The 21st Century Cures bill includes language proposing modifications to FDAMA 114. This may be a good thing as the brevity of the original language left some important questions regarding the creation and use of FDAMA 114 pieces. The House passed the bill in July, it goes to the Congress and is expected on the President’s desk by the end of 2015.
There are 3 fundamental points in the bill:
1 – Including “payer” as a target recipient of a FDAMA 114 piece. This is a fairly minor point, “payer” seemed to be implied in the initial language.
2 – Changing “directly relates” to “relates” regarding the evidence. This is a much needed clarification. No one really knew what “directly related” meant. The new language suggests you need to be clear regarding any differences between the evidence being shared in a FDAMA 114 piece and the drug’s label, using a “conspicuous and prominent statement”.
3 – Clarification of what is health care economic information. This one is interesting, though still somewhat ambiguous. Are they really intending to allow the promotion of clinical claims at the lower competent and reliable standard, within the context of a FDAMA 114 promotional piece? This would be a dramatic change for the FDA.
All in all, the 21st Century Cures bill appears to be a good thing for the pharmaceutical industry, though more clarity is still needed for point #3.
