New FDA designation could de-risk modernizing biopharma production tech
Designation would decouple review of manufacturing from product reviews
FDA officials and pharmaceutical industry executives have been pointing for years to vulnerabilities caused by opaque, fragile international supply chains, and to the benefits of encouraging investments in domestic advanced manufacturing capabilities. It took a devastating pandemic that threatened supplies of lifesaving drugs and highlighted the lack of domestic surge capacity for mAbs and antivirals to get Congress to wake up to the danger of relying on foreign suppliers and manufacturing plants.
The omnibus spending bill enacted in December included an advanced manufacturing technologies designation program that could help make the business case for investments in manufacturing platforms that will reduce the cost and increase the reliability of producing biotherapeutics. ...