June 10, 2013
The Honorable Tom Harkin
U.S. Senate Committee on Health,
Education, Labor & Pensions
527 Hart Senate Office Building
Washington, DC 20510
The Honorable Lamar Alexander
U.S. Senate Committee on Health,
Education, Labor & Pensions
727 Hart Senate Office Building
Washington, DC 20510
Dear Chairman Harkin and Ranking Member Alexander:
On behalf of Trust for America’s Health (TFAH) and the American Public Health Association
(APHA), nonprofit, nonpartisan advocacy organizations dedicated to making disease prevention
a national priority, we write to express support for the Pharmaceutical Compounding Quality and
Accountability Act (S. 959). We look forward to working with you to strengthen this bill as it
moves through Congress.
TFAH and APHA have long advocated for shoring up America’s ability to prepare for and
respond to disasters and infectious disease outbreaks. However, prevention of outbreaks is the
most effective way to save lives. The fungal meningitis outbreak associated with medical
products from the New England Compounding Center in 2012 was a wakeup call that the Food
and Drug Administration needs additional authority to oversee high-volume compounding
facilities. Some of these facilities package and ship thousands of units of medicines to clinics
across the country, with no federal oversight. Therefore, a single point of contamination can
endanger patients nationwide, as we saw in the NECC outbreak and other recent events. These
activities go beyond state-regulated pharmacy compounding, and oversight may vary from state
to state.
S. 959 takes important steps to make Americans safer. It would bring compounding facilities
that ship interstate under federal regulation, which will allow for more uniformity of oversight
and safety standards. We believe the bill will give FDA the tools to ensure safe manufacturing
practices at these facilities. The legislation also protects the traditional role of pharmacists to
compound individual medicines for one patient at a time.
We do have some remaining concerns about shortcomings in the legislation. It does not address
large-scale compounding facilities that work and ship products within a single state. All
Americans, wherever they live, should have the same level of protection and reasonably expect
that federal protections should extend to all compounders, regardless of the geographic pattern of their sales. The bill also does not reach large, non-sterile compounding facilities. We hope these
areas are addressed in final legislation.
We thank you for your leadership and the opportunity to weigh in on this important legislation. If
you have questions, please do not hesitate to contact Dara Lieberman, TFAH’s Senior
Government Relations Manager, at 202-223-9870 ext. 20 or dlieberman@tfah.org, or Nicole
Burda, APHA’s Government Relations Manager, at 202-777-2513 or nicole.burda@apha.org.
Sincerely,
Georges C. Benjamin, MD, FACP, FACEP (E)
Executive Director
American Public Health Association
Jeffrey Levi, PhD
Executive Director
Trust for America’s Health
CC: Sen. Al Franken
Sen. Pat Roberts
The Honorable Tom Harkin
U.S. Senate Committee on Health,
Education, Labor & Pensions
527 Hart Senate Office Building
Washington, DC 20510
The Honorable Lamar Alexander
U.S. Senate Committee on Health,
Education, Labor & Pensions
727 Hart Senate Office Building
Washington, DC 20510
Dear Chairman Harkin and Ranking Member Alexander:
On behalf of Trust for America’s Health (TFAH) and the American Public Health Association
(APHA), nonprofit, nonpartisan advocacy organizations dedicated to making disease prevention
a national priority, we write to express support for the Pharmaceutical Compounding Quality and
Accountability Act (S. 959). We look forward to working with you to strengthen this bill as it
moves through Congress.
TFAH and APHA have long advocated for shoring up America’s ability to prepare for and
respond to disasters and infectious disease outbreaks. However, prevention of outbreaks is the
most effective way to save lives. The fungal meningitis outbreak associated with medical
products from the New England Compounding Center in 2012 was a wakeup call that the Food
and Drug Administration needs additional authority to oversee high-volume compounding
facilities. Some of these facilities package and ship thousands of units of medicines to clinics
across the country, with no federal oversight. Therefore, a single point of contamination can
endanger patients nationwide, as we saw in the NECC outbreak and other recent events. These
activities go beyond state-regulated pharmacy compounding, and oversight may vary from state
to state.
S. 959 takes important steps to make Americans safer. It would bring compounding facilities
that ship interstate under federal regulation, which will allow for more uniformity of oversight
and safety standards. We believe the bill will give FDA the tools to ensure safe manufacturing
practices at these facilities. The legislation also protects the traditional role of pharmacists to
compound individual medicines for one patient at a time.
We do have some remaining concerns about shortcomings in the legislation. It does not address
large-scale compounding facilities that work and ship products within a single state. All
Americans, wherever they live, should have the same level of protection and reasonably expect
that federal protections should extend to all compounders, regardless of the geographic pattern of their sales. The bill also does not reach large, non-sterile compounding facilities. We hope these
areas are addressed in final legislation.
We thank you for your leadership and the opportunity to weigh in on this important legislation. If
you have questions, please do not hesitate to contact Dara Lieberman, TFAH’s Senior
Government Relations Manager, at 202-223-9870 ext. 20 or dlieberman@tfah.org, or Nicole
Burda, APHA’s Government Relations Manager, at 202-777-2513 or nicole.burda@apha.org.
Sincerely,
Georges C. Benjamin, MD, FACP, FACEP (E)
Executive Director
American Public Health Association
Jeffrey Levi, PhD
Executive Director
Trust for America’s Health
CC: Sen. Al Franken
Sen. Pat Roberts
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