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Pallone Bill Would Facilitate Change in Pharma Production

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Experts say drug manufacturing in the US is in need of an overhaul, and New Jersey Congressman Frank Pallone has had a bill passed by the House that would help do just that.

Rutgers University has been leading research in this area, trying to get drug makers to make medications using a continuous process rather than making huge batches of a drug. The technology allows product quality to be precisely controlled, reduces challenges in scaling up production, can more readily produce ranges of drug strengths and doses, and requires less physical space.   

Fernando Muzzio, professor of chemical engineering at Rutgers, said the industry has been resistant to this change, afraid of regulatory problems -- but he said that turned out not to be the case.

“They (companies) were afraid that the FDA wasn’t going to let them (change processes), so we talked to FDA, we went and talked to FDA, and FDA was happy,” he said, “FDA was very supportive, FDA immediately said this is what we want, and this is better and yes we want this.”

Muzzio said the problem is that the industry needs education in this area, which the Pallone legislation would help finance. “The Pallone legislation would put the money in place so that we can do what is the critical next step,” he said, “which is for us to be able to teach the US-based generic pharmaceutical industry how to use these technologies.”

He said changing the way drugs are manufactured would speed up drug development during the pandemic. “If I’m not sure which dose I need to use,” said Muzzio, “I can make 20 or 30 different versions of the product and then I make those available to the clinicians to try with patients.”

The continuous process, said Muzzio, results in fewer errors in production. “You’re proposing a manufacturing method where you are using sensors to monitor what is happening every second ... the probability of error is much lower,” he said.

And a change in process, Muzzio said, might also help bring more drug production back into the US. He said about 15 or 20 years ago production began to shift overseas because of lower labor costs. “The future is advanced manufacturing,” he said. “It’s a very important question for our country and our state. Will the US be able to take and retain the lead in making drugs using these new methods?”