As we prepare to think "turkey" -- let's first talk "chicken."
As in "Chicken Little."
I share this because, having just landed in Mexico City for a conference on HTA and pharmacoeconomics, I can attest to the fact that the sky is not falling – notwithstanding a story in today’s Washington Post that the FDA is teetering on the brink.
Consider the opening paragraph:
“Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”
First of all, the agency already has some very high caliber leadership – but a new Commissioner with vision, guts and communication skills will absolutely make things better. The FDA is a very hierarchical agency. And it’s very true that more money, personnel and technology are must haves. Particularly technology.
But folks, as Pollyanna-ish as it may sound – the agency that parlor game pundits, some of our elected officials and so-called “watchdog groups” are bemoaning as broken – is actually working pretty well considering withering media attacks, internal score-settling and general hand-wringing by people who mostly have no idea what they’re talking about.
And some who do and should know better.
I am surprised by the comments of my former colleague Bill Hubbard who is quoted in the Post as saying, "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us."
If that’s true today, then it must have been true when Bill and I were at Parklawn together. And it wasn’t true then. Bill wants the best for the agency – but tacking to the political winds is bad strategy.
"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."
It’s important to read what Dr. Kessler said – that there’s a general “perception” – that’s a lot different from it being true. But minus a smart and robust communications strategy – perception becomes reality. And the FDA has been minus a smart and robust communications strategy for too long.
And then there are those with personal agendas.
"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.
Funny the article should quote David Ross – who has a chip on his shoulder the size of Gibralter. It’s kind of like asking Hillary Clinton to write a job recommendation for Monica Lewinsky. It’s also poor reporting that Ross’ conflicts weren’t noted.
Sloppy journalism and bad editing.
And then there are those who point out how well the FDA was run when they were running it:
"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.
Let’s face it -- Jane will not go down in history as one of the great FDA Commissioners. And shame on her for saying the agency isn’t using science, first, last and always as it’s decision-making compass.
The article makes one excellent point that needs to be repeated and repeated and repeated, “While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.”
That’s change we can believe in – lots of change.
And, according to Mark McClellan – already considered by many to be one of the FDA’s Hall of Fame Commissioners -- "There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources. The most important thing is overall effective leadership that leads in a way that establishes public trust."
Amen.
And Happy Thanksgiving.
As in "Chicken Little."
I share this because, having just landed in Mexico City for a conference on HTA and pharmacoeconomics, I can attest to the fact that the sky is not falling – notwithstanding a story in today’s Washington Post that the FDA is teetering on the brink.
Consider the opening paragraph:
“Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.”
First of all, the agency already has some very high caliber leadership – but a new Commissioner with vision, guts and communication skills will absolutely make things better. The FDA is a very hierarchical agency. And it’s very true that more money, personnel and technology are must haves. Particularly technology.
But folks, as Pollyanna-ish as it may sound – the agency that parlor game pundits, some of our elected officials and so-called “watchdog groups” are bemoaning as broken – is actually working pretty well considering withering media attacks, internal score-settling and general hand-wringing by people who mostly have no idea what they’re talking about.
And some who do and should know better.
I am surprised by the comments of my former colleague Bill Hubbard who is quoted in the Post as saying, "FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us."
If that’s true today, then it must have been true when Bill and I were at Parklawn together. And it wasn’t true then. Bill wants the best for the agency – but tacking to the political winds is bad strategy.
"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."
It’s important to read what Dr. Kessler said – that there’s a general “perception” – that’s a lot different from it being true. But minus a smart and robust communications strategy – perception becomes reality. And the FDA has been minus a smart and robust communications strategy for too long.
And then there are those with personal agendas.
"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.
Funny the article should quote David Ross – who has a chip on his shoulder the size of Gibralter. It’s kind of like asking Hillary Clinton to write a job recommendation for Monica Lewinsky. It’s also poor reporting that Ross’ conflicts weren’t noted.
Sloppy journalism and bad editing.
And then there are those who point out how well the FDA was run when they were running it:
"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.
Let’s face it -- Jane will not go down in history as one of the great FDA Commissioners. And shame on her for saying the agency isn’t using science, first, last and always as it’s decision-making compass.
The article makes one excellent point that needs to be repeated and repeated and repeated, “While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.”
That’s change we can believe in – lots of change.
And, according to Mark McClellan – already considered by many to be one of the FDA’s Hall of Fame Commissioners -- "There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources. The most important thing is overall effective leadership that leads in a way that establishes public trust."
Amen.
And Happy Thanksgiving.
