Several groups representing the Pharma industry
recently filed a citizen's petition with the FDA opposing a new rule, slated to go into effect on March 21, that expands the evidence the agency can use to claim that a drug has been misbranded (promoted for an off-label or unapproved use).
The groups are crying foul over the pending rule because they perceive it to be fertile ground for regulatory over-reach. For example, if a manufacturer discovers that one of its products is being used off-label and adjusts production accordingly, then the FDA could use the company's internal documents describing its plans to scale up as evidence of a new intended (unapproved) use which would then bring regulatory action.
The FDA filed the rule in the Federal Register on January 9 while continuing to seek comments as it develops final guidance. The comment period is in effect until April 10.
Unsurprisingly, the Pharma industry wants more latitude in conveying "truthful, accurate and non-misleading" product information to clinicians. The FDA has maintained its long-held view that industry can't be trusted to do so which would endanger patie
http://seekingalpha.com/news/3251740-industry-groups-angling-softer-fda-rule-label-drug-promotion?app=1&uprof=37#email_link
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La tenemos negro por toda partes y los 300 del IBB parecen ya como que la muralla mejicana de Trump.
