CoronaV Impact on API Supply & Vaccine Efforts

PHARMALOT
‘The time to worry is now’: The coronavirus in China could threaten pharma’s ingredient sourcing
By ED SILVERMAN @pharmalotjanuary 27, 2020
Chinese pharma
Chinese workers monitor pill production at a factory in Beijing.
TEH ENG KOON/AFP/GETTY IMAGES
As a novel coronavirus spreads through China and rattles the rest of the world, the pharmaceutical industry is on guard over the adequacy of its global supply chain.

Over the past decade, China has become a bigger player in the market for active pharmaceutical ingredients, which are the building blocks found in each drug. China is now home to 13% of all facilities that make ingredients for medicines that are sold in the U.S., according to the Food and Drug Administration. By comparison, 28% of such facilities are in the U.S. and 26% are in the European Union.

Most ingredient production is concentrated in Zhejiang province, which is something of a manufacturing hub that lies along the East China Sea, far from the city of Wuhan, where the outbreak began, explained a source familiar with the Chinese pharmaceutical market but who asked not to be named.

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But as the virus proliferates, illnesses and deaths mount, and the Chinese government increasingly locks down portions of the country, there are likely to be new questions about adequate production and supplies of active ingredients going forward, as well as the extent to which shipments can be made if transit hubs are out of commission.

“The time to worry is now,” said Steven Lynn, a former director of the FDA Office of Pharmaceutical Quality, who subsequently worked in global quality compliance for both Novartis and Mylan before leaving to start his own consulting firm.

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“I would be asking my supply chain folks what do we have coming from China, what’s our inventory, and if we don’t have enough, can we get as much as fast possible? And remember, this isn’t just a U.S. problem. It’s a global problem if China starts shutting down its borders.”

Of course, the situation can vary.

Generally, most drug makers have more than one ingredients supplier available for each medicine. A GlaxoSmithKline (GSK) spokeswoman, for instance, wrote us that the company maps out reliable supplies by stockpiling inventory and “dual sourcing” ingredients, as well as conducting risk assessments.

For large, brand-name companies, this can help explain why adequate supplies may be less of a concern, according to Martin VanTrieste, a former chief quality officer at Amgen, who now heads Civica Rx, a nonprofit that is working with hospitals and health plans to supply lower-cost generics in the U.S. market.

Although data are hard to come by, he estimated brand-name drug makers obtain only a small fraction of their active ingredients from China, given apprehension over quality issues. “If the virus stays contained, the problem won’t be that big on the branded industry,” he said. “But if it isn’t contained, it could be a serious problem.”

Roughly 80% of active ingredients used by commercial sources to produce finished medicines come from China.

CHRISTOPHER PRIEST, DEPUTY ASSISTANT DIRECTOR, U.S. DEFENSE HEALTH AGENCY

For the moment, an FDA spokesman wrote us, the agency has not received any shortage notifications from manufacturers that make products for the U.S. market due to the current coronavirus outbreak.

On a wider scale, though, there may already be reason for concern.

Roughly 80% of active ingredients used by commercial sources to produce finished medicines come from China, Christopher Priest, deputy assistant director at the U.S. Defense Health Agency, said in testimony given last July to the U.S.-China Economic and Security Review Commission.

This view reflects the fact that the overall market for prescription drugs consists of brand-name and generic medicines. Again, data is lacking on the volume of ingredients from China that reach the U.S. But a growing number of Indian generic makers purchase ingredients from China. In fact, the Indian government is trying to find ways for its domestic industry to become less reliant on Chinese suppliers.

There are implications here for consumers elsewhere — and the possibilities can be seen by playing connect the dots. In the U.S., for instance, medicines imported from India account for 40% of all generics used. And roughly 90% of all prescriptions written in the U.S. are for generics. The upshot: An untold amount of ingredients made in China are finding their way to U.S. medicine cabinets.

A spokeswoman for the Association for Accessible Medicines, which represents generic drug makers in the U.S., wrote us that “most of our members have a second source for all active pharmaceutical ingredients. In addition, they don’t order per batch. Rather, each order is for two to five years of manufacturing needs.”

But the reliance on ingredients from China is already worrisome, said Rosemary Gibson, a health care and patient safety expert at The Hastings Center, a bioethics nonprofit, and co-author of “China Rx: Exposing the Risks of America’s Dependence on China for Medicine,” a book that examines the growing clout that China has a global ingredients supplier.

She pointed out that 85% of medicines in the U.S. strategic national stockpile depend on some component coming from China, whether it is an active ingredient, the chemical intermediates used to make ingredients, or raw materials. And the novel coronavirus may exacerbate the issue if China keeps supplies for itself or stops export of certain medicines to stockpile on a large scale for their own health care system.

“When you think about it, though, all it takes is for one ingredient plant to cause a problem in the near term. The production of some medicines depends on one (ingredient) supplier,” she explained. “This is why long supply chains for critical products should be rethought.

“We need a government entity that monitors global supply and demand — and events like this outbreak — to understand our vulnerabilities, predict possibilities and have a plan to prepare, rather than scramble. We track food supplies around the world. We do this for energy supplies. We need to do the same thing for medicines.”

About the Author
Ed Silverman
Ed Silverman
Pharmalot Columnist, Senior Writer