Full article reprinted from "The Gray Sheet" - October 05, 2009
Companies should be clear on their Web sites and at international medical conferences which country or countries their promotional materials are intended for, international marketing experts advise. Read more...
Full article reprinted from "The Gray Sheet" - October 05, 2009
Companies should be clear on their Web sites and at international medical conferences which country or countries their promotional materials are intended for, international marketing experts advise.
Because the approved indications for a medical device or drug may vary from country to country, firms need to guard against the appearance of promoting products for an unapproved use in their global marketing, Mary Jane Nehring, executive director-global regulatory affairs at Schering-Plough, said Sept. 21 at the Food and Drug Law Institute 21 Annual Advertising and Promotion Conference in Washington, D.C.
"It is the electronic age and things very easily cross borders," Nehring said during a panel session on international promotions. "We struggle sometimes when [promotional information] crosses borders, or we go to a major international conference and there are physicians there from around the world."
One solution, she said, is to explain on the Web site or in conference material that labels may vary by country, and to specify which country the advertised indication is approved in.
"Disclaimers don't fix it all, but at least the intent is there," Nehring said.
"Our friends in Hungary should be able to promote their label if it has more than the two indications we have in the U.S. ... but very prominently on the first shot [of the Web site] you should say that it's intended for an audience and physicians in Hungary," Nehring said.
By the same token, at an international medical meeting in France, where companies would hand out French labeling and a French package insert that might be very different from what accompanies the product in the U.S., "You would make sure that you have that disclaimer, 'This is the approved package and efficacy in France,'" Nehring explained.
While language differences can "constrain access and sharing" online, the problem of internet information crossing national boundaries becomes particularly relevant with respect to the various English-speaking countries, Anne Edwards, director of customer engagement at McCann Healthcare in London, noted.
Panelists suggested that companies mark their Web sites with the flag of the country for which the information is intended.
Unlike in the U.S., where FDA and the Federal Trade Commission regulate advertising of medical products, overseas industry associations frequently "exercise a lot of the day-to-day regulation of the industry through industry codes," according to Jeffrey Francer, assistant general counsel at the pharmaceutical trade association PhRMA (Pharmaceutical Research and Manufacturers of America).
"Some of the punishments that have been meted out by industry associations include, for example, getting kicked out of the industry association for a certain amount of time ... so you lose some sort of advocacy and the ability to have your complaints adjudicated in that system," Francer said.
The EU is taking a "more active stance" with respect to medical product marketing, though it has not quite accelerated to the level of the U.S. Department of Justice or HHS Office of the Inspector General, Francer said.
Developing A Global Marketing Strategy
Companies can guard against pitfalls when marketing abroad by putting in place a global advertising and promotion strategy that is flexible enough to work with a variety of regulatory systems, the panelists said.
Marketing standards are similar throughout the world, though each country may have slightly different requirements, Schering-Plough's Nehring said.
"Promotion has to be fair and balanced, it has to be on-label and you have to have scientific data to support it ... whether it's in the U.S. or whether you're sitting in Taiwan reviewing materials," she said.
A global policy should reflect input from the company's local country operations, Nehring underscored.
"Pick a small team, pick a country where their regulations are very strict, versus ones that might be a little bit more flexible, so that you can see the wide range of what would be acceptable ... so that when it goes out to countries, it's not so difficult to translate that back into their local practice."
To stay abreast of different indications in different countries and keep claims on-label, Wyeth looks to country core data sheets, European Union summaries of product information and U.S. prescribing information, according to Diane Mitrione, Wyeth assistant VP-Global Regulatory Affairs.
"We don't have every product as a globally promoted product and so the local country really is the final say on what's going to be OK," she added. "At headquarters I cannot know all the rules for 100-plus countries."
To keep distributors outside the U.S. in line, Wyeth audits for promotional practices, Mitrione added.
"We audit labeling in-country versus core data sheets [and] we audit promotional materials versus these global general claims ... [and] we have a corporate culture that people will listen to audit findings."
Also important to take into account are the various countries' different health care systems, McCann Healthcare's Edwards pointed out.
While many countries do not have a Web site similar to the U.S. FDA's, where companies can find violation letters to see what types of promotional violations are being targeted for enforcement, some countries do have a gazette where such complaints are listed, Nehring said.
Also, the International Federation of Pharmaceutical Manufacturers Associations, which includes about 50 associations worldwide and their companies, have jointly set "at least very minimal standards globally for what should be appropriate," according to PhRMA's Francer.
These standards include promoting products only in countries where they are approved and keeping promotion consistent with product information, he added. They also provide some guidelines on how to conduct promotional meetings.
"I think more and more we're seeing that the standards of promotion are becoming more uniform," Francer said.
- Ingrid Mezo
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