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Preventing Drug Shortages


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It has been a rough winter in many ways. Tons of snow and ice, widespread power outages and a worse than typical flu season. While the flu vaccine has helped keep many people from falling ill, it isn't 100 percent effective and many Americans still don't get their shot before the season starts.

With so many people getting sick, hospitals are finding that saline IV bags are in short supply. Saline bags are critical to getting patients the fluids they need. If you've been in the hospital, you probably were received some saline. Around 90 percent of patients are given one at some point in a hospital stay.

In recent years, drug shortages have been plaguing hospitals and doctors. The problem hasn't extended to common off-the-shelf medications, so you may not be aware of what is happening. However, Americans battling specific illnesses may find that the best drug for their treatment is unavailable. Drugs to treat cancer and to anaesthetize patients have been subject to shortages. Doctors typically find a replacement, but it may not be the most effective.

According to a University of Utah study, the number of drug shortage has increased from 154 in 2007 to 456 in 2012. While the number of new shortages being reported has gone down over the past two years, hundreds of drugs continue to be in short supply for a period of years.

Since I took over the direction of the Energy and Commerce Health Subcommittee, I've chaired three hearings to investigate the issue, the most recent on February 10.

In July of 2012, we passed the bipartisan Food and Drug Administration Safety and Innovation Act (FDASIA). This law contains provisions that give new authority and responsibilities to drug manufacturers and the FDA to work together to identify possible shortages. The law requires the FDA for the first time to compile a comprehensive list of shortages that is available to the public. It also creates a new task force at the agency to focus on the problem and to report to Congress about their work.

The law also requires pharmaceutical manufacturers to notify the FDA if they will stop making a life supporting drug or if they expect an interruption in manufacturing. Many critical drugs are only made at one site. If that location has to be shutdown for quality purposes then a shortage is inevitable.

It is good that a plant shuts down if there are concerns about the safety of the drugs that are being manufactured, but all too often the FDA was taking too long to inspect and clear sites. Sites that make unique drugs need to be opened back up as soon as they are ready. The law gives the FDA new authority to expedite drug applications and to prioritize the inspection of facilities.

The law also asked the Government Accountability Office to take a look at the problem. At our recent hearing, the Director of Health Care, Marcia Crosse testified about the state of drug shortages. The GAO reported that the FDA response has been improving, but there is still a long way to go. In 2012, the agency actively prevented 154 shortages as opposed to 2010 when only 35 shortages had been prevented.

These were positive signs, but the problem of drug shortages is not going to go away over night. If we want to expand access to health care, then we have to make sure that drugs are available to treat new patients. What good is insurance if you can't get treatment?

The drug shortage provisions in FDASIA were the result of bipartisan cooperation. I expect that we will continue working together across the aisle to make sure hospitals and pharmacies have the drugs they need to save lives.

The law is still relatively new and we're going to give the FDA time to implement our recommendations. If the industry and the government can work cooperatively and share information in good time, we can reduce shortages and ensure that they don't last very long.

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