House Energy and Commerce Committee Republican Leader Cathy McMorris Rodgers (R-WA), Subcommittee on Health Republican Leader Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Republican Leader Morgan Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf wanting answers on concerns about the increasing number of clinical trials being conducted solely or predominantly in China intended to support approvals for drugs to be marketed in the U.S.
LETTER EXCERPT: “In 2016, 23.8 percent of trials were initiated in the U.S. and just 12.5 percent were initiated in China. In 2017, trial initiations for the U.S. remained steady at 23.7 percent while initiations in China grew to 15.5 percent. However, in 2018, the situation dramatically changed. Trial initiations in the U.S. declined to 21.6 percent while initiations in China soared to 21.6 percent. In just two years, China went from having half the initiations of the U.S. to pulling even with us.
“This surge of clinical trials conducted in China is starting to manifest itself in FDA submissions. For example, in oncology drug development involving checkpoint inhibitors, FDA knows of at least 25 applications planned to be submitted or already submitted, that are based either solely or predominantly on clinical data from China. Many sponsors of trials performed in China began their clinical development in China after results of other checkpoint inhibitors in the disease were publicly available.”
The members raise specific concerns about:
- Clinical trials relying solely on enrollment of patients from a single country may not be representative of the U.S. patient population.
- Data quality because of the history of fabricated data in clinical trials conducted in China.
- How many biologics license applications or drug applications has FDA received that are based solely or predominantly on clinical trials from China?
- Prior to the pandemic, how many clinical trial sites in China were inspected by the FDA between January 1, 2017 and January 1, 2020? What were the outcomes of these inspections?
- How many clinical trial sites in China have been identified in applications to the FDA as being involved in data withdrawals?
- What kinds of efforts would need to be made to address data integrity issues found at such sites? Did any of these sites contribute a significant number of patients in international, multi-regional clinical trials submitted to regulatory agencies, particularly FDA?
LETTER EXCERPT: “In the past two decades, clinical research has become more global and complex and is increasingly being conducted in countries outside the United States. This increasing globalization presents FDA with many challenges, including the need to conduct more inspections of foreign sites. The Government Accountability Office (GAO) has already reported long-standing concerns regarding FDA’s ability to oversee the increasingly global drug manufacturing supply chain, an issue highlighted in GAO’s High Risk Series for the last 10 years. GAO last reported in 2019 that FDA’s total number of foreign drug manufacturing establishment inspections surpassed domestic totals in 2015, but that the agency faces persistent challenges related to identifying establishments subject to inspection and conducting inspections of foreign drug manufacturing establishments. However, prior GAO reports have not examined FDA’s ability to ensure that data from clinical trials and bioequivalence studies, including those conducted overseas, submitted as part of brand-name and generic drug applications are complete and accurate.”
“For that reason, we request that GAO conduct a review of FDA’s BIMO program as it relates to ensuring that the brand-name and generic drugs approved for marketing in the United States are safe and effective.”
The members ask Comptroller General Dodaro to review the BIMO program in order to ensure drugs approved in the United States are safe and effective, including:
- How inspections of clinical trial and bioequivalence study sites under the BIMO program help the agency assure the quality and integrity of data submitted to FDA in support of drug applications.
- The frequency of domestic and foreign inspections FDA conducts in support of the BIMO program.
- Any challenges FDA faces in carrying out the BIMO program domestically or overseas.
CLICK HERE to read the letter to FDA Commissioner Califf.
CLICK HERE to read the letter to Comptroller General Dodaro.
Original source can be found here.
