Aly Quoted on FDA Suspension of Overseas Pharmaceutical Site Inspections

The Center for Biosimilars

Intellectual Property Practice Group Co-Leader Imron Aly was quoted on how the U.S. Food and Drug Administration’s (FDA) decision to discontinue pharmaceutical site inspections overseas may worsen drug shortages, including biologics.

Imron said, “At a time when you’d rather have things expedited, having the FDA pull its inspections in India, in particular, is slowing things down.”

“I think we’re guaranteed drug shortages. We just don’t know how soon they’re going to be experienced here. From everything we’re hearing, there are going to be shortages within a matter of two months,” he said.

He added that the 26 active pharmaceutical ingredients that India is withholding are a subset of total pharmaceutical products shipped to the U.S., and so the FDA policy on inspections raises serious questions about whether the speed and efficiency of imports can be maintained.

“Inspections at the border have been rarely used, so Indian manufacturers have big concerns about how that’s going to happen,” Imron said. “We’re talking about crates of product that get imported here, and depending on what it is that the FDA is testing or how, there might be disputes about whether that crate of material is allowed to enter or not, when it normally wouldn’t have been an issue because the plant would have been cleared [via a site inspection in India]. So, there’s a lot of uncertainty about how this is going to impact the drugs that can get released from India.”

Read the full article here.

Continue Reading