May 22, 2013
Obama addresses drug shortages
by BY LAURAN NEERGAARD Associated Press
Nov 02, 2011 | 222 views | 0 0 comments | 3 3 recommendations | email to a friend | print
WASHINGTON  — Unprecedented drug shortages are threatening the lives of cancer patients and other seriously ill people, and the Obama administration’s plan to tackle them is but a small step toward solving a complex problem.

President Barack Obama ordered the Food and Drug Administration on Monday to take new steps to send out early warnings about looming shortages and try to avert them.

“Even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health care facilities all over the country,” Obama said.

There’s already a crisis in the eyes of many frustrated doctors and hospitals who are scrambling for supplies of medicines ranging from common chemotherapies, to anesthetics used in surgery, to the electrolytes that are crucial to IV feeding in intensive care. Fifteen deaths have been blamed on shortages. Patients have had treatments delayed, surgeries canceled, or had to use second-choice medications. Hospitals are reporting price-gouging — such as a drug that usually costs $26 being offered for $1,200.

Sometimes, “you have to look the patient in the eye and say, ‘I can’t treat you. I certainly can’t treat you the way I meant to treat you,’” said Dr. James Speyer, medical director of the clinical cancer center at New York University Langone Medical Center.

“That’s a terrible thing to have to do, and it’s happening across the country,” added Speyer, who said Obama’s action is important but doesn’t address one key part of the problem — drug profits. “Unfortunately, we’re going to be living with the problems of these shortages for some time.”

It’s unthinkable to patients who find themselves caught in the mess.

“How in the United States of America could critical lifesaving or life-prolonging drugs be in short supply?” asked Jay Cuetara, 49, of San Francisco, who said chemotherapy to hold back his advanced cancer recently was delayed by a week when his hospital ran out and couldn’t get more. He joined Obama in the Oval Office Monday as the president signed an executive order directing the FDA’s next steps.

Just how big the shortage is depends on how you count, but this is a record-setting year. The FDA reported 178 drug shortages last year and says it sees more this year. The University of Utah’s Drug Information Service reports higher numbers: 232 shortages this year, up from 211 last year.

Recent shortages could have been even worse: The FDA said Monday it had prevented 137 more drug shortages in the past two years, when companies told regulators they were having trouble. Options include getting other manufacturers to ramp up their own production, helping to find alternative suppliers of key ingredients, sometimes even allowing temporary importation of competing drugs sold only abroad.

Obama’s executive order instructs the FDA to take more such steps — to push more companies to come forward about potential shortages, to speed applications to change production of those drugs, and to alert the Justice Department about possible collusion or price-gouging

The administration also supports legislation pending in Congress that would go a step further and require more industry reporting of shortages,

Overwhelmingly, the drugs in short supply are injectable medications used mostly by medical centers. They’re usually generic drugs, not pricier brand-name versions.