Proposed Bill Seeks to Eliminate Preannounced Foreign Drug Inspections

Under a newly introduced bill, the U.S. Food and Drug Administration (FDA) would no longer provide advance notice of foreign drug inspections. Historically, FDA has notified drug manufacturers located outside of the United States weeks or months in advance of a planned surveillance inspection, whereas FDA typically provides no advance notice to domestic drug manufacturers. The Senate Committee on Finance recently suggested that the delay between notice and inspection gives some foreign drug facilities sufficient time to conceal noncompliance at their facilities.¹

On January 13, 2022, Republican Sens. Mike Braun of Indiana and Joni Ernst of Iowa introduced the Creating Efficiency in Foreign Inspections Act, which proposes to eliminate FDA’s practice of preannouncing foreign surveillance inspections.² According to Ernst, the current practice puts U.S.-based drug manufacturers at a significant disadvantage to their foreign counterparts who receive a “heads up” notification prior to a facility inspection.³ Ernst believes this bill will level the playing field for U.S. companies.⁴ Ernst also hopes the bill will “help bring manufacturing back to the U.S.” and thus lead to a stronger domestic drug supply chain for important pharmaceutical products.⁵ 

The Senate Committee on Finance previously expressed concern that providing advance notice to foreign manufacturers has resulted in less-stringent inspections as well as foreign facilities’ not meeting appropriate quality and safety standards.⁶ This is of particular importance as the majority of global Active Pharmaceutical Ingredients (API) used in U.S. finished pharmaceuticals is manufactured in facilities outside of the U.S.⁷ FDA has maintained that the U.S. drug supply chain is among the safest in the world (80% to 90% of drug manufacturing facilities supplying the U.S. market are substantially compliant with good manufacturing practice requirements regardless of location) because the agency follows a risk-based approach to both domestic and foreign inspections and uses a variety of tools to encourage compliance such as untitled or warning letters, regulatory meetings, import alerts, injunctions, and seizures.⁸

The Creating Efficiency in Foreign Inspections Act

FDA’s general practice is to notify all manufacturers of preapproval and prelicense inspections and to notify most foreign drug facilities in advance of routine/surveillance inspections.⁹ These announcements, although not required under the Federal Food, Drug, and Cosmetic Act (FDCA), are intended to verify that the facility to be inspected is a drug manufacturer within FDA jurisdiction, ensure that appropriate records and personnel will be available, and allow sufficient time for logistics such as travel, access to facilities, and securing of visas.¹⁰ Additionally, because FDA’s inspectional authority under Section 704 (21 U.S.C. 374) does not apply to foreign facilities, preannouncement documents the foreign firm’s agreement to allow FDA inspection.¹¹

This bill proposes to amend Section 704 of the FDCA to allow FDA to inspect foreign drug manufacturers without advance notification unless notice is mandated by the host country or is required to protect public health. Notably, the requirements of the bill apply only to surveillance inspections and not to preapproval, prelicensure, or for-cause inspections. 

Looking Forward

From 2014-15, FDA ran a pilot program in India that eliminated extended advanced notice and instead relied on short notice or unannounced visits; FDA selected sites for the program that it believed to have significant issues.¹² The program exposed widespread misconduct, such as falsified quality records and a bird infestation at a manufacturing sterile site.¹³ Under the pilot program, “Official Action Indicated” findings increased by almost 60%.¹⁴ 

During a December 9, 2021, FDA virtual enforcement conference, Elizabeth Miller, Assistant Commissioner for Medical Products and Tobacco Operations in FDA’s Office of Regulatory Affairs (ORA), indicated FDA plans to restart this pilot program in India and expand it into China in early 2022.¹⁵ A House Appropriations Committee report accompanying the fiscal year 2021 omnibus bill confirmed this pilot and stated that “[t]he Committee is concerned that FDA’s drug inspection program continues to fall behind the levels needed to match the growth in foreign drug manufacturing facilities” and reiterated “that FDA’s regular practice of preannouncing foreign drug inspections well in advance of an inspection, raises serious questions about parity with domestic inspections, which are almost always unannounced.”¹⁶   

