The F.D.A. and Plan B--decision delayed by the FDA

[rodeodance]

http://www.nytimes.com/2005/01/25/opinion/25tues2.html?oref=login&pagewanted=print&position=

January 25, 2005
EDITORIAL

The F.D.A. and Plan B


....Under federal guidelines, the agency was supposed to issue a decision by Friday. Instead, the F.D.A. told the manufacturer, Barr Pharmaceuticals, that it was still conducting its review. The agency said it hoped to act soon, but set no specific date for action.

Yet, by now, there is no excuse for delay. No one questions that Plan B, which contains a concentrated dose of the progestin hormone found in daily birth control pills, is safe and effective. Moreover, by proposing to limit its availability over the counter to women over 16, Barr has removed as an issue the effect on adolescents, which the agency cited as a concern last May when, bowing to political pressure, it overrode scientific research and the overwhelming recommendation of two expert advisory panels to reject making Plan B available without a prescription to all women, regardless of age.....

[The Backlash Cometh]

1. Why does the FDA give them so much time to respond?

In July a stent manufacturer was given a warning letter, the stent manufacturer said that it would take 6 months to address the issues brought up in the warning. Why did they need to take so long? Were they waiting to see if people would die to validate the complaint?

It seems to drag its feet whenever it wants to.

[moobu2]

2. Faith based drug aproval. n/t