A CHANGE OF GUARD could slow down
approvals, lead to more inspections and increase pressure on drug pricing
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% 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% 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.