As it stands, the current version of the bill is solely Republican sponsored and is unlikely to pass the Democrat-controlled House and Senate during this congressional session. Nonetheless, Congress has been focused on the significant percentage of API and drug manufacturing occurring outside the U.S., and, depending on the outcome of the November elections, this bill or the concept of unannounced foreign drug inspections could resurface. Any legislation that includes provisions similar to the draft bill would have an important and immediate impact on foreign drug facilities. In theory, foreign facilities would be unable to plan for FDA surveillance inspections and, like domestic manufacturing facilities, would need to be “inspection ready” at all times. As demonstrated in the India pilot program, reducing or eliminating notice of FDA inspections makes it more difficult for drug manufacturing facilities in foreign countries to conceal problematic practices from U.S. regulators. Regardless, there would still be avenues for at least some advance notice to foreign companies. For example, some countries may notify local drug manufacturers that FDA investigators have applied for a visa and/or that they have entered the country. Thus, unannounced inspections would likely be more effective in countries such as India and China, where FDA already has field offices with investigators on site. 

¹See U.S. Senate Comm. on Finance, COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process at 14 (June 2, 2020) (available at https://www.finance.senate.gov/imo/media/doc/456402.pdf) [herein referred to as Hearing].
²Creating Efficiency in Foreign Facility Inspections Act, S.3509, 117th Cong. (Jan. 13, 2022) (available at https://www.congress.gov/bill/117th-congress/senate-bill/3509/text?q=%7B%22search%22%3A%5B%22Creating+Efficiency+in+Foreign+Inspections+Act%22%2C%22Creating%22%2C%22Efficiency%22%2C%22in%22%2C%22Foreign%22%2C%22Inspections%22%2C%22Act%22%5D%7D&r=1&s=1).
³See Joni Ernst, No More ‘Heads Up’ for Foreign Facilities: Ernst Wants to Level the Playing Field for American Producers (Jan. 20, 2022) (available at https://www.ernst.senate.gov/public/index.cfm/2022/1/no-more-heads-up-for-foreign-facilities-ernst-wants-to-level-the-playing-field-for-american-producers).
⁴Id.
⁵Id.
⁶See Sen. Charles E. Grassley, Ltr. to HHS Sec. Azar and Acting FDA Comm. Dr. Sharpless (Aug. 6, 2019) (available at https://www.finance.senate.gov/imo/media/doc/2019-08-06%20CEG%20to%20HHS%20FDA%20(Importation%20Plan).pdf) [herein referred to as Grassley Letter]; see Hearing at 14-15.
⁷Id.
⁸See FDA Comm. Dr. Hahn, Ltr. to Sen. Charles E. Grassley (Feb. 12, 2020) (available at https://www.finance.senate.gov/imo/media/doc/2019-3127%20RESPONSE.pdf); see Hearing at 52-55.
⁹See FDA Guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection at 3-4 (Oct. 2014); see Hearing at 14, 52.
¹⁰Id. 
¹¹See Hearing at 14.
¹²See Grassley Letter; see Hearing at 15.
¹³See Grassley Letter; see U.S. House Comm. on Energy and Commerce, Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program (Dec. 10, 2019) (available at https://www.govinfo.gov/content/pkg/CHRG-116hhrg44495/html/CHRG-116hhrg44495.htm); see Newsweek Magazine, Katherine Eban, Bottle X: Exposing Impurities in the Generic Drug Business (Jul. 2, 2019) (available at https://www.newsweek.com/2019/07/19/bottle-x-exposing-impurities-generic-drug-business-1446934.html).
¹⁴Id.
¹⁵See RAPS, J. Elgovitch, Unannounced FDA inspections in India, China to begin soon (Dec. 15, 2021).
¹⁶See H.R. Rep No. 116-445, at 86 (2020) (available at https://www.congress.gov/116/crpt/hrpt446/CRPT-116hrpt446.pdf).