NEW JERSEY, December 17, 2001: Our take on the year that was. For the record, this will probably be the first "year in review" article that you will read about the pharmaceutical community...

In the year 2001, pharmaceutical marketing made more headlines and gained more attention than ever before. Profesionals, politicians, and pundits. Legislators, lawyers, and litigants. Regulators, reviewers, and researchers. It seemed everyone was focused on pharmaceuticals. Here's a short review of the big stories that made headlines this year...

AIDS. The AIDS crisis in Africa. It's still a crisis today. But thanks to the compassion of dozens of pharmaceutical companies like Merck and Bristol-Myers Squibb, who worked out specials deals with African governments, it has been possible for patients in the region to receive powerful HIV medications at reduced prices. Access to these life-saving medications, however, remains one of the most challenging hurdles to successful treatment of the millions of suffering families.

Human genome. 2001 saw the publishing of the human genome. Of course, the implications of this have yet to be fully realized, but experts agree that this milestone in medicine has the potential to revolutionize the life sciences, indeed, the science of life.

FDA. There was Jane Henney's departure from the FDA in January -- her post still remains open. There was also some serious buzz about sweeping changes in the way new drug applications are reviewed, as well as overhauls for package inserts and DTC advertising regulations. We haven't heard much lately, though, about this. Recently, the FDA warned us about its lack of funding and how that may delay the drug reviewal and approval process.

Warnings. However, not having a top gun or top dollars didn't stop the FDA from cracking down on pharmaceutical marketers at medical conventions. Nearly every mega-pharmaceutical company got a warning letter from DDMAC about violations that occured at the promotional booths during major medical meetings. Did your brand get one? Be careful -- what your reps are saying is being monitored -- it isn't enough to ensure the accuracy of your printed promotional materials. Now you truly have to watch your mouth -- literally -- because the FDA is too.

Technology. E-marketing. This year we saw the emergence of e-detailing -- which has evolved into an engaging, cost-efficient way to expand one's marketing reach. Companies like MyDrugRep.com and iPhysician.net are paving new trails in online pharmaceutical marketing. And other advances such as e-prescribing through companies like ePocrates and other PDA-based applications companies are driving fundamental changes in the business of drug marketing.

Generics. 2001 saw the ascension of the generic company as a major influence on the industry. While several blockbuster brands continue to face patent expiration, these "copycat" drug makers will continue to ride the trends: as baby boomers continue to age, the markets for many older brands continue to expand, and generic drug companies will meet these growing needs nicely. And talk about tough -- these companies have some of the most tenacious legal departments we've ever seen. Companies like Barr, Andrx and Teva have all been defining how best to bring generic brands into being -- from the lab room and the courtroom. And speaking of court...

Lawsuits, lawsuits, lawsuits. Litigation QD. Rezulin. Prilosec. BuSpar. Baycol. All the big pharmaceutical companies were in court for one reason or another. Safety issues, conspiracy to block generic versions of blockbuster brands, collusion to keep prices high -- we heard a lot of testimony. But the biggest -- and most serious case in finanacial terms-- has to be Rezulin. Stay tuned. UPDATE 12/18: A jury said that Rezulin was not responsible for a woman's death in first Rezulin lawsuit.

Legislation. This year, almost 60 new bills were being considered by state legislators, who were attempting to revise everything from DTC marketing to the very prices of Rx brands themselves. West Virginia, Massachusetts, Connecticut, Maine, and New Mexico all wanted to pass new laws that forced drug companies to disclose data regarding all marketing expenditures. And there were some conflicting reports about changes to laws that govern DTC marketing itself...

DTC. Surprise: One study said DTC marketing works. The most advertised brands, we "learned" in 2001, are also the most widely prescribed. Other studies claimed that DTC ads were short on information, long on selling. What really may have been a surprise was the ongoing reform in the UK. While certain brands are now allowed to promote directly to consumers, citizen and consumer groups in the EU are not in favor of DTC ads. One report promised "disastrous consequences" if DTC advertising is allowed in Europe.

New bashing. Speaking of disasters...all of the news stories listed above prompted lots of criticism of the pharmaceutical marketing community. Public Citizen. Ariana Huffington. Sidney Wolfe. Ethic Ad. The harrangues were often harsh, and we think, unfair. Some likened our industry to "big tobacco." That may have been the biggest slur we saw. Sure -- when you're the most profitable industry in the US, you have to expect some negative press. But tobacco? That was ignorance talking...

New meds. Almost 100 new HIV drugs are being studied right now. New agents in emerging therapeutic classes fill pipelines. Alliances with biotechnology companies have shed new light on existing diseases, and have helped usher in exciting new therapies. ARBs. Targeted oncology agents. Superstatins. Better COX-2 inhibitors. The fact is, we're leading the way in keeping people healthy. There is much to be proud of in the Rx community. Again, stay tuned.

New hope. But perhaps the biggest story of the year is the pharmaceutical industry's response to terrorism. In the aftermath of 9/11, we can look back with pride at how our industry responded with speed and assurance, and how our scientists helped lead the battle against bio-terrorism. Sure Cipro made all the headlines, but we're proud that we were decribed as "defense contractors." American ingenuity met American patriotism. When faced with new and dangerous biological weapons, the US government turned to us, the Rx industry. And while the threat still continues, we're glad to see that criticism turned to praise -- even if for just a few weeks.

In the new year, we will continue to be the premiere resource for pharmaceutical marketing information on the internet. We wish you peace, prosperity, and the continued pursuit of good health. And we remember in a special way all the families who were touched by the events of 9/11. Our hearts, thoughts and prayers are with you.

Have a Happy Hannukah, a Merry Christmas, and a Peaceful New Year. See you on the second of January.

Peace, The Editor.

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