Although the causes of drug shortages--manufacturing problems, lack of API, a stricter FDA shutting down plants, industry consolidation and the thin margins of generics--are well known, regulators and legislators remain stymied on how to solve the problem. There are "multiple factors and it's very difficult to identify which one is most important," Peter Lurie, a senior FDA adviser, tells Reuters.
Despite the standard list of causes, no one is able to explain fully why the shortages are escalating. The FDA expects reports of drug shortages to rise over the next few months to years, agency spokesperson Lisa Kubaska says in an email. Unfortunately, FDA and congressional proposals offer little hope of solving the long-term problem, Reuters reports.
A widely acknowledged first step is better communication among manufacturers and the FDA, which has helped avert 99 shortages this year as a result of advance notice from the drugmakers. Manufacturers aren't required to report shortages to the FDA, but when they do, the regulator asks about the cause, how long the shortage is expected to last and how it can help. "Sometimes there is a quality issue or other manufacturing issue that FDA is able to work with the firm on, and sometimes the company needs FDA assistance with expediting review to help prevent or address a shortage," Kubaska says in the email.
In Canada, where there's reluctance among some manufacturers to report shortages, officials are trying the "big stick" approach. Health Minister Leona Aglukkaq has told drugmakers and medical associations that unless they figure out a way to alert doctors about the growing number of shortages, she would impose a solution, reports Edmonton CTV. The companies have since agreed to pool information on shortages and post details on two public websites.
U.S. Sen. Amy Klobuchar introduced a bill in February that would force drug companies to inform the FDA about looming shortages, but the bill does little to prevent shortages in the long-term. "People aren't in agreement on how to solve it in the long-term, and not a lot of bills are going through Congress," Klobuchar told Reuters.
The FDA's drug shortage program, run by Associate Director Valerie Jensen, consists of 5 scientific and regulatory experts, up from three a few years ago. They coordinate with other CDER personnel to conduct medical necessity assessments of the drugs, consider action on inspection reports, and assess the proposals of drugmakers as they attempt to avoid supply disruption or increase production.
- here's the Reuters story
- see the article on Canada's tactic