Friday, April 15, 2005
Congressional fashionistas
[Anne Applebaum, "The Drug Approval Pendulum," The Washington Post, 13 April 2005.]
What a difference a decade makes. As columnist Anne Applebaum points out in this recent column, all of the prescription drug scares of late clash with the push for new drugs fast that was the clarion call of legislators in the recent past:
Most of the time, when we use the word "fashion," we are talking about hemlines, or footwear, or shades of nail polish. But there are also intellectual fashions, literary fashions, political fashions. In fact, almost any sphere of human activity is subject to abrupt shifts in conventional wisdom: Even the arcane world of pharmaceutical regulation is afflicted by highly emotional mood swings.
To see what I mean, think back to the early 1990s.
House Speaker Newt Gingrich (R-Ga.) called the FDA the "leading job killer in America." House Commerce Committee Chairman Joe Barton (R-Tex.) declared that the FDA should stop ruling on the efficacy of drugs at all and stick to measuring whether they are "safe, pure, and packaged safely."
Thanks to sentiments such as these, Congress in 1992 passed the Prescription Drug User Fee Act. Among other things, the new law pressured drug regulators to speed up their review procedures, even rushing some life-saving drugs through the approval process in a mere six months. The law was reauthorized. Twice.
For a short time, harmony reigned. But then the pendulum began to swing, the winds of fashion began to blow in a different direction, and the FDA, once a bureaucratic monolith bearing down on the brave new world of pharmaceutical research, somehow managed to become the FDA, a bureaucratic castrato cozying up to the greedy pharmaceutical companies.
Clearly, caution is now "in." Patients' rights are "out." Risk-averseness is "in." Hot new research is "out." "There is no doubt that there has been a cultural change," the director of the FDA's Office of New Drugs told a reporter last week. And there is no doubt that Congress, along with everybody else, sincerely believes that the change is, will be, and should be permanent. How little we know of fashion!
[Anne Applebaum, "The Drug Approval Pendulum," The Washington Post, 13 April 2005.]
What a difference a decade makes. As columnist Anne Applebaum points out in this recent column, all of the prescription drug scares of late clash with the push for new drugs fast that was the clarion call of legislators in the recent past:
Most of the time, when we use the word "fashion," we are talking about hemlines, or footwear, or shades of nail polish. But there are also intellectual fashions, literary fashions, political fashions. In fact, almost any sphere of human activity is subject to abrupt shifts in conventional wisdom: Even the arcane world of pharmaceutical regulation is afflicted by highly emotional mood swings.
To see what I mean, think back to the early 1990s.
House Speaker Newt Gingrich (R-Ga.) called the FDA the "leading job killer in America." House Commerce Committee Chairman Joe Barton (R-Tex.) declared that the FDA should stop ruling on the efficacy of drugs at all and stick to measuring whether they are "safe, pure, and packaged safely."
Thanks to sentiments such as these, Congress in 1992 passed the Prescription Drug User Fee Act. Among other things, the new law pressured drug regulators to speed up their review procedures, even rushing some life-saving drugs through the approval process in a mere six months. The law was reauthorized. Twice.
For a short time, harmony reigned. But then the pendulum began to swing, the winds of fashion began to blow in a different direction, and the FDA, once a bureaucratic monolith bearing down on the brave new world of pharmaceutical research, somehow managed to become the FDA, a bureaucratic castrato cozying up to the greedy pharmaceutical companies.
Clearly, caution is now "in." Patients' rights are "out." Risk-averseness is "in." Hot new research is "out." "There is no doubt that there has been a cultural change," the director of the FDA's Office of New Drugs told a reporter last week. And there is no doubt that Congress, along with everybody else, sincerely believes that the change is, will be, and should be permanent. How little we know of fashion!
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