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Hearing of the Health Subcommittee of the House Energy and Commerce Committee - "Examining the Increase in Drug Shortages"

Statement

By:
Date:
Location: Washington, DC

In 2005, 61 drug shortages were reported to FDA. By 2010, there were 178 reported drug shortages, 132 of which involved sterile injectable drugs.

So far this year, FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs. These shortages have involved cancer drugs, anesthetics used for patients undergoing surgery, as well as drugs needed for emergency medicine, and electrolytes needed for patients on IV feeding.

It appears that there are many potential causes of these drug shortages.

In some cases, shortages have been caused by quality and manufacturing issues.

Additionally, production delays at the manufacturer level, including limited production lines for certain older drugs, and difficulty in receiving raw materials and components from suppliers have caused drug shortages. Many raw material suppliers also experience capacity problems at their facilities, causing delays that ripple through the drug production process.

Shortages can also result from a company discontinuing a particular drug. Certain drugs are susceptible to shortages, particularly those that are complex to manufacture, such as injectable drugs, or require longer lead times.

FDA cannot compel a company to manufacture a particular drug, and, if there is a shortage of that drug, it cannot compel other firms to increase their capacity.

Further, companies are not required to notify FDA in advance of a potential drug shortage, unless a company is discontinuing a sole source, medically necessary drug. In that case, a company must inform FDA six months in advance.

Drug shortages have real effects on real patients. Due to shortages, patients have not received the appropriate drugs for their conditions, often getting a less effective drug or a more costly substitute as result.

According to a study done by Premier healthcare alliance of 228 hospitals, retail pharmacies, and other health care facilities, nearly 90 percent of hospitals reported a drug shortage in the last half of last year that may have caused a patient safety issue, resulted in a procedure's delay or cancellation, required a more expensive substitute, or resulted in a pharmacist compounding a drug.

I look forward to hearing from our witnesses today about their experiences with drug shortages
and learning what remedies they believe are necessary.

I would like to say a special hello to Richard Paoletti, Vice President, Operations -- Pharmacy, Laboratory, and Radiology at Lancaster General Hospital in my home district.

Lancaster General is the largest employer in the 16th Congressional District, and, for 10 of the past 13 years, it has been named among the "Top 100 Hospitals in America" by Thomson Reuters, a leading source of health care business intelligence.

The hospital is also helping to revitalize the northwestern part of Lancaster City through a partnership with Franklin and Marshall College.

Again, thank you to our witnesses.


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