LETTER TO AGRICULTURE APPROPRIATIONS CONFEREES AND
November 15, 2000
On behalf of national cancer survivor, provider, and research organizations, we are writing to express our deep reservations regarding the drug importation provision included in the FY 2001 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bill, P.L. 106-387.
While we support legislative efforts to improve individuals' access to prescription drugs, we do not believe this provision addresses the issue of patient access to drugs. We see no reason to believe that it will necessarily lead to a reduction in prices to consumers, as there is no requirement that lower costs be passed on to consumers or to payers like Medicare, Medicaid or private insurers. Moreover, the importation provision included by the Agriculture Appropriations bill may pose a health risk to all consumers and a special risk to individuals with cancer and other serious and life-threatening illnesses.
The process for approval of drugs and biologicals by the Food and Drug Administration (FDA) is often described by the Administration and the Congress as the international gold standard. This standard will be undermined by a system that encourages FDA to accept a lesser showing of safety and efficacy because the agency lacks the ability to police products through a consistent chain of custody placing responsibility on the manufacturer to maintain quality. Specifically, the concerns of the cancer community include the following:
For cancer patients, there is little margin for error in treatment. If cancer drugs are improperly handled and their safety and efficacy are compromised, patients cannot be assured that their treatment will be optimal. Our cancer specialists assert that they cannot ethically administer anti-cancer drugs if they are not assured that the potency of the drugs is intact and the drugs are not excessively toxic. The current review process ensures quality; the proposed system does not.
The recently-approved legislation would exempt parenteral drugs from coverage if the Secretary determines that their importation under this provision would pose a threat to public health. We request your assistance in assuring that the Secretary implements the law in such a manner that parenteral cancer therapies are excluded from coverage.
We also strongly recommend studies by experts to assess the potential pitfalls of this retreat from the usual standards of drug review in this country. The possible impact on people with cancer is too significant to be taken lightly by regulators or by Members of Congress.
Cancer Leadership Council
American Society of Clinical
© 2001-2002 Cancer Leadership Council. All rights reserved.