By David Pittman, Washington Correspondent, MedPage Today
WASHINGTON — The total number of active drug shortages has remained constant nearly a year after Congress passed legislation trying to make it easier for the FDA to prevent such shortages, data show.
The University of Utah Drug Information Service counted 300 “active” — or ongoing — drug shortages at the end of April, just about the same as it did at the end of December 2012 (299 shortages) and September 2012 (282 shortages).
However, the number of new shortages is well off its pace from years past, with 54 so far this year, Erin Fox, PharmD, director of the school’s Drug Information Service in Salt Lake City, said. There were 204 new shortages last year and 267 in 2011.
“For what Congress can legislate, yes, it did help,” Fox told MedPage Today. “At least the FDA is doing more to prevent these shortages from happening in the first place. That’s the silver lining in all of this.”
Lawmakers in Washington included provisions in a large bill last summer aimed at helping the FDA work with drug manufacturers in advance to prevent shortages from occurring.
The FDA Safety and Innovation Act requires manufacturers to notify the FDA as soon as possible when a production interruption occurs in a “life-supporting” or “life-sustaining” drug and at least 6 months in advance if such a product is being discontinued.
“All of us involved with it knew it wouldn’t solve everything, but it helped,” Fox said, pointing to the fewer new shortages as evidence.
The FDA said the number of notifications per month has more than doubled since the bill was signed into law early last July. Before the law, manufacturers’ advanced notice was purely voluntary.
“We have made further progress in being able to prevent many shortages from occurring so far in 2013 due to the ongoing notifications from manufacturers,” FDA spokesman Stephen King told MedPage Today.
But the problem isn’t going away. Pediatricians have recently noted shortages of a number of critical electrolytes and other nutrients including sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements, and others.
Several senators, led by Sen. Al Franken (D-Minn.), wrote the FDA last week urging action to mitigate the drugs. “It is essential that we do all we can to prevent shortages in products that compose total parenteral nutrition so that children’s hospitals can again focus on providing the best care to their patients,” the senators wrote.
Fox noted just two manufacturers produce such products and one — American Regent in Shirley, N.Y. — ran into manufacturing issues and had to shut production down totally.
The electrolyte shortage came up during last week’s Pediatric Academic Societies’ annual meeting, where congressional staffers defended their work, saying such shortages are very difficult to address. Congress can’t force manufacturers to produce such products, they said.
“If there was a magic wand, we would have waved it,” Rodney Whitlock, director of health policy for Sen. Chuck Grassley (R-Iowa), said. “Your government controls a lot of things. This one, we don’t have it.”
The FDA and others continue to point the finger at manufacturers’ lack of quality as shortages’ main cause. Production issues have caused some of the already small handful of sterile injectable manufacturers to shut down production, creating the shortages.
“In all cases, we continue to work with the companies on these quality issues while also doing everything possible to keep the critical drugs they make available,” King said.
Last summer’s legislation only addresses the symptoms and doesn’t tackle the problem, said Joel Zivot, MD, chair of the grassroots organization Physicians Against Drug Shortages. He pins the blame on group purchasing organizations, which, he says, squeeze the profit margins of such drug products by acting as middlemen between manufacturers and pharmacies.
“Until they address the market failures, it won’t change,” Zivot said.
The Government Accountability Office is currently studying the issue and is due to release its findings early next year, he said.