October 19, 2005
The Honorable Edward M. Kennedy
United States Senate
Washington, DC 20510
Dear Senator Kennedy:
Consumers Union, the independent, non-profit publisher of Consumer Reports, deeply appreciates the work of the Health, Education, Labor and Pensions Committee to prepare better for biomedical disasters, such as an Avian Flu pandemic. This may indeed be one of the most critical public health issues of our time.
We urge, however, that as you consider the “Biodefense and Pandemic Vaccine and Drug Development Act of 2005,” that you consider a number of pro-consumer changes.
In addition to our serious concerns about the elimination of most liability protections for injured parties, Consumers Union is deeply troubled by the bill’s patent changes which may further fuel drug price inflation. We urge that Congress use direct incentives, rather than patent law protections, to encourage the development, production, and stockpiling of new medical defenses, and not use patent laws to further encourage such development. In the past twenty years, a number of steps have been taken to extend patent life and market exclusivity. Some of these changes have helped encourage the development of new, rare disease drugs. Yet the industry spends most of its effort and the money from its monopoly patents in developing ‘me-too’ drugs that bring little new to medical science, while prescription drug inflation continues at three or more times the general rate of inflation, year after year.
We hope that new ways can be found to protect public health and encourage biodefense and pandemic defenses without consumer price gouging—such as through direct grants, prizes, and guaranteed purchase of necessary stockpiles. History has shown that patent and market exclusivity extensions all too often spill over into monopoly profits, legal manipulations, and outrageous pricing that adds little to the public’s health.
In addition, we hope that in the National Biodefense Advisory Board some consumers could be included. We also urge you to include a provision for immediate and long-term adverse event monitoring by the FDA. It is essential that we understand the pros and cons and side effects of any mass inoculation or preventive measure. Currently, the FDA system is passive, with the agency waiting for reports from doctors, patients, and companies. It is essential in future emergencies that more complete data about harmful effects of courses of treatment are available immediately, so that national treatment campaigns can be adjusted accordingly.
Thank you for your consideration of these views as you work on this important legislation.
Sincerely,
William Vaughan
Senior Policy Analyst