FDA official accused of misleading Senators

June 11, 2020

An FDA official has been called out for downplaying America’s reliance on APIs from China and India.

The issue of how American pharma companies source their APIs had been in the Congressional spotlight long before the coronavirus pandemic. But concerns about the issue have intensified as supply chain disruptions and increased demand for critical drugs caused by the pandemic have contributed to drug shortages in a number of U.S. hospitals.

During a recent Senate hearing, Douglas Throckmorton, CDER’s deputy director for regulatory programs, was asked how much API America sources from China and India and he responded: “…for active pharmaceutical ingredients, the U.S. provides about 28 percent, China about 13 percent and India 18 percent.”

Although those figures reflect the percentages of API production facilities that export to the U.S., they do not reflect the volume of API on the American market. Estimates about the volume of API used to produce American drugs range from 60-80 percent — but the FDA also admits that it doesn’t know for sure what the exact number is because manufacturers are allowed to conceal whom they source API from for proprietary reasons.

After being asked by Bloomberg, an FDA spokesperson admitted that Throckmorton’s comments don’t “reflect actual production levels.”

As the FDA faces increasing pressure to improve its ability to adequately protect the supply and quality of generic drugs in America’s supply chain, the White House has been making moves to onshore more pharma manufacturing. In May, the Trump administration struck a $812 million deal with Virginia-based Phlow Corp. to manufacture APIs and finished dosage forms for many critical drugs. 

Read the full Bloomberg report.