US budget boost for FDA and generic competition

President Trump’s 2019 Budget request​ published this week includes an extra $473m of appropriation for the US Food and Drug Administration (FDA).

Advocacy group The Alliance for a Stronger FDA described this proposal as the largest ever increase for the regulator and, according to executive director Ladd Wiley, “represents an enormous vote of confidence in FDA.”​

180-day exclusivity for generic drugs​

The budget also looks to tackle high drug pricing in the US through a series of measures, including by giving the FDA greater ability to bring generics to market faster by incentivizing more competition among manufacturers.

“The Budget proposes to ensure that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period,”​ the document states.

“When a first-to-file generic application is not yet approved due to deficiencies, FDA would be able to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock, rather than waiting an indefinite period for the first-to-file applicant to fix the deficiencies in its application.​

“Triggering the start of the 180 day-exclusivity period for first-to-file applicants who “park” their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers.”​

According to the budget document, this will save $118m in 2019 and $1.8bn over the next decade.

This supports draft guidance​ published last month by the FDA addressing questions around the current rules on generic drug exclusivity, commonly known as 180-day exclusivity for generic drug products.

Other requests in the budget include $5bn over the next five years to help combat the opioid epidemic, which saw around 64,000 people die from drug overdoses in 2016.