The generic drug industry's major trade group will develop a private-sector system that would warn about medicine shortages, even as the government threatens to step in and officially mandate similar action.
Generic drugmakers would create an advance warning system of sorts by working with distributors, wholesalers and other parts of the system that brings drugs to the marketplace, Ralph Neas, head of the Generic Pharmaceutical Association, told Reuters after a Senate hearing on drug shortages. He has suggested such a process should not solely involve the FDA, though said industry and regulators can, and should work together to make such a process succeed.
"They just don't have the analytical background with respect to the private sector," Neas told Reuters.
Maybe so, but government efforts to address the problem are increasing. At least one Senate bill is pending that would compel companies to inform the FDA when shortages are likely, Reuters notes. In October, President Obama also issued an executive order calling on the agency to get better advance notice when there are supply issues. And on Dec. 15, in response to another executive order, the FDA issued an interim final rule requiring manufacturers to report any interruptions in production for critical drugs. But the Government Accountability Office recently concluded that the FDA didn't have enough systematic data, resources or performance measures to respond to drug shortages on its own under existing regulations.
A solution to the drug shortage problem is crucial. FDA says early notification helped it prevent 137 shortages over the previous two years by working with other companies, Reuters reports. But drug shortages this year have now reached 220, up from 56 5 years ago.
- here's the Reuters story
- check out the FDA's interim rule announcement
Special Report: Top drug shortages by treatment category
GAO: FDA needs more power to address drug shortages
Drugmakers respond to shortages order, HHS report
Obama takes aim at drug shortages