Set below is another opinion piece published in The Wall Street...

Set below is another opinion piece published in The Wall Street Journal overnight.

The drums are really starting to beat for US in country manufacturing of drugs rather than rely on China and India. Again playing to the new manufacturing strength of MYX on US home soil.

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Relying on Foreign Drugs Is Dangerous

Generics are often made in India, with ingredients from China. Time to diversify the supply chain..


By
Scott W. Atlas and
H.R. McMaster
April 28, 2020 1:07 pm ET


Pills move through a sorting machine at a pharmaceutical plant in Andhra Pradesh, India.

PHOTO: SARA HYLTON/BLOOMBERG
Health security is critical to national security. The Covid-19 pandemic is a moment to re-evaluate U.S. dependence on China for pharmaceutical ingredients and to solidify the pharmaceutical supply chain in advance of proliferating threats.
Americans filled the equivalent of 5.8 billion 30-day prescriptions in 2018. That doesn’t count the hundreds of millions of vaccinations administered annually. In 2019 the Food and Drug Administration estimated that 40% of finished medications and 80% of active pharmaceutical ingredients were manufactured overseas, mainly in China and India.
While U.S. pharmaceutical companies may preserve redundancy in their sources for patented drugs, the generic drug business, which accounts for more than 90% of all U.S. prescriptions, prioritizes low cost over supply-chain resiliency. Most generics, including antibiotics, are imported from India—and India imports some 70% of its active ingredients from China. America needs to understand and diversify sources of supply, as well as maintain a strategic reserve of antibiotics and the key drugs for the most prevalent serious diseases.
Beyond scale and complexity, details on drug manufacturing are opaque and complex. The Food and Drug Administration requires country-of-origin markings, but the U.S. Court of Appeals for the Federal Circuit ruled in February that processing ingredients into tablets in the U.S. is enough to constitute “manufacturing.” A drug made into tablets in the U.S. with active ingredients from India may list only the U.S. as “principal place of business” for FDA purposes. Labeling should be straightforward, but not at the sacrifice of security.

Protecting the drug supply also requires guarding against poor-quality and counterfeit medications, a repeated problem of medications from China in particular. Although the FDA conducts 3,500 inspections of generic plants a year, additional measures are necessary. More than half of FDA inspections are conducted on foreign manufacturers, but only a small minority are done unannounced in China and India. The U.S. government should require far greater on-site access and increase the funding and staff to implement that policy. It is also time to stop viewing the reimportation of drugs as a potential solution without serious downsides.
A strategy to diminish supply-chain risk must also take account of China’s dependence on U.S. drugs. The U.S. is the world’s predominant source of pharmaceutical innovation, including new cancer drugs, next-generation biopharmaceuticals and tests that determine which patients will benefit from those drugs. China is highly reliant on foreign sources of more-expensive brand-name drugs, which make up 90% of overall drug revenues, exporting only 1.2% of all medications in total value; the U.S. is among the top five exporters.
China is deeply dependent on U.S. cancer drugs in particular. Of those launched world-wide from 2013 to 2017, 51 of 54 were available within two years in the U.S. Only two were available in China. Cancer survival in China is only half that in the U.S. The Communist Party recognizes this problem. Its Healthy China 2030 Plan exempts most drugs from taxes and omits U.S. cancer drugs from tariffs placed on other medications in 2019.
China has emphasized generating new pharma patents. China now exceeds the U.S. in published applications, even though the U.S. still leads by a wide margin in patents that are ultimately granted. Mutual dependence on uninterrupted access to critical drugs, among both allies and adversaries, is a vital part of risk mitigation. Leaders should make clear that the U.S. will never withhold pharmaceuticals from other nations for coercive or punitive purposes, except when faced with hostile actions, such as acts of war.
Perhaps most important, policies must encourage pharma innovation and production. Reducing vulnerability to health threats such as Covid-19 rests on American discovery and competitiveness. While the U.S. leads the world in health-care innovation, this is no reason to be complacent. Congress should strengthen tax incentives for high-risk investments in early stage medtech and life-science companies, including drug development, and target additional incentives to domestic drug manufacturing.
Developing a new drug typically costs more than $2.5 billion and takes more than a decade. Safety standards shouldn’t be compromised, but lengthy clinical trials can be streamlined. The FDA should continue the impressive work it began in 2016 to expedite drug approvals. During 2017 and 2018, yearly new drug approvals increased by around 70% relative to the eight years under the Obama administration. Finally, legislators must avoid the temptation to impose price regulation and limit patent protections. These measures delay drug launches, reduce access and crush research and development.
A secure drug supply chain couldn’t have made up for the Chinese Communist Party’s decision to conceal the threat of Covid-19. But it is essential for mobilizing resources to mitigate the crisis. And the stakes are high, even in normal times. More than 15 million American seniors, or 1 in 3, take five or more medications daily. As the U.S. population ages, society will become even more dependent on drugs indispensable to treating the biggest killers—heart disease, cancer and stroke. Preventing an interruption of the supply of vital medications that save lives and treat diseases, whether during pandemics or in routine care, is a matter of national security.
Dr. Atlas is a physician. Lt. Gen. McMaster, a retired Army officer, served as White House national security adviser, 2017-18. Both are senior fellows at Stanford University’s Hoover Institution.