FDA Commissioner Raises Concerns About US Pharma Lagging Behind China In Drug Development

Marty Makary, in an interview with CNBC, further called for reforms that could streamline the process for starting trials on new treatments.

• Makary urged the Trump administration to partner with the pharmaceutical industry. 
• The senior official is of the opinion that there exists multiple bottlenecks that have caused the U.S. to lag behind. 
• As per CNBC, China now conducts more clinical trials than the U.S. and accounts for nearly a third of new global drug approvals.

The U.S. Food and Drug Administration (FDA) Commissioner Marty Makary on Wednesday reportedly warned that the country is falling behind its Asian rival China in drug development.

Makary, in an interview with CNBC, further called for reforms that could streamline the process for starting trials on new treatments.

The senior official is of the opinion that there exists multiple bottlenecks that have caused the U.S. to lag behind. Makary recommended that the Trump administration partner with the pharmaceutical industry “to help them deliver more cures and meaningful treatments for the American public.”

As per CNBC, China now conducts more clinical trials than the U.S. and accounts for nearly a third of new global drug approvals.

FDA’s Efforts

Last year, the FDA initiated a program called the Commissioner's National Priority Voucher program in a bid to expedite the review of certain drug applications. The program aims to reduce FDA assessment time to one to two months from the standard 10 to 12 months.

So far, over 15 drugs from various pharma companies have been awarded the voucher and while one has been approved, another has also been rejected.

Earlier this month, FDA refused to approve Disc Medicine’s bitopertin oral tablets for the treatment of Erythropoietic Protoporphyria despite tapping the drug for fast review.

However, the agency approved Augmentin XR manufactured by USAntibiotics in December after granting it the voucher.  

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around iShares U.S. Pharmaceuticals ETF (IHE) stayed within the ‘neutral’ territory coupled with ‘normal’ message volume.

The ETF closed marginally in the red on Wednesday but has gained about 29% over the past 12 months.

Meanwhile, Invesco Pharmaceuticals ETF (PJP) and State Street SPDR S&P Pharmaceuticals ETF (XPH) added 26% and 27%, respectively. 

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