FDA’s “Off-Label Rule” under Attack
Medical device and drug manufacturers familiar with the FDA approval process know well the “intended use” statement. Any approval given by the FDA is for the intended use stated and supported in the 510(k) or other premarket approval submission. This intended use is then translated onto the device or drug label. It limits what manufactuers can market their device. It’s called the “off-label rule” and the LA Times is reporting its being challenged by drug makers.
Now some drug makers are pushing back in court, arguing that the FDA’s marketing limits violate their 1st Amendment rights. The government’s approach to off-label uses has some weaknesses that deter research and make it harder for doctors to learn about new, effective treatments, but simply throwing out the restraints on off-label marketing would only encourage a less formal and rigorous process for drugs and devices entering the market.
To read more from the LA Times click here. Until this challenge is resolved device and drug manufactures still must head and remember the off-label rule. Any new intended use or change in the device or drug requires a modification of the 510(k) or PMA. The FDA uses a range of criteria in determining when a modification is required, this includes changes in intended use as well as changes in materials and technology. It’s important to consult with legal counsel before going off-label.
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