Contact: Shana Stribling 202.224.0309 Sarah Ross 202-224-4774
Thursday, October 23, 2003

WASHINGTON, DC Senators Kit Bond (R-MO) and Pat Roberts (R-KS) today held the first in a series of hearings in the Senate Health, Education, Labor, and Pensions (HELP) Committee on the safety and quality of compounded drugs.

"When people get sick they want to know that their medicine is safe and effective – and most importantly just what the doctor ordered," said Senator Bond who chaired the hearing. "My goal is not to federalize the oversight of pharmacies and compounding pharmacists, or institute additional, needless and burdensome paperwork and regulatory requirements. But the issue at hand is clear. We have a responsibility to ensure that patients and doctors are receiving safe and accurate dosages of compounded drugs."

“Unfortunately in the compounding industry we have more questions than answers about wether proper checks and balances are in place to protect patients,” Senator Roberts said. “I fully recognize the benefits of compounding pharmacy and they fill an important niche in the health care delivery system. However, what are we doing at the state level to enforce regulations currently on the books? Should we have a means to test products once they have been compounded to ensure they are safe and accurate doses? Why is there not a system of adverse event reporting? I hope these hearings will address these concerns.”

The hearing examined the growth of drug compounding and assessed the adequacy of regulatory oversight. Currently, the Food and Drug Administration (FDA) does not require pharmacies to report adverse events associated with compounded drugs. Based on voluntary reporting, media reports and other sources, FDA has become aware of over 200 adverse events involving 71 compounded products since 1990. These incidents, including 3 deaths and 13 hospitalizations following injection of a compounded drug that was contaminated with bacteria in 2001, have heightened concern about compounded drugs’ safety and quality. In addition, a limited survey conducted by FDA’s Division of Prescription Drug Compliance and Surveillance in 2001 found that nearly one-third of 29 sampled drugs were subpotent – that is, they had less of the active ingredients than indicated.

Witnesses testifying before the committee included: Janet Heinrich, DrPH, RN, Director of Health Care-Public Health Issues at the U.S. General Accounting Office, Steven Galson, MD, MPH, Deputy Director, Center of Drug Evaluation and Research at the Food and Drug Administration, Sarah Sellers, PharmD, Executive Director, The Center for Pharmaceutical Safety, Daniel A. Herbert, Rph President Elect American Pharmacists Association, Kevin Kinkade, RPh, Executive Director Missouri Board of Pharmacy, William Kennedy, RPh and Owner, Nephron Pharmaceuticals Corporation.

In June, Senators Bond, Roberts and Judd Gregg (R-NH), the Chairman of the Senate HELP Committee, requested a General Accounting Office (GAO) report that would examine issues surrounding the size, scope and practice of drug compounding. In addition to the GAO study, Bond-Roberts won U.S. Senate approval to create an advisory "Committee on Drug Compounding" at the U.S. Food and Drug Administration to ensure that patients are receiving necessary, safe and accurate dosages of compounded drugs.

Senators Bond and Roberts are both key members of the Senate Health, Education, Labor and Pensions Committee.