Summary of Testimony of Jim Guest
President, Consumers Union, Independent non-profit publisher of
before the Subcommittee on Health, Committee on Energy and Commerce
U.S. House of Representatives
June 12, 2007
On PDUFA, Risk Evaluation & Mitigation Strategies, Clinical Trials, and Advisory Committee Conflicts
Consumers Union is the independent, non-profit publisher of Consumer Reports. For over two years we have been conducting a Prescription for Change campaign to strengthen the prescription drug safety system at both the state and national level.
This is not a dry and abstract issue: it is a matter of life and death. In the hearing room today are families and individuals who have suffered from what we believe are adverse drug events that could have been avoided if we had stronger laws.
We endorse Chairman Pallone’s REMS, Clinical Trials, and Conflicts discussion drafts. The REMS provisions include a notice to consumers of when a drug is newly on the market, provide for huge automated analysis of medical databases to detect short- and long- term drug safety problems, and give the FDA a tool chest of authorities to ensure faster action on safety issues (such as effective authorities in the areas of labeling, studies, drug distribution and communication and advertising strategies). More meaningful penalties will help ensure these reforms are taken seriously. The Clinical Trials draft ensures registration of phase 2-4 trials and full disclosure of their results. The PDUFA draft will give the FDA needed safety resources and open up future PDUFA negotiations to public participation.
We hope more can be done in this legislation to ensure scientific integrity and openness in the FDA, through the full disclosure of FDA action letters on drug applications, the right of staff to publicly note dissents and disagreements, the right to publish in scientific journals, and protection for the use of those rights.
We support increasing the status and authority of the office of drug safety so there is a locus of responsibility for safety issues. Senator Grassley’s floor amendment #1039 is an example of how this can be done without causing bureaucratic delay or disruption.
We support the clinical trials registration and results reporting provisions, and ask that the International Conference of Medical Journal Editors recent proposal to require registration of Phase 1 trials can be adopted. We recognize that regulations need to be issued to ensure the honest and unbiased reporting of clinical trials, but urge that the discussion draft language outlining this reporting be retained. We support the automatic pre-clearance of all DTC ads and the authority for temporary delay in mass advertising of drugs with unknown but potentially serious side effects. We urge the Advisory Committee conflict-of-interest provisions be strengthened to eliminate all conflicts and recruit a wider diversity of conflict-free advisors.