DTC advertising

FDA enters (fake) advertising business

Christe Bruderlin-Nelson — Wed, 06 Aug 2008 10:32:54 -0400

The FDA might be creating some faux direct-to-consumer commercials for a pretend blood pressure medication, which it plans to follow with an internet survey of 2,400 adults to gauge the response of consumers aged 40 and older to the ads.

The agency wants to test whether the safety warnings it requires in ads take a backseat to the images in the ads, and says it issues warnings to multiple companies every year about misleading ads and ads that overstate a products safety or efficacy.

If approved, the fake ads will have various images and text onscreen while a narrator reads warnings. Then the follow-up surveys will attempt to gauge viewer attitudes and perceptions regarding the adds. The FDA submitted the study to its Office of Management and Budget for approval. Stay tuned.

- read the Pharmalot blog post
- get the story at the Star-Ledger

Pharma aims to forestall DTC legislation

Tracy Staton — Fri, 18 Jul 2008 09:37:54 -0400

Pharma industry lawyers descended on the U.S. capital this week to meet with House Energy and Commerce Committee staffers, hoping to forestall legislation that could limit drugmakers' ability to advertise their products, the Wall Street Journal Health Blog reports. As you know, that committee has been dogging pharma on its DTC advertising practices all year, and it staged a tough hearing on the subject in May.

So attorneys from PhRMA, the trade group, made the pilgrimage to counter some of the committee's proposals on DTC limitations. The association has been working on updating its voluntary guidelines--akin to the doc-gift-and-disclosure code announced last week--in hopes of forestalling legislation. Chairman John Dingell told the Health Blog that if PhRMA's new guidelines show a "serious effort to resolve the issues," then the committee will hold off on any more embarrassing hearings. But, he added, "The Committee... expect[s] results within a credible timeframe or we will be forced to consider whether a public airing would be a more productive way to proceed." Uh-oh.

- read the Health Blog post

Tauzin: Pharma must embrace new code

Christe Bruderlin-Nelson — Wed, 16 Jul 2008 10:41:40 -0400

The current PhRMA president was full of cagey cautions during a conference call with drug makers. "Your house is on fire, and you're still smoking in bed," said the former Louisiana Republican congressional representative, Billy Tauzin, also known as "The Cagey Cajun."

Last week PhRMA announced a new voluntary code for drugmakers and had been working on creating a more comprehensive DTC code, but on the latter, a few large members were ahead of the curve.

Earlier this year, following the a particularly excruciating House hearing in May regarding direct-to-consumer advertising, at least a few companies announced temporary moratoria on ads for new medications and said they would reconsider and limit the roles of physicians in their ads. J&J, Merck, Pfizer and Schering-Plough made those announcements just a few weeks after the hearing.

Now Tauzin says he'll be happy if those companies and others adopt new guidelines that prohibit pens, mugs and drug dinners.

However, some are saying the revised PhRMA code doesn't do nearly enough. According to The Boston Globe, "the revised PhRMA code is neither adequately enforced nor sufficiently stringent to end this unethical marketing practice," in an article that said a law would do the trick, not a code. "The industry has been allowed to self-regulate for years and evidence shows the giving of inappropriate gifts and payments continues to increase significantly."

"Our members were advertising life-saving medicines like it's Pepsi, and that hurt us," Tauzin said.

- get the WSJ blog take
- read more at the Boston Globe

Drugmakers to delay new-drug ads

Tracy Staton — Tue, 17 Jun 2008 09:25:00 -0400

There's a waiting period for marriage licenses, IPOs, and flood insurance--and now, drug advertising. Several big drugmakers called on the Congressional carpet for their advertising campaigns now say they'll wait six months after FDA approval to start touting new meds to the public. They also said they'd follow AMA guidelines for using actors to play doctors on TV.

But Michigan Dems Bart Stupak and John Dingell aren't satisfied with these concessions. They'd asked for a two-year waiting period, for one thing. And as Merck explained in a letter to the House Committee on Energy and Commerce, a six-month quietus after FDA approval is already somewhat customary, because drugmakers like to educate docs about new products before driving patients into their offices with DTC ads. The committee also had asked the companies to advertise drugs only when they've proven effective in outcomes studies.

