The abrupt exit of the US FDA commissioner Scott Gottlieb after a nearly 2-year stint under the Trump administration throws Indian pharma into uncertainty on what would be the stance of the next commissioner on generics drug pricing, pace of approvals and regulatory inspections.
India, with the maximum US FDA-approved manufacturing sites outside the US and supplying 40 per cent of the generic formulations marketed in the US, is bound to feel the impact. The past two years have been a difficult phase for Indian pharma companies that export low-cost generic drugs to the US market. While the FDA under Gottlieb approved a record number of drugs, the pressure on drug pricing also peaked during this period. Several Indian drug firms had to recall medicines – especially those for treating hypertension – after a clamp down by the US regulator.
With the Trump government keen on bringing down drug prices and containing the opioid crisis in the US, it remains to be seen whom the administration chooses to helm the agency.
Gottlieb, a medical doctor, oversaw a tenure that saw the speeding up of the drug approval process, curbs on the use of e-cigarettes among the youth, and facilitating reduction in drug prices. He also played a role in initiating the generic drug user fee program. Data from Bloomberg show that the FDA approved a record 971 generic drugs in the fiscal year ended September 30. The total number stood at 937 in fiscal 2017 and 835 in fiscal 2016. Also, the FDA conducted 11 per cent fewer surveillance inspections of drug manufacturers in fiscal 2018 from a year ago level.
According to a Bloomberg Intelligence report, the sudden resignation of the FDA chief is not expected to slow down the agency’s aggressive efforts to speed up reviews of both new medicines and generic versions of the older, offpatent drugs that lack competition.
“Gottlieb had approved drugs faster, laid down a foundation to make the FDA more communicative that helped companies expedite drug launches. Now it goes back to the square one,” said Surjit Pal, a pharma analyst with brokerage firm Prabhudas Lilladher.
A slowdown in the approvals will be a negative for Indian pharma busy building pipeline of limited competition products to be launched in the US. Companies would also be apprehensive of an increase in FDA inspections and renewed pressure on drug pricing.