The Food and Drug Administration has awarded a five-year $35 million grant to a nonprofit pharmaceutical think tank to figure out ways to improve drug safety and other measures toward ending the shortage crisis that’s enveloped the industry.
The National Institute for Pharmaceutical Technology and Education (NIPTE), a Chicago-based organization, is the recipient of the September grant that will be distributed to 11 universities to develop solutions to deter shortages of live-saving drugs by simplifying manufacturing and having fewer quality problems.
The drug shortages are occurring because most of these products are low volume and low profit margin and for-profit businesses are not really interested in continuing the manufacture of these drugs.” – Prabir Basu
FDA officials are working closely with industry, health care providers, and patients to prevent and mitigate shortages of “medically necessary” medicines. These shortages are coming under renewed scrutiny as the dire consequences of medication shortages to fight cancer and other diseases became known.
Increased outsourcing of drugs has led to dire prescription drug shortages because of a threat to overall quality of medications and resulting job losses in the U.S., according to NIPTE Executive Director Prabir Basu.
“We are thrilled to see the FDA’s commitment to invest in the science of pharmaceutical manufacturing,” Basu said. “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.”
NIPTE will partner with 11 universities in pharmaceutical science and engineering: Duquesne University, Illinois Institute of Technology, Purdue University, Rutgers University, University of Puerto Rico, University of Connecticut, University of Iowa, University of Kentucky, University of Maryland, University of Minnesota and University of Wisconsin.
Less than $1 million in grant money has been awarded so far.
“This grant is only one portion of the overall research effort that includes work done in FDA laboratories as well as individual projects contracted with universities,” said FDA spokesperson Lisa Kubaska.
“Some of this is already completed and available for industry to take advantage of the results. The five-year duration of the grant will fund many projects, some of which will be completed in about one year,” she added.
The FDA grants will be used to support programs to rectify these problems by creating ways to reduce the time to market and improving small-batch productions.
Basu’s biggest hope is that other federal agencies will allocate federal spending toward manufacturing research to improve health care in the U.S.
“The drug shortages are occurring because most of these products are low volume and low profit margin and for-profit businesses are not really interested in continuing the manufacture of these drugs,” Basu said.