Clinical Trials In China Reboot BIOSECURE Act

By Louis Garguilo, Chief Editor, Outsourced Pharma

Clinical trials are not my beat, but the BIOSECURE Act targeting CDMOs sure is.

And now the congressional committee involved with putting that proposed legislation together has found something of perhaps more substance, and better substantiated, to add to the impetus of the Act.

According to a letter sent this month from the Chairman of The Select Committee on the CCP and other members of Congress, to FDA Commissioner Robert Califf, “For over a decade, it appears that U.S. biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s (PLA) …”

The letter is more detailed than the Act, and I believe is worth a read. I dare not offer any opinions at this point (but would love hearing your thoughts).

Moreover, this new salvo serves to bolster House Speaker Mike Johnson (R-La.), who in a fiery speech to the Hudson Institute in July, said he is 100% committed to bringing the BIOSECURE Act to a vote on the floor of the House of Representatives as early as this autumn.

This is more than here we go again. It’s here we are, with reinforcements.

Speaker Determined

Let’s start with that speech.

Johnson declared “we will vote on the BIOSECURE Act,” which narrowly defined is designed to stop federal contracts with Chinese biopharma-related companies, and includes WuXi Apptec.

I’d say it’s obvious Johnson had wind the letter from the select committee was about to drop.

Our goal, he said in escalation, is to have a significant package of China-related legislation signed into law by the end of this year in this Congress. He said it will feature “these priorities and many more.”

I won’t rehash details of the BIOSECURE Act here (my editorials on the subject are listed on OutsourcedPharma.com).

I’ll simply remind readers the Act was created in January, caused an uproar (both with those who saw it is unnecessary/unsubstantiated and those who backed punitive measures against China). Ultimately, it wasn’t inclulded this spring in the final version of the 2025 National Defense Authorization Act (NDAA).

Despite that respite, and perhaps in anticipation of more to come, the BIOSECURE Act has continued to harm WuXi Apptec. I’ve learned it has pushed U.S.-based biopharma companies to decide not to work in China.

But not only sponsors in the U.S.

Coincidentally, I was speaking this morning with Leonardo Sibilio, CEO of Biotech Academy in Rome, a biotechnology training organization for sponsors, CDMOs, and academia.

Unprompted (we were not on the subject), Sibilio informed me that, exacerbating the critical need for skilled workers in Europe, CDMOs specifically are frantically looking for ways to bolster their ranks in anticipation of a rash of new work from biotechs who were or might have considered working in China, or who are looking for second suppliers to mitigate risk.

Speaking of such ripples throughout the industry, in July, consultancy LEK published a survey that demonstrated impacts of the BIOSECURE Act.

According to the survey, the confidence of U.S.-based life science companies working with China-based firms was reduced by 30% to 50% in the months since the bill was introduced.

Some 68% of survey respondents are taking concrete actions, such as “diversifying suppliers.”

In retrospect, then, the headline in my most recent editorial –  Breaking: BIOSECURE Act Out. Long Live Wuxi Apptec?; June 2024) – written when we learned the Act failed to be included in the NDAA this year, was premature.

Indeed, the Act appears to be back (in one form or another), and more trouble is on the way for U.S.-China relations in the realm of our overall biopharmaceutical industry.

This time, specifically, there’s a bullseye on clinical trials.

A Clinic On China

The letter mentioned above from The Select Committee on the CCP to FDA Commissioner Robert Califf appears to me to start off in full accusatory mode, and seems to misrepresent the role of the FDA (my italics):

“As you know, the United States is engaged in a fierce competition with the People’s Republic of China (PRC) in biotechnology … As a key regulatory body interfacing with the biopharmaceutical ecosystem, the U.S. Food and Drug Administration (FDA) should play an active role in ensuring the United States remains ahead of the PRC in biotechnology …”

“Should” as in you are not playing that role adequately now, but is it actually the role of the FDA to actively work to ensure our industry remains ahead of that of other nations?

The plot, as they say thickens.

No Silk Road Ahead

We’ve certainly come a long way from:

• Including, with no facts backing flimsy allegations, a China-based CDMO – one with, from everything I can learn, a stellar reputation among the world’s bio and pharma customers – in the BIOSECURE Act;
• To condeming clinical trials performed by organizations as conducted in cahoots with sites affiliated with the Chinese military/government;
• To a pressure campaign to enlist the FDA in the dealings of both aforementioned activities.

As if outsourcing drug development and manufacturing wasn’t difficult enough.

Where do we go from here?

At the moment, the answer seems to hinge on what exactly happens in the U.S. Congress.

We should also be very interested in how FDA Commissioner Califf responds to the Select Committee. And how will those conducting clinical trials singled out in that letter to the FDA respond, if at all?

Call me naïve. I never would have expected this would get resurrected (or escalated) so quickly.

Many during challenging times like to say, “Things will get worse before they get better.”

Depending on your perspective, we could say they have just gotten appreciably worse.

We’ll have to keep an eye out for what the better might eventually look like.