Lawmakers Outraged Over Ineffectiveness of FDA’s Foreign Inspections Program

Federal lawmakers yesterday criticized the effectiveness of the FDA’s foreign inspections program, expressing outrage that the controversial anti-malaria drug hydroxychloroquine, which has been used to combat COVID-19, came from foreign plants that have never been inspected.

At a Senate Finance Committee hearing on the issue yesterday, Rep. Ron Wyden (D-Ore.) said Rick Bright, the HHS whistleblower who was the former director of the Biomedical Advanced Research and Development Authority (BARDA), reported that certain Pakistani plants supplying hydroxychloroquine to the U.S. had never been inspected by the FDA.

Bright also said that another source of the anti-malaria drugs was an Indian company that had been placed on the FDA’s import alert list, meaning that it was prohibited from importing them.

The FDA’s granting of an Emergency Use Authorization for hydroxychloroquine “threw open the door to tens of millions of pills … manufactured inside facilities in Pakistan and India that have either failed FDA inspections or never been inspected by the FDA at all,” Wyden said.

“The FDA has a heightened responsibility during the pandemic to maintain oversight of the supply chain,” Sen. Chuck Grassley (R-Iowa), chairman of the committee, said.

However, both domestic and foreign inspections are on hold because of the COVID-19 outbreak. That will continue for the time being, testified Judith McMeekin, the FDA Office of Regulatory Affairs’ associate commissioner for regulatory affairs, although a small number of “mission-critical” inspections will still occur.

A federal watchdog official also criticized the FDA’s foreign inspections program yesterday, citing a December 2019 Government Accountability Office (GAO) report that detailed the many problems.

The FDA does conduct surprise foreign inspections, but not many, and the exact number is not known, said Mary Denigan-Macauley, the GAO Health Care Director.  As of March 2019, the majority of the foreign drugmakers come from 10 countries, according to the GAO report.

Domestic inspections are almost always conducted without prior announcement, and companies that refuse inspections can be thwarted with an inspection warrant. Overseas, the FDA has the power to place firms on an import alert to block entry of their products at U.S. ports, but it cannot force them to let the investigators enter for inspection, the GAO said.

From 2012 to 2016, the FDA did increase the number of foreign inspections it conducted. In that time span, the FDA conducted more foreign inspections than domestic and a growing percent were in China and India, but the FDA still wasn’t doing enough unannounced inspections, the GAO official testified. The GAO also found that the FDA still provided up to three months advance notice for most foreign inspections. Many lawmakers view the advance notice as an opportunity for drugmakers to prepare for the visit and conceal manufacturing violations.

And despite calls for more inspections, both foreign and domestic inspections decreased by 10 percent and 13 percent respectively from fiscal 2016 through fiscal 2018, the report says (DID, Dec. 10, 2019).

The FDA will soon begin recording which of its foreign inspections are announced and unannounced, McMeekin said. She testified that midway through last year, the agency began a change in its IT system to accurately record whether inspections are announced or unannounced. A new data field for that purpose is being included in the agency’s inspection database and is scheduled to become active this month, she said. — James Miessler