug reps.

Charles E. Crutchfield III, MD, is a dermatologist with a high-volume practice in Eagan, Minn., a suburb of Minneapolis. Though five to 10 reps visit his office daily, he strictly limits detailers to one five-minute session a week and requires that the rep provide lunch for his staff.

More than a third of med schools require drug reps to make appointments.

"The reps know they are not allowed to disturb me when I am seeing patients," Dr. Crutchfield said. "If they do bring samples, I have a nurse who will bring the pad back to me so I can sign it. I will not see or talk to reps when I'm in clinic."

Ari Silver-Isenstadt, MD, persuaded the four other doctors and officestaff in his Baltimore pediatrics practice to adopt, in January 2008, a "no soliciting" policy for drug reps. Dr. Silver-Isenstadt is a member of the National Physicians Alliance, whose Unbranded Doctor Campaign urges physicians to refuse industry gifts and stop seeing drug reps.

Despite the new survey figures showing that doctors are cooling to drug reps, he said physicians should be more aggressively addressing the conflict of interest detailers pose.

"More than half of us doctors still just have a feeding frenzy of reps in our offices," he said. "We should be ashamed of ourselves for allowing such an intertwining of our patients' best interests with the convenience and niceties of drug reps."

Not all doctors share Dr. Silver-Isenstadt's hard-line view.

Most are simply pressed for time. Drug companies are trying to reach out to doctors via the Web, experts said. About 45,000 doctors meet with detailers using online video, and 300,000 physicians say they are open to doing so, said a September 2008 study from Manhattan Research, a drug marketing research firm.

Visits by drug reps will not disappear entirely, experts said. Rather, the sales force that survives the layoffs will be better trained and have a greater depth of clinical and scientific knowledge.

Detailers "reach the customer in a way that other promotional techniques do not," said Wright, of the ZS Associates consulting firm. "And for many of these doctors, the choices they make about what to prescribe are worth a considerable amount of money.

"When that's on the table, it makes sense to send a highly trained person to make sure the doctor knows about the medicine before making those choices."