Citing prescription price reduction efforts, FDA releases new guidance for generic drug makers


The Trump administration continued its series of moves this week aimed at tackling high prescription drug prices as it released a batch of new guidance on Friday aimed at helping generic drug makers. 

The goal, the administration said, was to offer scientific and regulatory clarity, specifically for drugmakers seeking to create abuse-deterrent opioids, as well as hard-to-copy complex generics, where there is often little to no competition despite patents and exclusivities that have expired.

“Generic drugs increase price competition and provide access to more affordable options for consumers,” said FDA Commissioner Scott Gottlieb, M.D.

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As an example, he pointed to drug-device combination products such as those in which drugs are incorporated into nasal aerosol devices.

RELATED: Gottlieb: FDA to kick-start plans to increase competition in drug markets this week

The FDA also announced it was updating guidance on the development of generic copies of abuse-deterrent formulations of opioid pain drugs.

“The widespread availability of generic abuse-deterrent opioids may help providers and payers to switch to these alternatives,” Gottlieb said. “These updated guidances will make the process for developing low cost, generic versions of the abuse-deterrent products more predictable and practical.” 

RELATED: FDA to form work group to examine drug importation as a solution to high costs



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