Drug Industry Presses FDA to Allow More Online Ads

pillsAs federal regulators take their first tentative steps toward policing the wild west of medical information online, pharmaceutical companies are pressing their case to market drugs via Google, Twitter and other Web sites.

The Food and Drug Administration will convene a two-day meeting beginning Thursday to hear the drug industry’s position on Internet marketing. The agency has agreed to consider developing rules for online advertising after companies complained that the current guidelines for traditional media — which require a detailed list of possible side effects — have left them hamstrung on the Web.

An estimated 83 percent of Internet users search for health information online, according to a recent survey from the Pew Research Center. A few drugmakers have begun trying to reach patients via social networking sites like Facebook and YouTube. But overall the industry’s online presence trails other sectors, including retail, financial services and computer makers.

In the first half of 2009, pharmaceutical companies represented just 4 percent of the $10.9 billion spent on online advertising, according to a report from PricewaterhouseCoopers. Industry observers say companies have largely steered clear of the Web for fear of running afoul of FDA regulators, who have not defined the rules of operating online.

In a public statement announcing the meeting, the FDA acknowledged that “emerging technologies may require the agency to provide additional guidance.” But some industry experts worry the FDA’s rule development process — which often takes years — cannot keep pace with online innovation.

“What’s happening is these new media are emerging at an increasingly rapid rate, and are being regulated by an agency that moves very slowly,” said attorney Mark Senak, who advises drug companies as a consultant for communications firm Fleishman-Hillard. “In essence, you have a regulatory communication crisis developing.”

The vast majority of the pharmaceutical industry’s roughly $4.5 billion in annual marketing is still spent on traditional TV and magazine advertising, where the rules are clear: all ads that mention a drug must provide a balanced picture of its risks and benefits.

The requirement to disclose risk information demands those long lists of side effects heard during TV and radio spots, as well as the large blocks of small print seen in magazine ads. When drug companies have tried to adapt such ads to the abbreviated language of Google and Yahoo, they’ve run into trouble. In April, the FDA fired off warning letters to Pfizer Inc., GlaxoSmithKline PLC and a dozen other drugmakers for search engine ads that did not mention drug risks.

The ads — called sponsored links — appear on the screen margins of sites like Google when users search for certain key words. With a maximum of just 25 words, the links did not include information about potential side effects, making them illegal, according to the FDA.

On Thursday, the Pharmaceutical Research and Manufacturers of America group will argue that the FDA should relax its standards to accommodate new online approaches to marketing.

In documents released ahead of the meeting, PhRMA suggests the agency develop a logo that could be used in place of hundreds of words about drug risks. The logo would link viewers to the drug’s full risk information, allowing manufacturers to send messages about their drugs on sites like Twitter, which has a 140-character limit.

But industry observers say the online marketing environment is not as restrictive to drugmakers as some suggest. Pharma Marketing News publisher John Mack says drug companies already are free to post abbreviated ads about diseases and treatments — provided they don’t mention a specific product.

“They are very hell-bent on including brand names in their ads,” said Mack. “If all they wanted to do is direct people to useful health information, there are lots of ways to accomplish that.”

PhRMA will also press the FDA to narrowly define drug companies’ responsibility for policing information about their products.

Pharmaceutical promotions can only discuss drug uses that have been cleared by the FDA. But manufacturers worry they could be held responsible for comments about unapproved uses posted by users of blogs and interactive Web sites like YouTube, where some drug companies offer videos about diseases and medical science.

“Pharmaceutical companies control their own sites, their own agents and their own employees,” PhRMA assistant general counsel Jeffrey Francer said in a media briefing Monday. “But there is no sensible basis to hold manufacturers accountable for third-party statements.”

The FDA also is slated to hear from individual drug companies, medical device makers, attorneys and advertising executives.

Even after the FDA transcribes and reviews hours of testimony, the agency will only be in the preliminary stages of crafting new guidelines. According to Senak, the FDA is unlikely to release its final regulations until 2011 — when they may already be outdated.

“The danger is that the agency takes so long to get this done, and done right, that tremendous opportunities are lost,” said Senak.

The FDA did not respond to requests for comment Wednesday morning.

Health & Fitness

JLABS injects some tech into the medical industry

Innovating health care is expensive, risky, and complicated legally. One company is trying to remove these barriers with clever and altruistic approach.
Emerging Tech

Michigan’s former transportation chief has some advice for wannabe smart cities

After 31 years as Michigan’s transportation director, Kirk Steudle has seen it all, particularly with smart city projects. He spoke with Digital Trends recently about what makes smart cities work, and offers advice along the way.
Emerging Tech

Watch this lab-grown heart tissue beat just like the real thing

A team of researchers in Germany have used stem cells to create a lab-grown human heart tissue which actually beats, as well as responding to drugs in the same way as the real thing.
Movies & TV

The best shows on Netflix, from 'The Haunting of Hill House’ to ‘The Good Place’

Looking for a new show to binge? Lucky for you, we've curated a list of the best shows on Netflix, whether you're a fan of outlandish anime, dramatic period pieces, or shows that leave you questioning what lies beyond.
Computing

Want to use one drive between a Mac and Windows PC? Partitions are your best bet

Compatibility issues between Microsoft Windows and Apple Mac OS X may have diminished sharply over the years, but that doesn't mean they've completely disappeared. Here's how to make an external drive work between both operating systems.
Computing

Microsoft turns on the lights with a new white theme in Windows 10 update

Microsoft is introducing a new light theme in the upcoming version of Windows 10 and is currently beta testing the change with Windows Insiders. The clean-looking theme brings a much-needed facelift to Windows.
Computing

Four Andromeda-related Microsoft patents hint at new ways to use the device

Andromeda might be getting even more real as four Microsoft patents have surfaced recently, all of which hint at possible new use cases and other new configurations for the device. 
Computing

Here's why 64-bit (not 32-bit) dominates modern computing

Today's computing world isn't the same as it once was. With 64-bit processors and operating systems replacing the older 32-bit designs, we look at what 32-bit vs. 64-bit really means for you.
Computing

A Google patent shows a way to make VR even more immersive

Virtual reality can be a really immersive experience, but it does sometimes it does have boundaries. Google has addressed this problem by patenting shoes with a flexible region on the bottom.
Computing

Converting files from MKV to MP4 is quick and easy. Just follow these steps

MKV files have their place, but if you would rather convert your videos from MKV to MP4, there are two methods we consider the best and most efficient for getting it done. In this guide, we'll walk you through them step by step.
Computing

Heal your wrist aches and pains with one of these top ergonomic mice

If you have a growing ache in your wrist, it might be worth considering changing up your mouse for something ergonomic. But which is the best ergonomic mouse for you? One of these could be the ticket to the right purchase for you.
Computing

Our 10 favorite Chrome themes add some much-needed pizzazz to your boring browser

Sometimes you just want Chrome to show a little personality and ditch the grayscale for something a little more lively. Lucky for you, we've sorted through the Chrome Web Store to find best Chrome themes available.
Deals

All the Best Target Black Friday deals for 2018

The mega-retailer opens its doors to the most competitive shoppers at 6 p.m. on Thursday, November 22, and signs indicate that the retailer means business this year. We've sifted through all of the deals, from consumer electronics to small…
Computing

Windows 10 notifications driving you crazy? Here's how to get them under control

Are the notifications on Windows 10 annoying you? Here's our guide on how to turn off notifications in Windows, and how to manage alerts so that the important stuff still gets through.