USFDA to modernise generic review with $37.6m funding
The US Food and Drug Administration (FDA) is planning to use new budget funding to modernise generic drug review and promote more widespread use of generics.
In a blog post published yesterday, June 18, the FDA’s managing director Scott Gottlieb revealed the details of the two new initiatives.
US President Donald Trump’s requested budget for 2019 included $37.6 million to fund the initiatives, said Gottlieb.
The FDA’s first scheme will create a new review platform to modernise generic drug review from a text-based to a data-based assessment.
According to the agency, the new platform will enable a structured review that will “make the application review process more efficient and allow deficiencies to be spotted earlier”.
In turn, this will allow the FDA to provide earlier feedback to generic drug makers which will help reduce multiple cycles of application review.
“Going through multiple review cycles is one of the primary reasons why the approval of generic drug applications is sometimes delayed many years,” explained Gottlieb.
The FDA’s second initiative is aimed at promoting use of existing generics by looking for ways to keep generic drug labelling up to date with the latest information about each medicine’s risks and benefits.
“Generic drugs are generally required to have the same labelling as the brand drug they reference. And the burden to update the labelling with new safety and effectiveness information is typically born by the brand company,” said Gottlieb.
But when branded reference drug companies withdraw their marketing applications, they also stop updating their labelling, resulting in the loss of a key mechanism that the FDA relies on to update generic labelling.
Initially, the FDA will focus on oncology products.
Gottlieb added: “Consistent with our current authorities, which allow for certain types of labelling changes to continue to be made for generic drugs after the brand drug is withdrawn, this budget request will provide the funding to allow the FDA to assume more responsibility to help bring these drug labels up to date.”
The FDA announced its intention to target the barriers to generic drug competition in June last year.
Earlier this month, Gottlieb spoke to attendees at the 2018 BIO International Convention about the office’s modernisation efforts.
He also defended the FDA’s decision to make public a list of companies that have potentially been blocking access to the samples of their branded products.
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