Hearing Description:
The House Committee on Energy and Commerce, Health Subcommittee convened to examine how often and how badly drug shortages were affecting patient care and what steps the FDA has taken to get ahead of the problem. The agency has been working with industry to gather better data and to help manufacturers better their processes as well receiving notification of shortages before they actually occur.
Hearing Date: February 10th, 2014
Hearing Summary: Prepared for AAPS by the Market Institute
The House Health subcommittee met to examine the dramatic increase of drug shortages in the United States. The total number of ongoing shortages has continued to increase until 2012, when the problem seems to have been stemmed. Chairman Joe Pitts (R-PA) said in his opening statement that even generic drugs are facing shortages. The subcommittee realizes the challenges facing this problem. During the last Congress, the subcommittee passed legislation that included expanding the powers of the FDA and making manufacturers report when they could face shortages.
The first witness, Marcia Crosse, Ph.D. Director at the Health Care U.S. Government Accountability Office testified in her opening statement that they found that the number of drug shortages remains high and that providers experience challenges responding to drug shortages without adversely affecting patient care. Provider association representatives told us that a number of the challenges that we reported in 2011 were still relevant for their members. They determined that the most frequently cited immediate cause of a drug shortage was when a manufacturer halted or slowed production after a quality problem was identified, resulting in a supply disruption. half of the studies they reviewed suggested that the immediate causes of drug shortages, such as quality problems, are driven by an underlying cause that stems from the economics of the generic sterile injectable drug market. Lastly, the FDA has prevented more potential shortages and improved its ability to respond to shortages since they issued their prior
report on the topic in 2011.
The final witness, Douglas Throckmorton, Deputy Director of Regulatory Programs at the FDA testified in his opening statement that the FDA is prepared to respond to a drug shortage, provided that they are made aware by manufacturers a shortage is coming. The drug shortages are not just relegated to hard to come by drugs. There was a recent report of a saline drug shortage which has the potential to delay care for patients. Drug shortages remain a top priority for the FDA. However, the FDA alone cannot solve the problems currently being faced. Collaboration among government and private business is vital to combating drug shortages.
In response to questioning, Marcia Crosse said:
- The new databases will be critical in the FDA being able to measure whether they are having an impact on drug shortage situations
In response to questioning, Douglas Throckmorton:
- The previous legislation has unquestionably been useful, particular the ability to talk to manufacturers about shortages
- The current set of standards is working; there are more efficient processes that drug manufacturers could use
- Economics should be playing a role in the decisions manufacturers make
Hearing Website:
http://energycommerce.house.gov/hearing/examining-drug-shortages-and-recent-efforts-address-them
Links to Testimony:
Marcia Crosse, Ph.D. Director, Health Care U.S. Government Accountability Office
Click to access HHRG-113-IF14-Wstate-CrosseM-20140210.pdf
Douglas Throckmorton, M.D. Deputy Director of Regulatory Programs U.S. Food and Drug Administration
Click to access HHRG-113-IF14-Wstate-ThrockmortonD-20140210.pdf
