Drugmakers asked to defend Chinese trials; reports

 Members of the China Select Committee in the US House have launched a national security investigation into a number of big pharma companies, asking for details of their use of clinical trial sites in China.

Letters to the companies – which include MSD and AbbVie according to Reuters and Bristol Myers Squibb according to Endpoints – are asking whether trials in China have involved sites linked to the Chinese military and particularly locations in Xinjiang, where there has been persecution of the mainly Muslim population of Uyghurs and other Turkic minorities.

The letters are signed by China Select Committee chair John Moolenaar (R-MI), who has asked the pharma companies whether they can guarantee that subjects recruited in the trials are "participating voluntarily and with informed consent." They ask for the companies to respond by 17th July.

"Through a combination of regulatory reforms, state subsidies, and (at best) questionable ethics, China has transformed itself into the cheapest and fastest place in the world to ​run early-stage human drug trials," the letters read. And while they do not accuse the drugmakers of wrongdoing, they suggest that running studies in China "exposes American ​companies to ethical and security ⁠risks."

The move is part of a concerted effort by lawmakers in the US to defend US biopharma interests at a time when China is emerging as a major player on the world stage, and increasingly a source of new medicines licensed by US companies and a location for clinical trials.

Last week, HHS said it will introduce a series of measures – under the Operation Trailblazer banner – to speed up drug research by reducing unnecessary delays to studies, increase participation in clinical research, and strengthen domestic research capacity.

Meanwhile, Moolenaar and Congresswoman Debbie Dingell (D-MI) earlier this month introduced the Biotech Investment National Security Act (BINSA), which would add biotechnology, and specifically pharmaceutical and biological product development, to the list of sectors subject to outbound investment screening.

That would make US companies' licensing deals, joint ventures, and equity investments involving Chinese organisations subject to review by the US Treasury Department. 

And, in May, Moolenaar wrote to Treasury Secretary Scott Bessent to call for restrictions on US investment in Chinese biotech companies, in the wake of BMS's $15.2 billion alliance with Hengrui Pharma, which he said involved the transfer of intellectual property to the Chinese company.

https://pharmaphorum.com/news/drugmakers-asked-defend-chinese-trials-reports