U.S. regulators and the country’s top cancer doctors urged Congress to help end the shortages of more than a hundred drugs, including those for deadly tumors.
The House and Senate are working to merge bills passed last week that would require drugmakers to notify the Food and Drug Administration when they expect a disruption to production of medicines. The number of shortages have tripled since 2006 and include cisplatin for ovarian cancer and paclitaxel, a therapy given to women with breast cancer.
The FDA has prevented more than 150 shortages since October when President Barack Obama directed the agency to gather information earlier about potential shortfalls to help find alternate sources of the treatments, Sandra Kweder, an agency deputy director, said today at the American Society of Clinical Oncology meeting in Chicago. Still, about 90 shortages have occurred in 2012 and generic drugmakers are still struggling with limited manufacturing and quality issues, the FDA said.
“Patient care has actually been threatened in many cases as a result of these drug shortages,” said Richard Schilsky, a specialist in gastrointestinal cancer at the University of Chicago. “There is still unpredictable availability of many drugs. We are never exactly sure when a generic drug is going to go out of supply.”
One of the generic medicines ran out for John Mahan, a fire fighter in Nashville, Tennessee. In February of 2011 he was diagnosed with abdominal cancer and put on a three-drug regimen. He developed an allergic reaction to his initial treatment and was moved to another combination of medicines with an old chemotherapy drug 5-FU with another longtime therapy, leucovorin.
After his first treatment with the new therapy, his oncologist told him they’d run out of leucovorin.
“My initial reaction was, you have got to be kidding, right?” said Mahan, who traveled to Chicago for the cancer doctors’ meeting to talk about the shortages. “Until this impacts you personally, most people aren’t even aware there is a shortage going on.”
For several months until he switched to a new therapy, his doctors had to find a pharmacy that could formulate an oral version of leucovorin. The oral version, though, had more side effects, giving him an upset stomach, loss of appetite and fatigue, Mahan said in an interview.
“You go through all this treatment to have hope,” he said. “It takes away hope when you can’t get your drugs.”
There are 12 cancer drugs where there isn’t enough supply to meet demand, according to the FDA.
Driving the surge in shortages are changes in the generic-drug manufacturing industry, Kweder said. Consolidation means there are now just a handful of companies that supply most of the world’s generic medicines. When there is a quality problem at one plant and manufacturing need to be shut down, it can cause a shortage of dozens of treatments.
“If one company makes 30 products and they have a problem, suddenly 30 products are at risk of a shortage,” Kweder said. “Early notification by a manufacturer of when they are having production difficulty makes a huge difference in our ability to prevent the public from bearing the burden of drug shortages.”
The FDA has had to close production because of safety issues, such as shards of glass and metal particles found in vials, Kweder said. Some generic drugmakers haven’t kept pace with the boom in use and need better manufacturing facilities to avoid production disruptions, she said.
The separate versions of the legislation passed by the House and Senate last month would require companies to report potential drug shortages to give regulators time to find alternate sources. The requirement is part of a $6.4 billion bill that would fund FDA reviews of new medicines and devices through 2017 by charging user fees to companies. A unified version of the legislation is expected to be sent to the president before Congress takes its August recess.
The law doesn’t impose fines or other penalties on companies that don’t notify the FDA, something the cancer doctors’ group has been pushing for.
“If there is no teeth in that legislation some companies may not report as required,” said Schilsky, who is chairman of ASCO’s government relations committee.
The legislation also won’t do anything to address the current shortages or offer incentives for generic drugmakers to continue producing older, less-profitable medicines.
To address the shortages, the FDA said it has been going to drugmakers to request production of medicines in short supply. New York-based Pfizer Inc., the world’s largest pharmaceutical maker, agreed to re-introduce several treatments, such as paclitaxel and irinotecan, to help address the lack of supply.
The FDA allowed for temporary importation of unapproved foreign drugs from India in February to give ovarian cancer and multiple myeloma patients access to the Johnson & Johnson medicine Doxil, which was in short supply after the New Brunswick, New Jersey-based company’s contract manufacturer said it planned to get out of the business. The FDA only relies on foreign sources when it can’t resolve a shortage with already approved treatments.