China envisions becoming an industry innovator producing drugs and medical devices, but the country “lags far behind” the U.S. when it comes to the pharmaceutical industry, according to a report released by Sen. Marco Rubio Tuesday.
In “Made in China 2025 and the Future of American Industry,” the Florida Republican looks at China’s long-term plans to become a pharmaceutical powerhouse. In many ways, China has already made huge strides in the industry by controlling a huge portion of the active pharmaceutical ingredients (API) market, Rubio’s report pointed out.
“Chinese policymakers aim to make China’s domestic biotechnology industry the medicine cabinet of the world. To a large extent, they have already succeeded in achieving dominance in the lower end of the pharmaceutical and medical technology value chain,” the report stated.
For now, the main concern is the safety of those drugs should they be sold to American consumers. Many Americans take drugs without realizing their components originated in China, but scares, like the valsartan recall in July, make consumers wary. Chinese manufacturer Zhejiang Huahai Pharmaceuticals had to recall active substances found to have carcinogens in more than 22 countries.
The Chinese Drug Administration (CDA) is trying to improve its reputation in many ways, including by “bringing China into better alignment with international drug assessment standards,” according to Rubio’s report.
The U.S. Food and Drug Administration (FDA) does approve all drugs and ingredients before they can go on the market in the U.S., but Rubio’s report highlighted that “American quality control over foreign producers” is not always up to par.
“A report by the U.S. Government Accountability Office (GAO) estimates that of 535 of China’s facilities subject to FDA monitoring, as many as 243 – almost half – may have never been inspected between 2010 and 2016,” the report stated.
Meanwhile, some U.S. companies are teaming up with Chinese companies that want to develop products that ultimately gain FDA approval, reported Axios.
“The U.S.-China pharmaceutical and medical technology trade relationship represents short-term opportunities for American businesses and long-term vulnerabilities for the American public,” Rubio’s report warned.
Rubio’s report comes at an interesting time when many lawmakers are touting out-of-the-box solutions for high prescription drug prices. Senate Finance Committee Chair Chuck Grassley has held multiple hearings on drug prices since the 116th Congress convened and is once again pushing legislation to let consumers import cheaper drugs from Canada, according to his office.
Another out-of-the-box proposal? The Trump administration is pursuing an “international pricing index” that would reduce certain Medicare drugs to what other countries pay after announcing the policy Oct. 25.
It is surprisingly parallel to a proposal from Independent Vermont Sen. Bernie Sanders. Sanders and Democratic California Rep. Ro Khanna announced they would introduce the Prescription Drug Price Relief Act in the 116th Congress on Nov. 20. The bill would “require the Secretary of Health and Human Services to make sure that Americans don’t pay more for prescription drugs than the median price in five major countries: Canada, the United Kingdom, France, Germany and Japan,” according to a press release.
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