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April 30, 2008
Chinese Connection Doesn't Look Good for FDA
Back in November, I warned that China could ill afford bad publicity as its API market took its first steps into a full-fledged, finished product pharmaceutical manufacturing industry. If their drugs turned out to be no safer than their toys, the FDA would take a huge hit and this new industry would be set back tremendously. Recently a link surfaced between Baxter's generic Heparin and a Chinese API manufacturer that looks quite bad for China.
And while the Chinese plant has absolutely not been established as the cause of the potentially life-threatening reactions, the fact that we may never know makes the FDA look far worse than Chinese industry, because they're absolutely at fault. The Chinese plant has never been inspected, and now that something has gone horribly wrong somewhere, the FDA plans to show up as soon as possible. In the mean time, you can bet that the manufacturers just brought in an oil tanker full of Clorox and a pressure washer, and are currently spraying every inch of the plant down three times.
While major news outlets will probably be focusing on the Chinese connection, or possibly the FDA's lack of Chinese oversight, I think this points to a larger problem at the FDA today. The organization has lost focus on what's most important to ensure consumer safety. The FDA's budget is smaller than it should be; in fact, its task is simply impossible at any budget level. But since you can't physically inspect every piece of fish sold in the local supermarket, or make sure every customer knows the trial results of the drug they're taking, you should make sure you hit the important parts.
The solutions are already being discussed by those in the industry, with the prodding of Congressional leaders. But it's unacceptable that, while the organization responsible for consumer safety deals with advertising regulations, an uninspected plant in China is making a drug which, even when extracted safely, is derived from pig intestines over a process that takes hours if not days. If it wasn't bad enough, these drugs are then shipped to the US for use in heart surgery or dialysis patients, whose bodies are already critically compromised.
Again, we don't know that the Chinese plant is responsible for the problems. But this goes beyond Chinese drug manufacturing. It remains unacceptable regardless of the questionable Herparin's point of adulteration. I wouldn't expect that plant to go uninspected even if it was US-based. It's a stretch to think anyone would disagree with that - and yet this was not an oversight, this was a routine decision at the FDA.
Regulating advertising is important. But given the FDA's limited budget, I'd prefer to know my prescriptions don't include e.coli, chemical precursors, or three times as much of the API as I'm supposed to be taking. This might be the single most important job the FDA has - beyond advertising, and possibly beyond even approval or rejection based on a drug's efficacy. Its effectiveness isn't very important, after all, if it kills you in the process.
Look for even more changes in FDA budgets and priorities in the coming years, as congressional fury rises due to cases such as this one.
Posted by Jeremy Spivey at 04:31 PM | Comments (0)
April 15, 2008
Pharma Should Seize the Opportunity to Reach the Hispanic Market
Pharmaceutical companies are no strangers to market research or targeted marketing campaigns. However, there is a large segment of the market that pharmaceutical companies may not be effectively catering to - the growing Hispanic market. Statistics presented at the ePharma Summit 2008 underscore the importance of the Hispanic market and provide insights into some of the underlying characteristics of this segment.
Jorge Daboub, vice president for marketing and business development at Univision Television Group, presented several interesting statistics about the Hispanic market's use of the Internet. Among some of his points were:
* A 70% increase in Hispanic online web presence since 2000
* 79% of Hispanics have Internet access at home and typically spend the same amount of time as the general population
* Hispanics are 73% more likely than non-Hispanics to be receptive to online advertising, such as video, pop-up ads and email blasts
All of these statistics echo the fact that the Hispanic population can be readily accessed by leveraging strong web campaigns. However, particularly shocking is the last stat about how much more receptive Hispanics are to online advertising than other populations. This statistic is a market researcher's dream and paints an ideal picture for pharmaceutical companies trying to reach this key segment.
In addition to the compelling receptiveness of the Hispanic market to online advertising, pharmaceutical marketers should be conscientious of the vast size the Hispanic market now represents in the U.S. Currently, the Hispanic community is a relatively untapped market for many pharmaceutical companies.
Pharmaceutical marketers should understand that the Hispanic market has distinct characteristics that make it different from other populations and cultures. Therefore, to develop effective marketing campaigns companies must begin with market research and truly understand the nuances that influence this community. However, if pharmaceutical companies absorb cultural insights and design websites and web campaigns that target Hispanics, they might experience notable success in connecting with this segment of the market.
As with most markets, patient education is a great need. This is particularly true for the Hispanic market since a vast amount of educational material is not available in Spanish. Companies that tailor their materials to meet Spanish-speaking audiences will be satisfying a great unmet need.
The opportunity is there. Pharmaceutical companies are sophisticated enough to market effectively market to this segment. The question still remains whether pharmaceutical companies will choose to wholeheartedly pursue the Hispanic market.
Posted by Amanda Zuniga at 08:09 AM | Comments (0)