Cape Gazette
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Country needs Drug Shortage Prevention Act

By John Carney | Feb 07, 2012

Not long ago, I had a meeting with a group of cancer doctors from Delaware. What they told me was shocking. They said that across the country, prescription drug shortages are preventing patients from getting the treatment they need to effectively fight cancer and other life-threatening diseases.

I heard stories of patients who are unable to get the chemotherapy drugs they need, while others are being forced to use some of the most expensive drugs on the market because the cheaper, generic version is in shortage. I heard about a doctor who didn’t know about a shortage of Propofol, the most commonly used anesthesia drug, until he needed it on the operating table. And my office heard from a Delawarean who couldn’t get the prescription she needed at her local pharmacy – or any pharmacy in the region.

Critical prescription drug shortages have skyrocketed in recent years. In 2005, there were 61 different drugs nationwide that had serious shortages. In 2010, that number increased to 178, and last year it eclipsed 230. Cancer drugs, anesthesia drugs, and nutrition medicines have been hit the hardest.

Since my meeting with the cancer doctors, I have been working on legislation to address this crisis and help patients get the medicine they need. Last week, I introduced the Drug Shortage Prevention Act in the U.S. House of Representatives with my colleague, Rep. Larry Bucshon, a Republican doctor from Indiana.

Until now, the response to critical drug shortages has been reactive, waiting until a problem occurs to address it. The Drug Shortage Prevention Act will force the Food & Drug Administration to work with pharmaceutical companies and the medical community to address issues in the production and distribution of prescription drugs before they begin impacting patients. Specifically, the bill spells out five changes to the current process:

First, the bill requires FDA and drug companies to come together to determine which drugs are in danger of going into shortage, and then to identify those vulnerable drugs on a list for relevant stakeholders, like doctors and pharmacists.

Second, the bill mandates that FDA expedite the review of applications by any manufacturer who is looking to produce drugs on the potential shortage list. In addition, the FDA would expedite the review of requests by manufacturers who already produce vulnerable drugs to make changes to their supply chain in order to boost production.

Instead of reviewing applications on a first-come, first-served basis, my legislation would put vulnerable drugs at the front of the line. Speeding up the review process, while still ensuring product safety, will help get needed drugs onto the market sooner.

Third, the legislation gives the FDA more flexibility in addressing manufacturing problems. Right now, if even a small issue is identified at a drug manufacturing facility, the entire plant may be shut down, temporarily stopping production of all the drugs made at that plant. The Drug Shortage Prevention Act would require FDA to take a more measured approach and correct issues by shutting down the part of the plant where the problem occurred, as opposed to taking the entire facility offline.

Fourth, FDA would be required to develop a notification system so that doctors, patients, and family members have time to evaluate their options when a drug shortage is expected.

Finally, the bill would require the Drug Enforcement Administration to raise manufacturing quotas for drugs that are in short supply so that drug companies can start pumping needed supply back onto the market.

My legislation does not fix all of the problems that are causing drug shortages. But America is currently experiencing a drug shortage crisis, and we do not have any time to waste before tackling this problem.

That’s why my bill makes simple, yet fundamental changes that could be implemented quickly – and without partisan wrangling – to slow the tide of current shortages and prevent future ones.

When a family gets hit with a diagnosis like cancer, they have enough things to worry about. Running out of chemotherapy drugs should not be one of those things.

John Carney is the United States representative from Delaware.

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