Minn. doctors happy with Obama action on drug shortageby Lorna Benson, Minnesota Public Radio
St. Paul, Minn. — Minnesota cancer doctors say they're pleased that President Obama has taken steps to address acute drug shortages, which have affected several cancer drugs.
The president issued an executive order Monday, directing the Food and Drug Administration to broaden its reporting of potential drug shortages. He also asked the agency to speed up reviews of drug production changes. The FDA must also give more information to the Justice Department about companies that may be engaging in drug price fixing.
Some of these proposals had been previously introduced in a bill co-sponsored by Minnesota U.S. Sen. Amy Klobuchar.
Dr. Edward Greeno, medical director at the Masonic Cancer Clinic at the University of Minnesota, says the president's executive order will shed light on the complex reasons behind persistent drug shortages.
"Anything that lets us have better information and understanding about what's going on is going to give us the opportunity to think more carefully about how to fix it," said Greeno.
But Greeno is also realistic about the challenges. It may not be possible for the FDA to get much advance notice from drug companies when they have a problem with a drug, because most of the shortages appear to be unpredictable, he says.
"A manufacturer may have a problem with a batch of drug and have to recall the entire production lot, and all of a sudden there's no drug in the pipeline for the next two months," said Greeno. "So I don't know how much of the problem will be helped by knowing further in advance."
Greeno does think the president's attempts to rein in price fixing and collusion are critical. Greeno says he and his colleagues are very concerned about the growing "gray market" for drugs -- where medications that are in tight supply are bought up by companies on the secondary market and then resold for a substantial profit.
Jan Merriman, the director of clinical and pharmacy services at Minnesota Oncology, says she has received many calls from these types of second-tier distributors. They offer hard-to-find chemotherapy drugs with a huge markup, but Merriam says she always turns them down.
"Our policy is we do not purchase from those companies because of the pedigree of the drug," said Merriman. "It probably has changed hands a number of times, and we cannot really feel totally comfortable with the pedigree and the source, and making sure that it was kept in proper storage."
Dr. Thomas Flynn, a cancer physician at Minnesota Oncology, says the biggest irony of the shortage is that the drugs in tightest supply are the drugs that should be the most accessible -- generics.
But since they are no longer the big moneymakers, he says there aren't a lot of manufacturers who are interested in making them anymore. And Flynn says that probably won't change anytime soon because manufacturers are restricted by government and private health care plan contracts in what they can charge for the drugs.
"There's probably some limit to what the government and the FDA can actually do to require that these agents be produced. And so the only disappointment perhaps is the fact that we're in a circumstance where the number of manufacturers is limited and therefore any problems that arise are difficult to respond to."
Flynn and other Minnesota doctors say even though there are no easy answers to the nation's drug shortage, they are relieved that the situation is finally getting the attention of lawmakers.