The Times ODs at the FDA.

Media criticism.
Dec. 7 2004 7:09 PM

The Times ODs at the FDA

The root of all pharmaceutical evil, the paper finds, is an industry user fee.

(Continued from Page 1)

What about Vioxx? The FDA approved Vioxx in May 1999 and didn't document safety issues worthy of a ban until this year. That means the drug was on the market for about five years, roughly the same amount of time the fully funded safety cops took to blow the whistle on Seldane. If reduced budgets have slowed safety cops in their appointed rounds, the Times' Vioxx example offers no such vivid proof.

To be sure, the Times article cites anonymous "top agency officials" who dispute the idea that the user fee deal perverts the approval process. They tell the Times that the ratio of drugs withdrawn to drugs approved has remained steady for decades. But why aren't they speaking on the record? They're discussing ratios that should be publicly available, so what are they? While we're on the subject, how many drug labels were amended with stronger warnings before 1992, and how many after the 1992 user fee agreement went into effect?

Advertisement

The subdued hysteria of the Times article might lead you to believe that drug fast-tracking has resulted in an avalanche of new—and potentially dangerous—medicines. Not so. A Harvard-Michigan study from December 2003 found that millions in user fees from drug companies haven't sped the approval of new drugs any more than federal funding increases did in the past. The report also found no evidence that industry funding of fast-track approvals prejudices the process in favor of drug companies. Taking the wind out of the Times'huffing and puffing is this feature article published six years ago, in which GovExec.com critiqued the FDA pact with similar language. If the FDA user fee is news, it's old news.

The late Detroit News columnist Warren T. Brookes quarrelled with conservative journalists who believed the national press corps was liberal. In a 1989 Cato Institute lecture, he declared the press was biased but biased in favor of the state. Journalists, by and large, were "committed to the promotion of an ever more intrusive government presence in every aspect of our lives, except, of course, the press and the media themselves." The symbiotic relationship between the government and the media allowed the press to grow in power and importance whenever the government grew. The press corps' enduring commitment to the government's wisdom, he said, was "motivated by institutional self-interest." If Brooks were alive today, I suspect he'd use the Times story as a heavy-breathing example of his theory.

The FDA user fee may be a boon for drug consumers, a bane, or just a wash, but until the Times produces copy more worthy of a more outgoing headline—and a more declarative article—I remain agnostic.

******

Somewhere out there, somebody misses their Seldane, which the FDA ultimately drove off the market. Is that someone you? Drop me a line at pressbox@hotmail.com. (E-mail may be quoted by name unless the writer stipulates otherwise.)

Jack Shafer was Slate's editor at large. You can follow him on Twitter or email him at Shafer.Reuters@gmail.com.

TODAY IN SLATE

The World

The Budget Disaster that Sabotaged the WHO’s Response to Ebola

How Movies Like Contagion and Outbreak Distort Our Response to Real Epidemics

PowerPoint Is the Worst, and Now It’s the Latest Way to Hack Into Your Computer

Everything You Should Know About Today’s Eclipse

An Unscientific Ranking of Really, Really Old German Beers

Education

Welcome to 13th Grade!

Some high schools are offering a fifth year. That’s a great idea.

Culturebox

The Actual World

“Mount Thoreau” and the naming of things in the wilderness.

Want Kids to Delay Sex? Let Planned Parenthood Teach Them Sex Ed.

The Shooting Tragedies That Forged Canada’s Gun Politics

  News & Politics
Politics
Oct. 22 2014 9:42 PM Landslide Landrieu Can the Louisiana Democrat use the powers of incumbency to save herself one more time?
  Business
Continuously Operating
Oct. 22 2014 2:38 PM Crack Open an Old One A highly unscientific evaluation of Germany’s oldest breweries.
  Life
Lexicon Valley
Oct. 23 2014 10:30 AM Which Came First, the Word Chicken or the Word Egg?
  Double X
The XX Factor
Oct. 23 2014 11:33 AM Watch Little Princesses Curse for the Feminist Cause
  Slate Plus
Working
Oct. 23 2014 11:28 AM Slate’s Working Podcast: Episode 2 Transcript Read what David Plotz asked Dr. Meri Kolbrener about her workday.
  Arts
Brow Beat
Oct. 23 2014 11:34 AM Louis C.K. Crashes a Brad Pitt Interview on Between Two Ferns
  Technology
Future Tense
Oct. 22 2014 5:33 PM One More Reason Not to Use PowerPoint: It’s The Gateway for a Serious Windows Vulnerability
  Health & Science
Bad Astronomy
Oct. 23 2014 7:30 AM Our Solar System and Galaxy … Seen by an Astronaut
  Sports
Sports Nut
Oct. 20 2014 5:09 PM Keepaway, on Three. Ready—Break! On his record-breaking touchdown pass, Peyton Manning couldn’t even leave the celebration to chance.