U.S. House Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA) led two other E&C Committee members in calling on the Biden administration to explain why there are an increasing number of clinical trials being conducted solely or predominantly in China to support approvals for drugs that will be marketed in the United States.
In just two years, China has gone from having half the clinical trial initiations of the U.S. to pulling even with the U.S., according to two separate May 20 letters the lawmakers sent to Food and Drug Administration (FDA) Commissioner Robert Califf and U.S. Comptroller General Gene Dodaro in the U.S. Government Accountability Office (GAO).
“This surge of clinical trials conducted in China is starting to manifest itself in FDA submissions,” wrote Rep. McMorris Rodgers and E&C Committee members U.S. Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA) in their letters.
In the past two decades, the lawmakers wrote, clinical research has become more global and complex and is increasingly being conducted in countries outside the United States, presenting the FDA with many challenges, including the need to conduct more inspections of foreign sites.
“The 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,” they wrote Dodaro.
The current “East to West” movement of clinical data is not mainly about innovation, according to their letter to Califf, which points out that most drugs being discussed with the FDA are attempts to replicate known advances, also known as “me too” drugs, and do not fulfill an unmet medical need.
“These drugs are not biosimilar or generic drugs and, thus, are required to have complete clinical and non-clinical studies and manufacturing processes developed,” the members wrote. “These drugs cannot rely on information generated by the already-approved checkpoint inhibitors. As such, there is a lot of redundancy and expense for questionable benefit.”
Rep. McMorris Rodgers and her colleagues asked Califf to address several concerns and provide details on such as clinical trials that rely solely on enrollment of patients from a single country that are not representative of the U.S. patient population, and data quality, which China has a history of fabricating, according to their statement.
The members also requested that the GAO conduct a review of the FDA’s Bioresearch Monitoring Program (BIMO), a key component of the FDA’s mission to ensure that drugs are safe and effective before approval.