Casey, Harkin, Blumenthal Request GAO Study on Drug Shortages

WASHINGTON, DC— In response to reports of frequent shortages of life-saving pharmaceutical products at hospitals around the country, U.S. Senators Bob Casey (D-PA), Tom Harkin (D-IA) and Richard Blumenthal (D-CT) today called on the U.S. Government Accountability Office (GAO) to conduct a study on drug shortages in the United States.

“Patients should not be put at risk because of drug shortages,” said Senator Casey. “We need detailed information about the causes of these shortages to be able to prevent them from occurring in the future.”

“These shortages directly threaten public health by preventing patients from accessing medications that are essential to their care,” the Senators wrote. “The difficulty that hospitals encounter in securing an adequate supply of critical drugs forces doctors to ration their supply of medication, delay medical procedures, and use alternative products that may carry with them unwanted side effects or be unfamiliar to the physicians prescribing them.”

In their letter to GAO Comptroller General Gene L. Dodaro, the Senators urged the GAO to examine how the FDA identifies and responds to drug shortages and to identify what steps the FDA could take under its current authority to better identify and resolve drug shortages.

“Shortages of generic injectable medications have become a daily challenge for tens of thousands of health care providers across the USA,” said Dwight Kloth, Director of Pharmacy at Fox Chase Cancer Center in Philadelphia. “It is vital that any and all possible solutions to mitigate or prevent these shortages be explored and I applaud the Senators’ request to the non-partisan GAO to provide their analytical expertise to identify ways in which government, industry and all other health care stakeholders can work together to solve this severe and ongoing threat to public health in the United States.” 

“Critical drug shortages of life-saving medications pose a significant threat to patient care in PA and throughout the world,” said Richard D. Paoletti, Vice President of Operations for Lancaster General Health. “Healthcare providers and specifically, pharmacists have been inundated with additional unnecessary logistical responsibilities to minimize these impacts, taking precious resources away from more critical direct patient care activities.  Lancaster General Health endorses and appreciates the support of Senator Casey’s office in working on this issue.”


A copy of the letter is below:

Dear Mr. Dodaro:

We write to request that GAO conduct a study on drug shortages in the United States.

We have met with a variety of stakeholders who report that hospitals around the country are experiencing frequent shortages of life-saving FDA-approved pharmaceutical products.  These shortages directly threaten public health by preventing patients from accessing medications that are essential to their care.

According to published reports, data gathered by the American Society of Health-System Pharmacists show a dramatic increase in the number of drugs that were in short supply in 2010:  148 different drugs, up substantially from 50 drugs just four years earlier.

The difficulty that hospitals encounter in securing an adequate supply of critical drugs forces doctors to ration their supply of medication, delay medical procedures, and use alternative products that may carry with them unwanted side effects or be unfamiliar to the physicians prescribing them.  In many instances, drug shortages also compel medical practitioners to rely on foreign versions of drugs that have not been reviewed by FDA and approved for use in the United States.

In order to help us better understand the problem of drug shortages, we request that GAO conduct a study to examine the following:

1) How does FDA identify and respond to drug shortages? What regulatory tools and authority does FDA have at its disposal? 
2) What causes drug shortages?  Are they the result of manufacturing problems by industry?  Are they caused by breakdown in the supply chain delivery system? Are regulatory requirements a factor?
3) Is there adequate communication between industry, FDA, and medical practitioners about drug shortages and potential responses?  Does FDA or industry provide notice to the medical community when a shortage is anticipated?
4) What steps, if any, could FDA take under its current authority to better identify and ameliorate drug shortages?  What additional authority, if any, is needed to help prevent and address drug shortages?

Thank you for your attention to this request.


Sincerely,

Tom Harkin
Chairman, Senate HELP Committee

Robert P. Casey, Jr.
United States Senator

Richard Blumenthal
United States Senator

                                                           
###