“It used to just be [an] anecdotal [problem],” Klobuchar said. “Now the numbers are showing this to be way more than anecdotal.”
‘It will bring down the crisis we’re seeing’
The drug shortage problem has progressively gotten worse over the past seven years at least. By the White House’s count, there were 61 products on the drug shortage list in 2005. Today, there are 231, Klobuchar said. More than half of those are caused by problems at factories or manufacturing and shipping delays, but a lack of raw materials and financial incentives (like a company merger, or a drug that doesn’t make enough money) can cause problems as well.
“We’re very confident that, while this will by no means solve the whole problem, it will bring down the crisis that we’re seeing,” she said.
Klobuchar’s bill, should it pass (and it has bipartisan support), would be an extension of an Obama executive order issued in October meant to force early notification among drug manufacturers. Before the executive order, manufacturers only had to disclose the discontinuation of a drug produced by a single manufacturer. Obama endorsed Klobuchar’s legislation when issuing the order.
The FDA says more than 100 potential drug shortages have been averted since October alone. In February, the FDA highlighted two such successes — cancer drugs Doxil and methotrexate. Their manufacturers gave early notice that the drug supply was running low, and the FDA ordered alternatives, including a replacement drug from the United Arab Emirates.
For its part, the pharmaceutical industry says it’s willing to work with the government to put more stringent shortage safeguards in place. The Pharmaceutical Research and Manufacturers of America, the major lobbying shop for pharmaceutical companies, said it has “long been in favor of working with all stakeholders on targeted solutions to help prevent and mitigate drug shortages.”
“It is critical that we seek a more comprehensive understanding of the many circumstances that can lead to a drug shortage as industry, Congress, FDA, patients, providers and other stakeholders try to identify meaningful ways to help alleviate, mitigate and address this critical problem,” PhRMA President John J. Castellani said in a statement. “PhRMA and its members have worked — and will continue to work — diligently to this common goal.”