FDA awards $35m to improve US drug production
Over the next five years the National Institute for Pharmaceutical Technology and Education (NIPTE) will receive up to $35m from the US Food and Drug Administration (FDA) to improve manufacturing. By increasing the efficiency of drug production NIPTE hopes to make the US more competitive.
“Development and manufacturing costs can be reduced, quality of our drugs can be improved, and outsourcing trends can be reversed by developing science-based standards for drug development and manufacturing”, Prabir Basu, executive director of NIPTE, said.
Goals of the project include promotion of continuous manufacturing and improvement of small batch production. Making gains in these and other areas could encourage US biopharm to invest in local, in-house capacity by reducing cost and energy use while cutting time to market.
Basu said: “Outsourcing of drugs and drug intermediates are increasing at an alarming rate, potentially threatening overall quality of our drugs accompanied by huge job losses in this country.”
Regaining the edge
Increasing innovation and efficiency is often cited as a way for the US to regain an edge over low-cost manufacturing regions and some have called for governmental support to stimulate improvements.
“Governments at all levels should make investments in infrastructure and facilitate its expansion to encourage research and development, production and academic clustering”, a 2010 National Association of Manufacturers report said.
The FDA has supported innovation with grants to improve biopharm production and understanding of nanoparticles. NIPTE and the FDA worked together to make an excipient information website before trying to improve US biopharm production.
“Progress in this area will mean safer, more efficient, and less costly drug production here in the US, and we are looking forward to NIPTE's findings”, Helen Winkle, director, FDA Office of Pharmaceutical Sciences, said.
