But private sector initiatives can only go so far. More governmental action is needed to require advance notice and public reporting of drug shortages to the FDA, the reasons for the limited supply and the expected timetable for resumed production. FDA, in turn, should make this information available on its website and work with manufacturers to speed product reviews and safety inspections, easing some of the regulatory burden in an emergency. With just two to three months of products in the supply chain, speedy action and additional warning time could mitigate some of the risk and help avert shortages.
Such an approach is supported by Sen. Amy Klobuchar (D-MN), who has introduced legislation in this Congress that would require such notifications, and give the FDA latitude to expedite approval for alternative treatments.
Drug shortages are a major safety issue, and one that deserves prompt attention from both the pharmaceutical industry and the government agencies that oversee them. With patient lives on the line, we can't afford a shortage of concern.
Mike Alkire is president of Premier Purchasing Partners, part of the Premier healthcare alliance. He may be reached at Mike_Alkire@PremierInc.com