U.S. passes 'competition' bill aimed at cracking down on APIs, drugs and medical devices from China

On March 28, U.
S.
time, the U.
S.
Senate passed a "competition" (COMPETES) bill with a significant advantage of 68 votes to 28.
The focus of this bill in the pharmaceutical and manufacturing industries is mainly on the protection of supply chains, especially is to reduce dependence on manufacturers such as China
.

The bill has previously been supported by US President Biden and passed in the US House of Representatives, but the specific details still need to be finalized by the House and Senate

The bill specifically states that it will join the U.
S.
Department of Justice, the Federal Trade Commission and other federal agencies to investigate other allegations of market manipulation by Chinese companies that may violate U.
S.
law, such as controlling the supply of goods to key U.
S.
industries, and its number one targets are pharmaceuticals and pharmaceuticals.
medical device industry
.

Citing a previous White House statement, "these legislation will make our (U.

The bill also calls on the U.
S.
to cooperate with European counterparts to cut off over-reliance on Chinese pharmaceutical products, “The U.
S.
, the European Union and European countries should coordinate a joint strategy to spread their dependence on supply chains from China to multiple countries, especially in medical and pharmaceutical industries.
Members of both parties in
Congress have also warned of excessive reliance on "Made in China", talking about the possible impact on U.

S.

Chinese-made drugs have long been targeted

Chinese-made drugs have long been targeted

Over the past decade, China has rapidly risen to the forefront of global API and generic drug production
.

The number of facilities registered to manufacture APIs in China more than doubled between 2010 and 2019, FDA data shows

In a 2019 Washington Post op-ed by California Democrats Anna Eshoo and Adam Schiff, China's control of drug production has risen to the level of a national security issue
.

It mentions that quality defects continue to occur in the overseas pharmaceutical manufacturing process, and there are problems with the security of the supply chain.

At the end of 2021, Biden said this when talking about some big companies: "They are not competing for consumers, they are consuming competitors; they are not competing for workers, they are trying to gain an advantage in labor.
I want to be clear: capitalism without competition is not capitalism, it is exploitation
.

" He blamed China on the sidelines

It is worth noting that the United States also relies on raw materials and generic drugs produced in India
.

According to the latest USP data, the total number of manufacturing facilities capable of producing more than 10 US-approved API products in India, Europe and China is 183, 83 and 35, respectively

"Competition" relies on attacking opponents, the feasibility is questionable

"Competition" relies on attacking opponents, the feasibility is questionable

In fact, in order to bring pharmaceutical manufacturing back to the United States, Biden and former President Trump have made a lot of efforts before
.

The U.

This effort is a two-pronged approach to the competition bill proposal, which also echoes a 2019 proposal by Anna Eshoo and Adam Schiff to address the pressing issue of U.
S.
pharmaceutical manufacturing being overly reliant on overseas suppliers such as China, and U.
S.
policymakers need to understand potential bottlenecks Where and how to develop capacity outside of China to compensate for any possible supply disruptions; government agencies should work with the private sector to find ways to rebuild U.
S.
domestic generic manufacturing capacity and diversify procurement if necessary
.

However, even if the bill passes, there are questions about its feasibility
.
The FDA has previously explained that there is not enough data to calculate how much of the drug substance in the drug marketed in the U.
S.
comes from China or India
.
In 2019, former acting FDA commissioner (principal deputy commissioner) Janet Woodcock also told a House subcommittee that they did not know whether Chinese facilities were actually producing APIs, how much was being produced, or whether APIs produced in China were globally available.
distribution, including in the United States
.
There is no guarantee that there will be no fatal drug shortages, and no one is willing to take responsibility for acting rashly without data to support it
.