Pharma manufacturing woes dog industry
[...] While many of these problems arise from quality control failures, according to Nicholson Price from Harvard Law School’s Petrie-Flom centre for health law policy, biotechnology and bioethics, this is not the only problem – regulatory constraints can prevent process improvements being made. The manufacturing process is approved as part of a new drug application (NDA), and thus many companies continue using the same processes for decades. Making changes post-launch is expensive, yet including new technology in an NDA risks delaying approval, reducing the time the product is on the market before its patent expires.
‘Regulatory agencies tend to be fairly risk averse, so if the FDA is not familiar with a new technology, however good, it is likely to delay approval,’ Price says. ‘The cost of making changes after approval is also significant. Yet continuing with the same procedure for 20 years runs the risk of things getting worse, rather than better, with equipment getting old. It is also hard to change methods that impact the drug specifications, which are set before the start of clinical trials.’ Regardless of whether these changes make any difference, manufacturing methods get locked in over time.
Price suggests the deadlock might be fixed if the FDA considered new manufacturing technology separately from the NDA process. ‘If the FDA could agree in advance it was a good idea, a company would be less worried about delays,’ he says. ‘I think this could go a long way to persuading companies to implement new technologies to improve manufacturing processes.’
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biotechnology fda intellectual property pharmaceuticals regulation research funding w. nicholson price ii