Mar 25, 2022

In the US, drug needs are met mostly by Active Pharmaceutical Ingredient (API) and drug manufacturers located overseas. The US Food and Drug Administration (FDA) is responsible for overseeing the safety, quality and effectiveness of all drugs manufactured domestically as well as overseas for drugs imported into the US. Due to the coronavirus pandemic, FDA paused its domestic and foreign manufacturing facility inspections significantly over the course of 2020 and 2021, creating a huge backlog. The agency introduced alternative tools to meet its requirements, such as online reviewing of records and data related to sampling and testing, FDA even began accepting inspections performed by European regulators as equivalent to FDA inspections. However, even with all these available alternatives, FDA was unable to complete its inspections, raising concerns regarding meeting its mandatory quality requirements.

A second challenge to meeting the FDA inspection requirements is the lack of personnel. FDA has had widely publicized challenges in hiring and retaining personnel, which also hinders its ability to carry out the FDA’s mission. If you don’t have people, and it is not easy to travel due to the COVID-19 public health emergency, it makes carrying out inspections of non-US establishments even more difficult.

Prior to the pandemic, foreign establishments received 12 weeks’ advance notice, giving manufacturers an opportunity to fix their problems well ahead of time, potentially concealing non-compliance issues. FDA inspectors also encountered challenges such as getting visas organized in time, language barriers and the need to organize translators, which cause even more delays, especially for inspections in China and India. In 2020 and 2021, FDA had postpone most of its foreign inspections, adding to that sizeable backlog, along with ongoing vacancy struggles.

Extending the risk of uncertainty

Government Accountability Office (GAO) Health Care Director Mary Denigan-Macauley recently testified on FDA’s inspection program before a US House of Representatives Appropriations subcommittee regarding GAO research into the agency’s foreign drug inspection program. Denigan-Macauley outlined the current challenges of the agency’s overseas inspection program, including staffing vacancies and inspection backlogs due to the pandemic. Denigan-Macauley acknowledged the agency has made some progress by increasing its overseas drug inspections.

Under newly proposed legislation in Congress, FDA would no longer provide advance notice to foreign companies of drug inspections. The Creating of Efficiency in Foreign Inspections Act specifically proposes to eliminate FDA’s practice of preannouncing foreign surveillance inspections. Sponsors of the legislation argue that the bill would create a more level playing field for US and foreign drug manufacturers, ultimately bolstering domestic drug supply chains as well as safety of drugs and APIs imported from overseas markets.

What is the Creating Efficiency in Foreign Inspections Act?

According to analysis from law firm Sidley Austin LLP, FDA’s authority to conduct inspections of drug manufacturers does not currently extend to foreign companies or facilities, often necessitating preannounced inspection arrangements in overseas markets. The Creating Efficiency in Foreign Inspections Act would eliminate preannouncements in many cases where FDA conducts surveillance inspections; other types of inspections such as preapproval, for-cause or pre-licensing processes would not be affected by the legislation.

The Sidley analysis further notes that FDA carried out a pilot program in 2014 and 2015 wherein advanced notices of inspection were not provided to drug manufacturers in China and India. Results of these unannounced facility audits included higher findings of misconduct and quality concerns. FDA officials have recently indicated plans by the agency to relaunch the program for Indian and Chinese manufacturers exporting to the US in 2022.

The need for “anytime audit” readiness

As FDA steps up its inspection activities in general and its unannounced inspections of some foreign manufacturers in particular, implications for industry should be carefully considered.

Along with US-based drug manufacturers, more and more overseas companies will need to become “anytime audit” ready—if the Creating Efficiency in Foreign Inspections Act becomes US law, unannounced FDA inspections could become a permanent program.

ComplianceWire for Life Sciences helps manufacturers automate the creation, delivery and reporting functions for role-based training, qualification and compliance programs. ComplianceWire also supports compliance to 21 CFR Part 11 and EU Annex 11 Validation requirements. We provide courses on regulatory audit and inspection readiness, as well as training on enhancing readiness among your people and processes.  

Vanita Khatter is Regulatory Services Regional Manager at UL ComplianceWire.

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  • Vanita Khatter