FDA official gives an unusually clear explanation of cancer drug shortages

There's apparently a cisplatin and carboplatin shortage, and The Cancer Letter has a great interview with Dr. Richard Pazdur, who is the head of their oncology center of excellence: 

“The current cisplatin shortage followed an inspection and subsequent identification of quality issues at a single company’s manufacturing facility,” Pazdur said. “The company shut down the production line, leading to the current shortage. As a result of the cisplatin shortage, a ripple effect was observed leading to an increased demand for carboplatin and the manufacturing challenges in meeting an increased carboplatin demand. 

“To restore supply of cisplatin, FDA has continued to offer assistance to all five manufacturers on anything they can do to increase supply. In addition, we are exploring temporary importation to help meet patients’ needs during the shortage. FDA has also requested that manufacturers submit data to support additional expiration dating for lots already in distribution that are approaching their labeled expiration.”

Pazdur said FDA’s ability to manage shortages is limited.

“Based on current laws, FDA cannot require a manufacturer to report an increase in demand that may lead to a drug shortage,” Pazdur said. “Appropriately, we cannot require a company to manufacture a drug.

“We cannot require a company to make greater quantities of the drug—specifically, to step-up production. We cannot require a distributor to report on the quantities that are distributed and specific purchasers who may be given priority.

“In addition, FDA cannot require that essential drugs, such as cancer therapeutics, have diversified supply chains such that there is not overreliance on a single facility or country for an active pharmaceutical ingredient (API) or key starting materials. However, even when there is more than one manufacturer for a drug, most facilities are operating near capacity and are unable to rapidly fill the void if a manufacturer ceases production due to a manufacturing quality issue,” Pazdur said.

It really feels like there is a problem with generic drugs, the needed volume and their difficulties with manufacturing quality. Clearly, there's not much that the FDA can currently do, but I wonder if there is a place for Congress to provide some kind of incentive to generics manufacturers to keep their quality high for these essential high-volume drugs... 

Doxycycline shortage in South Korea due to 2019 Jiangsu explosion?

Via a Google Alert, this interesting explanation of a recent medicine shortage in a Korean medicine outlet: 

Korean doctors are finding it difficult to treat patients due to the shortage of doxycycline, an antibiotic, industry sources said. A local drugmaker stopped manufacturing doxycycline-containing medicines in November because it could not import raw materials, they said...

...The shortage of the doxycycline supply is likely to continue. Industry officials said a chemical plant explosion in Chenjiagang Chemical Industry Park in Xiangshui County of Yancheng in Jiangsu Province led to a burndown of a raw material drug factory in 2019. Since then, the Chinese government has been delaying GMP approval for a renewed plant, they said.

Youngpoong Pharmaceutical said it discontinued the manufacturing of Youngpoong Doxycycline Tab. in November last year. It may resume production in May at the earliest, the company said.

“Raw materials come from China, but the Chemical Industry Park in Yancheng in Jiangsu Province had an explosion, which burned down the raw material factory,” an official at Youngpoong Pharmaceutical said. “To make matters worse, the Chinese government put brakes on the resumption of the plant citing environmental issues, which led to approval delay.”

The official had expected that the factory would win the license in March, but the approval was put off longer than anticipated, he added.

It's surprising to me that the Chinese haven't gotten this plant (or this supply chain) back up and running. (This explosion was rather prominent, and has sent all sorts of odd shockwaves through the chemical industry and into the broader economy.) 

Why there are shortages of generic sterile injectables

This Fortune article by Erica Fry about Pfizer/Hospira's generic sterile injectable shortage/manufacturing problems is very informative, and I feel that it's the first piece to get the economics of the field (which seem wildly apparent to me) exactly right: 

The medications most vulnerable to running short have a few things in common: They are generic, high-volume, and low-margin for their makers—not the cutting-edge specialty drugs that pad pharmaceutical companies’ bottom lines. Companies have little incentive to make the workhorse drugs we use most. 

Congress’s response was to pass legislation in 2012, requiring manufacturers to give more notice ahead of anticipated shortages—but that seems to miss the point: What we’ve been witnessing, in slow motion, is market failure. It boils down to a lack of economic incentives. 

Manufacturers of widely used, inexpensive drugs make relatively little off the products, whose prices are largely determined in contract negotiations between drugmakers and group purchasing organizations (or GPOs), which exist to broker better deals for hospitals. That makes this a high-volume, low-cost game, a reality that has driven consolidation in the market. It’s also a highly regulated and somewhat costly industry, which has chased some companies out. The economics make it hard to invest in the business or in building supply chain redundancy. When shortages happen, the financial losses tend to be marginal and temporary; there are too few players for customers to take their business elsewhere. What’s left is a system with just enough inventory to get by if nothing goes wrong. 

Last year, a lot went wrong.

It seems to me that a field that relies on low margins and high volumes and high regulatory standards and high capital requirements will have a low number of players, and a very low number of entrants.