Aly Quoted on FDA Suspension of Overseas Pharmaceutical Site Inspections

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Aly Quoted on FDA Suspension of Overseas Pharmaceutical Site Inspections

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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 impact drug shortages.

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.”

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.

“I think we’re guaranteed drug shortages. We just don’t know how soon they’re going to be experienced here,” he said.

The FDA announced it will use alternative measures in lieu of a physical inspection, but it is not clear what will be affected.  As a result, Imron noted that “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.