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Government’s watchful eye has pharma on guard
January 2010
SHARING OPTIONS:
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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