Gotta go: What Gottlieb achieved at the FDA
Reece Armstrong examines Scott Gottlieb's legacy on the FDA and what it means for pharmaceutical manufacturers.
The announcement of Scott Gottlieb’s departure from the FDA in March sent shockwaves throughout the pharmaceutical industry.
For a year in which the industry has faced uncertainty over Brexit, multiple major mergers and acquisitions, not to mention a number of innovative new developments targeting sepsis, AMR and genomics, Gottlieb’s forthcoming retirement is sure to be a cause of concern for manufacturers in the US.
A key figure for pharma, Gottlieb’s legacy will be grounded in his constant push towards innovation, highlighted by digital health initiatives and a recognition of the way new technologies can change current industry practices.
Take the regulator’s approach towards continuous manufacturing (CM), a technology which in recent years has been touted as an important tool in modernising the pharmaceutical industry.
Through the FDA’s efforts, early adopters of CM and other advanced manufacturing technologies will be assisted throughout the application process for products made using these methods.
But why is this important?
The adoption of new technology is what drives industries forward, but without reassurance from regulators, companies might not be so keen to become early adopters of potentially transformative processes.
The rise of CM for instance, while slow, is attuned to new drugs such as personalised medicines and gene therapies, both of which require different approaches to traditional batch manufacturing.
More importantly though, Gottlieb recognised that transparent regulation and policies for advanced manufacturing technologies are necessary if patients are the ultimate beneficiaries.
CM might be linked to reduced manufacturing footprints and more efficiency, but there’s potential that patients will also feel its benefits; specifically in relation to drug shortages.
Last year Gottlieb wrote that since quality issues are the main cause of drug shortages, the centralised nature of CM “allows for issues to be identified – and remedied – more quickly.”
“Advanced manufacturing techniques also allow for more flexible manufacturing capacity, which enables manufacturers to respond to drug shortages faster. With these systems, drug makers can more quickly adjust volumes based on product demand and therefore release product to the market more quickly,” Gottlieb wrote.
A penchant to push new technologies onto manufacturers is what regulatory bodies need if real change is to occur throughout the industry. With the high costs of developing new drugs, coupled with the doubt of any new product actually making it to market, it’s understandable that manufacturers might be unwilling to invest in methods that aren’t thoroughly tested.