In a bid to loosen off-label communications, a congressman quietly introduced a bill late last month that would expand the ability of drug makers to discuss unapproved uses of their medicines with doctors.
The legislation, which was proposed by Representative Morgan Griffith (R-Va.), addresses a controversial, if technical term called “intended use.” The Food and Drug Administration maintains that discussion of an unapproved, or off-label use, creates a new intended use for which a drug maker must have regulatory approval.
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FDA is in pockets of pharma. Let’s face it. That is reality. No wonder prices of drugs sky rocket as soon FDA gets a peak. Recently they have issued about 100 page guideline for Pizza.
If they could come up with guidelines on when and how to use the bathrooms, they would. That would be a horror story.