Changes could reduce compounding regulatory burden

The US Government is making moves to address drug shortages—which could have consequences for Australia

Food and Drug Administration (FDA) Commissioner Scott Gottlieb has said his administration is looking to bolster the number of compounding pharmacies registering to become official ‘outsourcing facilities’.

These facilities would be called on to manufacture pharmaceuticals during times of commercial shortages.

“Appropriately compounded drugs can provide important alternatives for patients who need them,” said Mr Gottlieb  in late September.

“Our ultimate goal is to make it more feasible for compounding pharmacies to register as outsourcing facilities, enabling them to grow their businesses under a legally approved framework, and increase access to better quality compounded drugs in the process.”

Matthew Bellgrove, Director of National Custom Compounding on the Gold Coast, says the changes being implemented by the FDA will have ramifications that will be felt around the world.

The changes will remove some of the ‘regulatory burden’ from compounding pharmacies, he adds, suggesting that Australia should consider a similar move.

“It’s about future-proofing the medical industry against disruptions to medicine production,” says Mr Bellgrove.

“In Australia our Therapeutic Goods Administration regularly issues alerts listing medicines that are currently unavailable in the country. Tamiflu is a good example – we regularly run out of this important medication.

“You only have to look at the recent hurricane in Puerto Rico that brought the island’s huge pharmaceutical industry to a grinding halt, to realise the issue of future drug shortages is very real,” he says.

“The Puerto Rican industry supplies an estimated 10% of the Americas’ pharmaceuticals and some of these drugs are not manufactured anywhere else in the world.

“The US Government heavily invested money and resources to help the Puerto Rican industry rebuild and get back to operations quickly. We avoided any long-term drug shortages but it gave them a scare. Next time we may not be so lucky.”

Mr Bellgrove said he was hopeful Australia would follow America’s lead by encouraging  compounding pharmacies to shore up their operations in readiness to fill a potential need.

“The FDA is doing the sensible thing and swiftly introducing a back-up plan by encouraging compounding pharmacies to improve their services,” he says.

“A similar program in Australia could provide some security for our own medical sector and reduce the risk associated with reliance on overseas supply.”

Any changes to US drug manufacturing guidelines would be watched closely by the TGA,” says Mr Bellgrove.

“The United States is home to most of the big pharmaceutical companies, supplying a significant percentage of the world’s medications. Changes to the pharmaceutical industry over there will impact us here on the other side of the Pacific.

“We look forward to learning the finer detail of the FDA’s new regulations on compounding when they’re released in the coming months.”

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