The Food and Drug Administration Safety and Innovation Act calls for the reauthorization of user fees for drugs and devices – PDUFA V and MUDFA III – both of which will expire in September, as well as for the introduction of fee schemes for generic and biosimilar drugs – GDUFA and BsUFA.
If approved, a proportion of the fees paid by drug and device makers under these programmes will be used to fund the agency’s inspection of manufacturing facilities.
However, the bill goes further with section 707 calling for the Secretary of Homeland Security to be granted the power to “bar a drug from entering the United States if the product is manufactured in a facility that refused to permit HHS inspections.”
Senator Mike Enzi (R-Wyo) stressed the importance of this measure in his address to the upper house yesterday , citing recent high-profile problems with products sourced outside the US to support his argument.
“The bill will also modernise how FDA inspection foreign facilities to better account for the global nature of drug manufacturing“ he said adding that “it will allow FDA to prioritize and target riskier overseas facilities, which will help prevent the recurrence of problems with drugs like heparin.”
To facilitate this approach the bill mandates the US Department of Health and Human Services (HHS) to set up a unique facility identifier system and database and “guarantee the accuracy and coordination of FDA databases in an effort to identify and inform risk-based inspections.”
Another provision likely to impact pharmaceutical manufacturers is section 706, which makes drugmakers responsible for both auditing their active pharmaceutical ingredient (API) suppliers and submitting the results of those assessments in a timely manner.
The Senate began voting on the bill yesterday and is expected to reach a final decision later this week.