Government’s watchful eye has pharma on guard

Beginning this issue, our Government Watch section will profile some of the latest legal, legislative, and regulatory developments in the pharma/biotech arenas. 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.

January3rd,2010
Amy Swinderman
Healthcare reform, alleged illegal marketing practices, drugsafety concerns, patent expirations, stem cell research—as a new decade dawns,the pharma and biotech industries are caught in the diverse crosshairs ofgovernment scrutiny, both in the United States and abroad. As these and otherpressing issues play out on the evening news, the editorial team at ddn is keeping our ears to the ground with a new contentdepartment.
Beginning this issue, our Government Watch section willprofile some of the latest legal, legislative, and regulatory developments inthe 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-bagof stories to sink our teeth into, and settled on a wide range of topics toshow our readers the various forms government scrutiny can take: federaloversight, state legislation, state regulation and international regulation, toname a few. Our writers—who are no strangers to reporting on such matters—wereeager to hit the ground running and delve into these topics, but were met withan all-too-familiar roadblock: Fear.
 
 
Figuring that our pharma sources would welcome the chance toopine on healthcare reform and other government scrutiny, we hoped to ask thequestions, sit back and let the answers flow. We soon learned, however, howcautious most companies are when it comes to such sensitive topics.
 
 
"While working on my story about the impact of healthcarereform on Big Pharma, I encountered more than a few companies that respectfullydeclined to comment on the issue," says our managing editor, David Hutton, whoonce covered legislation impacting the appraisal and valuation industries, bothon state and federal levels. "I certainly understand why companies might wantto decline to comment on legislative issues, but I firmly believe that it is intheir best interest to publicly state their positions on key issues to be apart of public discourse on proposals that affect their business, and theirbottom line."
 
 
Our writer Lori Lesko lucked out with her story on proposalto limit stem cell research funding in Missouri, but having earned her stripescovering hot topics for the real estate and settlement services industries, sheknows all too well how challenging it can be to get sources to open up aboutsensitive topics.
 
"With proposed or actual legislation, pharmas should want toweigh in," Lesko says. "Although ddnwill cover both sides of an issue, ddn would provide a forum for pharmas to make their case. Giving a 'nocomment' or refusing to take phone calls only weakens one's position and castsa shadow on one's credibility."
 
Speaking for myself, covering an investigation by theGovernment Accountability Office (GAO) was familiar ground, as I once tackled ahighly anticipated probe by the investigative arm of Congress into allegedillegal business practices by the title insurance industry. I recalled how, ayear after that explosive report rocked the industry, most of therecommendations the GAO made to resolve some of its concerns failed to see thelight of day—similar to what has happened at the U.S. Food and DrugAdministration (FDA), as you will read in the story.
 
 
I asked Marcia Crosse, director of healthcare at the GAOabout that. "Has the GAO ever measured to what extent its recommendations arefollowed or implemented?" I wanted to know.
 
"Oh, yes," Crosse responded. "We have an adoption rate ofabout 80 percent within four years. Our target rate of adoption is around 70 to75 percent."
 
It's not perfect—but then, it's the government. In myexperience, government officials—particularly if they are up forelection—aren't shy about speaking their minds. I hope that when our editorialteam gives you an opportunity to speak up, you will do so, and lend your veryimportant voices to these crucial issues.

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