If you bring together 5 pharma-connected people representing industry, regulation, research and patient advocacy to discuss how to solve drug shortages, what will you get? A great deal of consensus, it turns out.
A panel at the BIO 2012 convention Monday agreed that the problem of shortages is complex, involving the thin margins on generic injectables and a need for high-quality manufacturing standards and better communication of plant problems--as well as a need for more flexibility from the FDA.
The panel's acknowledgement that the problem is complex and its root causes not yet fully known ran counter to a U.S. House of Representatives report Friday that lays the blame directly on the FDA and suggests that overzealous regulatory action that has shut off manufacturing capacity is the main cause of drug shortages. But one suggestion that stood out at the BIO discussion was that the FDA look for ways to maintain supplies, even as it works with manufacturers to fix quality problems.
"Safety is not negotiable, but what about regulatory discretion," said Peter Pitts, a founder of the industry-funded Center for Medicine in the Public Interest. He suggested that if there are three producers of a drug each with a different problem, perhaps the FDA could decide which plant poses the least risk and even allow a drugmaker to "jury-rig" a line and keep supplies of a vital drug flowing while issues at the other two facilities are addressed.
Gerry Migliaccio, senior vice president of network performance at Pfizer ($PFE) Global Supply, said his experience with other regulators around the world is that if you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.
The FDA might allow some temporary fixes that fall in line with that thinking, explained Jouhayna Saliba, senior regulatory program manager at the FDA's Drug Shortage Program. If a company discovers impurities that could be filtered out, the agency might allow the product to be shipped along with filters and explanations of how they are to be used in order to avoid a shortage, she said.
But everyone agreed that notifications can go only so far and that the industry needs to study the root causes of the issues to create a plan for long-term, sustainable supplies of essential drugs. As Saliba said, "This is not a problem that is going to go away soon."
House report blames FDA actions for drug shortages
Drug shortages dominate 2011 headlines
Ben Venue's idled plant triggers 'dire' leukemia-drug shortage
Drug shortages have fallen dramatically, FDA says