The Food and Drug Administration (FDA) is finally showing hints
of moving in the right direction when it comes to protecting the
public from harmful drugs. In fact, the agency is touting the "stop
misleading the public; tell the truth" commandment more often
when it spots misleading advertisements for prescription drugs.
Yet despite the FDA's progress, several lawmakers, consumer advocates
and former FDA officials argue the agency still needs to go that
extra mile if it hopes to effectively police drug marketing.
Step it Up!
For starters, it comes down to the numbers: The agency's drug-marketing
enforcement office -- responsible for monitoring more than 30,000
print and broadcast ads, sales brochures to doctors and company
Web sites -- employs a staff of only 40 professionals.
And, while the FDA cited 13 drug pitches this year that disobeyed
the marketing rules, the pace of enforcement is lagging behind the
historical level; in 2000 the agency cited a whopping 79 pitches.
Some of the drugs that have attracted the most citations from the
FDA include:
- Vioxx
- Lipitor
- Claritin
- Celebrex
What does the FDA have to say for its actions ... or lack thereof?
The agency is aware its numbers have fallen, but claims it's biting
down hard on the campaigns it does cite. But is that really the
case?
Too Little, Too Late
For one thing, drug makers have certainly learned to push the edge
of the envelope. FDA enforcement records reveal drug makers have:
- Buried risk information with moviemaking skill.
- "Stretched the truth" about competing products.
- Misled patients suffering from cancer and toenail infections
alike.
- Pitched antidepressants to people who the FDA said didn't need
them.
But, according to the director of Public Citizen's health research
group, the FDA only encourages bad behavior by handing out weak
punishments; at times the FDA didn't act until after the fouled
promotions ceased.
Worse, the FDA has been branded with the inability to possess the
power to fine companies for misleading promotions and instead relies
on two kinds of letters to do the job: The first letter is a less
serious one, equivalent to a slap on the wrist; the second letter,
however, stops offending pitches and requests corrective action.
Bottom line: The FDA needs to come down harder on offenders to
get out the message that violations lead to expensive consequences
and will not be tolerated.
USA
Today May 31, 2005
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