Drugs

FDA Study Shows Path to Uninterrupted Drug Supply

A study by University of Maryland School of Business risk management expert Clifford Rossi, funded by FDA and HHS, has identified a combination of factors that he says makes pharmaceutical production in the U.S. more attractive now than investing in either China or India. Rossi says that adopting advanced technologies such as continuous manufacturing (CM) further positions the U.S. to recapture a prominent position in pharmaceutical manufacturing.

A university media statement says the repositioning will require policy measures to effectively reduce U.S. consumer exposure in an industry currently with more than 100 FDA-listed shortages of basic drugs, as more than half of finished dosages are produced by manufacturers in foreign markets.

Rossi’s simulation analyses found that in the U.S., continuous manufacturing processes in nearly all scenarios were more economical than current batch processing. And under current U.S. corporate tax rates, U.S. batch and CM processing is more economical than the batch processing of drug products in China or India.

Rossi says there has been very little pharmaceutical investment in CM for several reasons, such as:

a lack of solid data on CM investment and operating costs that raises investment uncertainty;
potential management bias toward proven technology;
market factors that favor greater focus on research and development investment over manufacturing investment;
global regulatory uncertainty about product approval leveraging advanced manufacturing processes;
more stringent U.S. environmental regulations;
differential corporate tax rates between the U.S. and other countries; and
a large percentage of active pharmaceutical ingredient manufacturing outside the U.S. which can, due to supply chain logistics, affect finished dosage form end products.

“Crafting public policies to address such industry barriers and risks to domestic and advanced technology pharmaceutical manufacturing investment will be essential in ultimately stimulating such investment,” Rossi says.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome