Senate Committee Reviews Foreign Drug Import Standards

The COVID-19 pandemic has brought into light supply chain issues all over the globe. At the heart of the issue is the pharmaceutical industry. Last week, the U.S. Senate Committee on Finance held a hearing on America’s dependence on foreign drug suppliers. The hearing, entitled “COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process,” included testimony from FDA members and generic drug manufacturers on the quality of imported drugs.

Senator Chuck Grassley (R-IA) opened the discussion by noting that the pharmaceutical supply chain is a security issue and the Committee on Finance has a responsibility to make sure that foreign-manufactured drugs “satisfy quality standards.” Grassley included that the FDA’s monitoring process needs to be stricter to force overseas manufacturers to maintain U.S. standards. Instead of conducting unannounced overseas inspections, the FDA generally gives a 12-week notice–enough time for overseas producers to “doctor up a facility to make sure it passes.”

“The end result is that the consumer is put at risk,” said Grassley. “Whether we are in the midst of a pandemic or not, these supply chain issues must be shored up and solved.”

However, while the majority of senators voiced support for Grassley’s proposal of more frequent unannounced inspections, FDA officials indicated that they were not likely to change their inspection process. Douglas Thockmorton of the Center for Drug Evaluation and Research testified that the FDA is adequately monitoring overseas drug production, including that the agency tests 100% of finished pharmaceutical ingredients and only 1% fail to meet quality standards.

COVID-19 Response

In response to the committee’s COVID-19 concerns, FDA officials highlighted various measures the agency has already taken to ensure safe drug imports. While they have indefinitely suspended routine foreign inspections, other measures they’re taking include:

  • Denying entry of unsafe products in to the U.S.;
  • Increasing physical examination at the U.S. border, which may include product sampling;
  • Reviewing a foreign manufacturer’s previous compliance history;
  • Utilizing information sharing from foreign governments through mutual recognition; and
  • Requesting records directly from manufacturers “in advance of or in lieu of” on-site drug inspections.

Officials offered no estimate of when they expect to reinstate routine inspections, noting that the public’s safety from the novel Coronavirus is their top concern.

Domestic Drug Manufacturing

Senators repeatedly mentioned the disruption in the global pharmaceutical supply chain, renewing attention in moving towards a more U.S.-based supply chain.

In his testimony, Civica President and CEO, Martin VanTrieste, said that “no single policy caused the exodus of pharmaceutical companies from the U.S., and it will take a multi-faceted approach–and a sustained commitment–to further diversify the supply chain and rebuild our domestic manufacturing capacity.”

VanTrieste listed possible solutions to the issue, including:

  • Creating an essential medicines list to set priorities for investments, policy and
    regulatory reviews
  • Improving transparency in sourcing, pricing and drug quality
  • Utilizing incentives to encourage U.S. investment
  • Committing government programs to prioritize purchase of U.S.-made goods
  • Enhancing the Strategic National Stockpile
  • Directly supporting U.S. manufacturing, and
  • Focusing on advanced manufacturing

The FDA plans to assess the situation as the Coronavirus pandemic evolves and possible supply chain issues arise.

Leave a Reply