Monday, December 19, 2011

Drug shortages hit an all-time high – - Blogs

Between 2006 and 2010, drug shortages increased by more than 200%, according to a Government Accountability Office report released Thursday. There were a record 196 shortages last year, and even more are expected in 2012.

“These shortages often force Americans to go without treatment,” Senator Tom Harkin said.

Renee Mosier is one of those patients who has been forced to forgo treatment and look for alternatives. The 61-year-old was first diagnosed in 2006 with ovarian cancer. After several successful surgeries and chemotherapy treatments, the cancer came back this past June.

Her doctor suggested a chemo regimen that included Doxil, one of the most successful drugs to help keep ovarian cancer at bay. The only problem? Doxil wasn’t available. It is one of the drugs on the drug shortage list, and has not been available for several months. On average, the GAO report found that most shortages last more than 9 months.

For Mosier, it’s not just about waiting for the drug. “It’s a life and death thing,” she says.

More than half of the drugs of the shortage list are considered critical, meaning there are no other alternatives for them. Doxil has no generic equivalent. The drugs most often in short-supply included anesthetics and oncological drugs.

The report pointed to manufacturing issues, such as shutdowns, and technical difficulties as being some of the biggest reasons for the drug shortages.

In addition, many drugs, like Doxil, are very difficult to technically replicate. So, once there is a shortage, it is almost impossible for another manufacturer to start producing a similar drug to relieve the shortage.

The report suggested that the Food and Drug Administration could better respond to the shortages if manufacturers were required to report to the FDA of potential shortages, allowing the FDA to find alternatives to deal with the potential shortage. Currently there is no such legislation requiring drug manufacturers to do so, and the FDA most frequently finds out about shortages from doctors and patients.

In addition, the FDA does not maintain its own drug shortage data, which would better enable the FDA to monitor trends.

A result of the drug shortage has been price gouging and the creation of a “grey market” for hard-to-find drugs. “Aggressive measures are necessary to crack down on anti-consumer practices promoted by so-called 'gray markets' that inflate prices, creating a public health menace," Senator Richard Blumenthal said. "There should be zero tolerance for profiteering or price gouging in these essential drug markets.”

President Obama did sign an executive order this past October requiring the FDA to expedite regulatory reviews of drug manufacturers and investigate price gouging.

Building on the Executive Order in October, the White House also announced on Thursday that they will immediately begin requiring some drug manufacturers to report production interruptions to the FDA. The manufacturers that have to report to the FDA are those drug manufacturers that have no generic equivalent and are critical to maintaining life.

In addition, there are currently two bills before Congress that address the issue. But while Congress tries to create some sort of solutions, patients like Renee Mosier are forced to wait.

“You just don’t expect it to happen here."

Posted via email from Jack's posterous

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