Regulatory and Financial Burdens Slow IR/MR Approvals, Says Expert

The scale-up and post approval changes (SUPAC) guidance whitepaper was originally written in 1992 by the Product Quality Research Institute (PQRI) – a body consisting of pharma and regulatory body representatives – and now an update is being produced to bring in the latest science and principles.

The aim is to cater for changes to immediate release (IR) and modified release (MR) products according to consultant Glenn Van Buskirk, who told Interphex attendees that the current guidelines don’t accommodate multiple changes easily and approvals are slow.

“We want to be effective in influencing regulatory change. We all know the FDA is very conservative and we all know the FDA is important throughout the world… so we know if we can influence the FDA we can have large influence on how our business operates in the future.”​

However, Van Buskirk – who serves as Managing Partner of Non-Clinical Drug Development Consulting Services - speculated on when the PQRI’s guidance would have any effect as a lot of cooperation amongst industry and regulators is needed with a number of possible setbacks:

“To do this we need data and the question to my mind is if we get phama companiesr to submit good quality data can we get some access to those? Will there be some knowledge to that which will be useful in stimulating further change?​

“It can only come from 2 places,”​ he continued to say. “Pharma company themselves doing good quality publications or from the FDA releasing information about the submissions they have received and the impact it has had on their criteria of relating stuff about release.”​

The FDA has guidelines in which it wishes to handle NDA, ANDA and SUPAC submissions within a period of time               yet Van Buskirk said that though the criteria is in place it often fails to meet them. He continued to have faith that such guidance as proposed by the PQRI would eventually help the FDA improve this.

There is the concern that pharma companies tend not to publish a lot of information, he added, or they are selective in what is released as competitiveness and the retaining of trade secrets still dictates this. Furthermore, though the FDA has a huge amount of data, certain requirements mean they are unable to release a lot of the useful information.

Financial Burden​

“What we are doing is increasing pharma costs in a day and age when there are huge cost pressure on us to do just the opposite,”​ said Van Buskirk, as such proposals would mean pharma companies would have to dedicate time, processing equipment, facility use and design and personnel to implement these measures.

“A lot of fingers have pointed at the fact that Government pressure on things like Medicare and Medicaid to push drug costs down… have actually created some of the shortages. They’ve squeezed the profit margins out so much that many pharma companies are finding it hard to compete and are going out of business. We have met the enemy and he is us.”​

Future trends ​

Van Buskirk said that the paper speculated on the “move towards batch processing to continuous processing”​ and how will that be handled by the pharmaceutical industry. “That’s a major paradigm shift for us to go from having a particular batch to maybe having something that runs for a week or two at a time.”

Though he was optimistic that “it will be a huge impact financially to a pharmaceutical company if you can do that well,”​ he did warn that if it wasn’t done “well there’ll be a product recall and then there will be an even bigger problem.”​