CLC Policy Issues: FDA

CLC offers comments on House Energy & Commerce Committee Track and Trace Legislation
(May 14, 2013)

May 14, 2013

The Honorable Fred Upton Chairman Committee on Energy and Commerce House of Representatives Washington, D.C. 20515	The Honorable Henry Waxman Ranking Member Committee on Energy and Commerce House of Representatives Washington, D.C. 20515
The Honorable Joseph Pitts Chairman Subcommittee on Health Committee on Energy and Commerce House of Representatives Washington, D.C. 20515	The Honorable Frank Pallone Ranking Member Subcommittee on Health Committee on Energy and Commerce House of Representatives Washington, D.C. 20515

Dear Chairman Upton, Ranking Member Waxman, Chairman Pitts, and Ranking Member Pallone:

The undersigned organizations representing cancer patients, physicians, and researchers are writing in support of efforts to develop legislation to protect the security of the pharmaceutical distribution supply chain.

Cancer patients and physicians have experienced the adverse effects of disruptions in the supply chain and the counterfeiting of cancer drugs, occurrences which can compromise the quality of care they receive and the effectiveness of their treatments. Patients and their physicians must be able to trust that the drugs they prescribe and receive are consistent with their labeling. In the past, cancer patients have received counterfeit drugs that were ineffective. In those circumstances, cancer patients were harmed by time wasted receiving therapies that provided no medical benefit.

As you continue your work on supply chain protections, we urge that you develop a supply chain protection system that:

•    Includes participation by all those involved in the supply chain;
•    Requires traceability of drugs at the smallest unit level; and
•    Facilitates routine verification of drug serial numbers.

We also urge that existing state drug pedigree laws not be preempted until a strong national system is implemented. Eliminating state protections without a national system to replace them would not be in the best interest of cancer patients and other Americans who trust that the medications they are prescribed are safe and effective.

We understand that developing a strong supply chain protection system will be accompanied by some costs. However, the health care system and patients are already bearing the costs associated with diversion and counterfeiting. Diversion schemes can cost health care payers significant sums. Money is wasted on counterfeit medicines, and additional resources must be spent on the therapies that patients may need to address the harm and/or lack of effectiveness of counterfeit drugs. Companies that have been victims to counterfeiting or diversion may bear significant costs as a result. Finally, the human costs of counterfeiting and diversion are great, as patients may be harmed by unsafe or ineffective medications.

We commend your commitment to addressing the safety of the pharmaceutical distribution system and urge you to develop protections that are adequate to meet the needs of cancer patients and their physicians.

Sincerely,

Cancer Leadership Council

American Society for Radiation Oncology
American Society of Clinical Oncology
Bladder Cancer Advocacy Network
Cancer Support Community
The Children's Cause for Cancer Advocacy
Coalition of Cancer Cooperative Groups
Fight Colorectal Cancer
International Myeloma Foundation
Kidney Cancer Association
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
National Lung Cancer Partnership
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen for the Cure Advocacy Alliance

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