President Barack Obama Monday issued an executive order directing the Food and Drug Administration to focus on reducing prescription drug shortages. Those shortages, which have tripled since 2005, have been blamed in patient deaths. They have hit injectable cancer drugs, anesthetics and electrolytes the hardest.
The president’s order calls for doubling the staff in the FDA’s drug shortages program and calling on the Justice Department to investigate whether “gray market” wholesalers are hiking prices of drugs in short supply. The administration also sent letters to drug companies asking them to voluntarily disclose production problems that may lead to shortages in the future.
In a conference call with reporters, Health and Human Services Secretary Kathleen Sebelius explained the order also gives official support for a pending bill that would make that reporting mandatory.
“Calling on Congress to step up and pass the bills that they have, in a bipartisan fashion, already addressed would be very helpful in this puzzle,” Sebelius said.
That bill was introduced by Sen. Bob Casey of Pennsylvania in February.
The FDA, which reported 178 drugs on the shortage list last year, predicted that only will increase this year. The shortages have led hospital pharmacies to ration drugs and scramble to find less desirable replacements.
Quakertown resident Sarah Batalka is heartened by the announcement. She has a rare form of muscular dystrophy that leaves her unable to retain the electrolytes her body needs to survive. She requires an IV drip of magnesium sulfate for up to 10 hours a day.
Twice within the past seven months she was told by her home pharmacy company they had as little as a few weeks’ supply left, which sent her scrambling to find more.
“It’s like hearing there’s only three weeks of oxygen left. Because you can’t breathe without it. When it’s gone, it’s gone,” Batalka said. “It’s very scary.”
Though Obama’s order is limited in scope, Batalka said she hopes the added attention to the problem will speed up work on finding a solution by lawmakers and the pharmaceutical industry.
“I really feel a lot of hope that I sort of hadn’t been feeling lately,” Batalka said.