Florida cancer centers will pursue drugs from China as temporary fix to shortage

Florida cancer centers are expected to tap drugs from China as a short-term fix to an ongoing and dire shortage of widely used chemotherapy drugs in the United States.

The Food and Drug Administration is allowing the importation of cisplatin from Qilu Pharmaceutical in China where distribution in the U.S. will be handled by Toronto pharmaceutical company Apotex Corp.

The agency is using regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs, according to FDA Commissioner Robert Califf.

More: National cancer drug shortage hitting Southwest Florida; some patients put on second best drugs

Both cisplatin and carboplatin are commonly used chemotherapy drugs to treat a variety of gynecologic, breast, lung, gastrointestinal and other cancers.

“In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients,” Califf said in a social media post.

It will take two to four weeks before the imported cisplatin is available for patients, said Dr. Lucio N. Gordan, president and managing physician of Florida Cancer Specialists & Research Institute, which has 90 locations throughout the state.

Gordan said what the FDA is doing now in the short term is acceptable but there still needs to be a permanent solution to broader generic drug shortages that have existed for nearly two decades. The FDA maintains a shortage list on its website.

“We have never had a concerted effort to fix the generic drug crisis before but it has not been as severe,” he said. “This is severe.”

The shortage of cisplatin and carboplatin is different because they are used as alternatives for each other depending on patient reactions and other factors, experts say.

Florida Cancer Specialists has 1.2 million established patients statewide and adds 90,000 new patients a year, Gordan said.

There is an allocation system used for determining how much drug supply goes to cancer centers based on patient volumes. Gordan said he expects the distribution from the China importation to be fair.

How long has the shortage been going on?

The shortage began in February for cisplatin and hit in April for carboplatin. It is tied to the cost to produce them is higher than what the manufacturers get paid; another factor is supply chain issues.

In addition the FDA found quality control violations after an inspection at an India-based company, Intas Pharmaceuticals, where production of the chemotherapy drugs was halted, according to a letter from the FDA.

Outcry from cancer centers, hospitals and oncology organizations escalated in recent weeks as health care providers ran out of the drugs, began rationing or had to switch patients to less effective treatment courses.

Florida Cancer Specialists is now out of cisplatin and has a week’s supply left of carboplatin, Gordan said.

Before the Memorial Day holiday the group had gone 12 days without carboplatin before getting a supply, he said.

With 250 physicians in the group, he said “probably hundreds of patients” have been put on alternative treatment regimes because of the chemotherapy crisis.

Moffitt Cancer Center in Tampa is likely to pursue a supply from the China importation, according to Ken Komorny, chief pharmacy officer.

"Moffitt Cancer Center is carefully exploring and likely to purchase drugs imported by China," he said in a statement. "With the FDA allowing the importation of these products that are not approved to distribute in the U.S., this shortage may extend for longer than we expected. Although Moffitt has an adequate supply of drug, based on current demand, the ordering struggle may continue past July. "

Moffitt reports it has treated patients in all 67 Florida counties and impacts about 22% of cancer cases in the state.

Will SWFL hospitals get the imported cancer drugs?

In Southwest Florida, the NCH Healthcare System in Collier County said it expects distribution of the imported cisplatin in the coming weeks, according to Kimberly Thorp, director of pharmacy.

“This will be a positive impact on the overall national shortage issue and help improve cisplatin distribution and allocation to providers,” Thorp said in an email.

Lee Health, a public hospital system in Lee County and one of the largest in the state, is considering using cisplatin from the Chinese firm, Tina Gegeckas, pharmacy director, said.

"We just received the information regarding the product, so we will be evaluating it before deciding whether we will be using it or not," she said in an email.

For now, the system should have enough of the chemotherapy drugs.

What is being done in Washington to address the drug crisis?

The FDA said in a statement that it recognizes “a robust, resilient and safe drug supply chain is essential” for public health and national security.

While it cannot directly affect many of the business decisions related to the drug supply chain, the FDA has encouraged the adoption of advanced manufacturing technologies and mature quality management practices to further these important efforts, among other measures.

“We remain committed to partnering across government, academia, and industry to strengthen and diversify the supply chain, further address drug shortages and ensure Americans continue to have access to drugs that are of high quality, safe and effective,” the FDA said.

Gordan, with Florida Cancer Specialists, said he communicates often with the American Society of Clinical Oncology and other professional organizations on what may be in the works to address the drug shortage long term.

“I am not sure what they are getting told,” Gordan said.

The organization’s website has issued clinical guidance recommendations for physicians on how best to treat patients during the shortage.

In addition, the Association for Clinical Oncology this week said it supports the FDA’s draft guidance to improve oncology clinical trials for accelerated approval.

It is asking the agency to include expected target dates for trials before finalizing the guidance, among other things, according to comments filed May 26.

The Society of Gynecologic Oncology projected in April that the shortage of two chemotherapy drugs “will likely last several months and possibly longer.”

The group issued recommendations effective immediate that include minimizing ordering or not ordering either of the drugs if alternatives are available.

Another recommendation is to increase intervals between treatment cycles when it is clinically acceptable. If the treatment is every three to four weeks, the group advises default to four weeks.

Another temporary approach is going to an alternative treatment regimen.

“These recommendations are not meant to be a substitute for clinical judgment at the individual patient level, nor should they supersede other policies at the institutional level,” according to the organization.

This article originally appeared on Naples Daily News: Toronto firm will import cancer drug from China for U.S. shortage