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Government’s watchful eye has pharma on guard
January 2010
by Amy Swinderman  |  Email the author

Healthcare reform, alleged illegal marketing practices, drug safety concerns, patent expirations, stem cell research—as a new decade dawns, the pharma and biotech industries are caught in the diverse crosshairs of government scrutiny, both in the United States and abroad. As these and other pressing issues play out on the evening news, the editorial team at ddn is keeping our ears to the ground with a new content department. Beginning this issue, our Government Watch section will profile some of the latest legal, legislative, and regulatory developments in the pharma/biotech arenas. The section, which begins on page 38 of this issue, will appear in odd-numbered months throughout 2010.  
In our first month of coverage, we had a veritable grab-bag of stories to sink our teeth into, and settled on a wide range of topics to show our readers the various forms government scrutiny can take: federal oversight, state legislation, state regulation and international regulation, to name a few. Our writers—who are no strangers to reporting on such matters—were eager to hit the ground running and delve into these topics, but were met with an all-too-familiar roadblock: Fear.  
Figuring that our pharma sources would welcome the chance to opine on healthcare reform and other government scrutiny, we hoped to ask the questions, sit back and let the answers flow. We soon learned, however, how cautious most companies are when it comes to such sensitive topics.  
"While working on my story about the impact of healthcare reform on Big Pharma, I encountered more than a few companies that respectfully declined to comment on the issue," says our managing editor, David Hutton, who once covered legislation impacting the appraisal and valuation industries, both on state and federal levels. "I certainly understand why companies might want to decline to comment on legislative issues, but I firmly believe that it is in their best interest to publicly state their positions on key issues to be a part of public discourse on proposals that affect their business, and their bottom line."  
Our writer Lori Lesko lucked out with her story on proposal to limit stem cell research funding in Missouri, but having earned her stripes covering hot topics for the real estate and settlement services industries, she knows all too well how challenging it can be to get sources to open up about sensitive topics.
"With proposed or actual legislation, pharmas should want to weigh in," Lesko says. "Although ddn will cover both sides of an issue, ddn would provide a forum for pharmas to make their case. Giving a 'no comment' or refusing to take phone calls only weakens one's position and casts a shadow on one's credibility."
Speaking for myself, covering an investigation by the Government Accountability Office (GAO) was familiar ground, as I once tackled a highly anticipated probe by the investigative arm of Congress into alleged illegal business practices by the title insurance industry. I recalled how, a year after that explosive report rocked the industry, most of the recommendations the GAO made to resolve some of its concerns failed to see the light of day—similar to what has happened at the U.S. Food and Drug Administration (FDA), as you will read in the story.  
I asked Marcia Crosse, director of healthcare at the GAO about that. "Has the GAO ever measured to what extent its recommendations are followed or implemented?" I wanted to know.
"Oh, yes," Crosse responded. "We have an adoption rate of about 80 percent within four years. Our target rate of adoption is around 70 to 75 percent."
It's not perfect—but then, it's the government. In my experience, government officials—particularly if they are up for election—aren't shy about speaking their minds. I hope that when our editorial team gives you an opportunity to speak up, you will do so, and lend your very important voices to these crucial issues.



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