You'll recall that Stupak and Dingell have been breathing down pharma's neck all year, with hearings on everything from clinical trials to outsourcing to, of course, DTC advertising. The DTC hearing focused on Pfizer's Lipitor ads starring artificial-heart inventor Robert Jarvik, on Johnson & Johnson's commercials for the anemia treatment Procrit, and Merck and Schering-Plough's food-and-family ads for their combo cholesterol med Vytorin.

- see the committee's statement about the six-month wait
- check out the Advertising Age story
- find the post at the Wall Street Journal Health Blog

Survey: Pharma not a good info source

Tracy Staton — Thu, 29 May 2008 10:35:00 -0400

Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Nearly half of the responders said pharma has too many conflicts of interest to be appropriate sources of general information on medications.

Some of the responses, however, indicated that if drug companies provided a clear distinction between ads and information, they could be valuable repositories because of their intimate knowledge of their products.

The opinions will be factored into decisions about a proposed code of conduct governing the release of info about pharmaceuticals in the E.U.

- see the item at Pharmalot
- check out the PharmaTimes story

Facebook, Twitter, ect., new marketing tools

Tracy Staton — Wed, 28 May 2008 10:20:25 -0400

It's a brave new pharma-marketing world out there, with more and more hospitals and docs barring drug reps and companies turning to electronic detailing to get their messages across. But the online sales pitch has just begun. Networking tools like Facebook and Twitter will soon be de rigeur, replacing blogs as the must-use online tools. Or so says the Pharma Marketing Blog, whose author has been experimenting with a handful of connection-making sites and even Google Maps. The logic is tough to argue with, especially with examples like the one from a Dell exec who says the company's Twitter activity brought in a half-million in new business last year.

Coincidentally, there's an item in an internal-communcations trade pub about Pfizer's new RSS feed and its plans for a "Pfacebook" site. The article looks at these two initiatives from an internal point of view, but how long can it be before the drugs giant uses similar means to reach its customers?

- read the Pharma Marketing item
- check out a BusinessWeek story about e-Marketing
- find the Pfizer piece at the Internal Communications Hub

Congress asks CEOs to pledge truth in DTC

Tracy Staton — Wed, 21 May 2008 10:24:15 -0400

Dingell and Stupak strike again. Fresh on the heels of their DTC hearing, the two Congressmen have issued letters to four top pharma execs--CEOs at Merck, Pfizer, Schering-Plough, and Johnson & Johnson--asking them to commit to honest-Abe advertising. "Consumers should not have to rely on the oversight function of Congress to make sure drug companies tell the truth in their ad campaigns," Stupak said, calling DTC advertising a "privilege" that comes with responsibility.

The two men also question the industry's own DTC guidelines. In a separate letter to the Pharmaceutical Research and Manufacturers of America, they say that the guidelines should be updated. Among the suggested changes: Ads for drugs with "black box" warnings have to specifically include that cautionary tale.

- check out the House Energy and Commerce Committee's release
- get the article at CNN Money
- see the story in PharmaTimes

Did FDA counsel save Procrit ads?

Tue, 13 May 2008 06:59:56 -0400

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

Will DTC hearing lead to new regulation?

Thu, 08 May 2008 06:59:56 -0400

Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article
- find the video link at the committee website

DTC hearing has high-powered guest list

Fri, 02 May 2008 06:59:54 -0400

Hail, hail the gang's all here...at the House Subcommittee on Oversight and Investigations hearing on direct-to-consumer ads. Next week, Rep. Bart Stupak will preside over testimony from Pfizer, Merck, Schering-Plough, and Johnson & Johnson. Kaiser Permanente, the GAO, and the AMA may be there, too.

The official title of the hearing? "Direct-to-Consumer Advertising: Marketing, Education, or Deception?' Not surprising, considering Stupak's history as an industry critic, but definitely not comfortable for those scheduled to say their piece. If you're interested, the committee will offer a video feed.

- see the Pharmalot item
- get the link to the webcast at the committee's site