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U.S. Department of Health and Human Services

Regulatory Information

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Talking with Stakeholders Summary of Proceedings

This meeting had 92 stakeholders in attendance. The meeting included formal presentations by health professionals, consumers and some industry representatives and general discussion from the floor. It provided an opportunity for stakeholders to articulate their concerns and share feedback on implementation of FDA's Modernization Act. The discussion centered around five key questions: What actions should FDA take to expand FDA's capability to incorporate state of the art science and risk based decision making? How can FDA facilitate the exchange and integration of scientific information to better enable the agency to meet its public health responsibilities? What actions can FDA take to educate the public in balancing risks and benefits in public health decisions? How can FDA and its related Centers focus resources in areas of greatest risk to the public health? What conditional actions do you propose for enhancing communication processes that allow for ongoing feedback and/or evaluation and evolution of FDA modernization efforts? Introductory Remarks Dr. Michael Friedman, Deputy Commissioner, FDA introduced the teleconference and stakeholder public meeting by saying that FDA is interested in hearing from stakeholders on how well FDA is implementing the FDA Modernization Act. He said the teleconference would be divided in two halves--the first half would be an opportunity for Drs. Henney and Suydam to articulate their vision for FDA and the second half would provide time for audience participation. After the teleconference, Mr. Robert Byrd, Deputy Commissioner for Management and Systems introduced stakeholder presenters. Along with Mr. Byrd, Dr. Friedman and Ms. Sharon Smith Holston (Deputy Commissioner for International and Constituent Relations) also participated as FDA panel members. Stakeholder Presentations Panels 1, 2 and 3 were intermingled with consumers, health professionals and industry representatives. The following organizations were represented: the American Herbal Products Association, the Annie Appleseed Project, the National Patient Safety Foundation, Children Afflicted by Toxic Substances, the Pharmaceutical Research and Manufacturers Association, the Committee of Ten Thousand, the Coalition for Regulatory Reform, Public Responsibility in Medicine and Research, the People's Medical Society, Susan Cohen and the American Society of Health Systems Pharmacists. The following are brief summaries of general concerns and issues raised at the April 28, 1999 Stakeholder Meeting held in Washington, D.C. More information is available in the transcript posted at www.fda.gov/oc/fdama/fdamawebcast/transcripts.html. Panel 1 American Herbal Products Association (AHPA) Tony Young said AHPA supports the concept of risk-based decision making and the incorporation of all available science including state-of-the-art science into the process. AHPA encouraged FDA to provide information to them as it becomes available for incorporation in the Botanical Safety Handbook. Annie Appleseed Project Ann Fonfa is a breast cancer patient and advocate and said that cancer patients are concerned about treatment options and standards and that cancer patients need to know about all available clinical trials. She said that standards for healthy people will need to be different from those who are ill in order to see if survival is impacted by the drugs under study. She said drug approval standards are both inappropriate and tertiary and tumor reduction doesn't often correlate with increased survival. She urged the study of natural and nontoxic substances as quickly as possible. National Patient Safety Foundation Eleanor Vogt said that institutions and the companies involved in therapy product research are rich sources of product and disease state information and that the National Patient Safety Foundation is working actively with FDA to systematically look at the roles and accountability of those involved in the pharmaceutical safety chain. She suggested that we begin to develop a transformational or practice model for the next generation of products and that FDA formally request NPSF to convene the proper forum to begin this dialogue. Children Afflicted by Toxic Substances Jama Russano said she found a general lack of information concerning the safety of medical devices and other products that had routine exposure to kids. She said that FDA is recognized as a safety net for consumers and that the agency must place the consumer before the manufacturer at all times. She said that FDA should charge a user fee from seven to ten percent and that strong fines should be imposed when a product line has to be reviewed or taken off the market due to adverse reactions. She said the regulated industry manages the media which in turns gives consumers misleading information. General Discussion: There was general discussion about efficacy testing of herbs in Asia and the recognition factor of FDA around the country. Panel 2 PhRMA Bert Spilker said that risk-based decision making should never be undertaken except in comparison to benefits. He also said PhRMA supports FDA's need to have the most scientifically competent staff possible. PhRMA believes that FDA and industry should educate the public that drug safety is best viewed as a balance of risks and benefits and that prescription drug benefits outweigh their risks. Committee of Ten Thousand Dana Kuhn, who has hemophilia and is coinfected with HIV and HCV, said that more priority should be given to post market surveillance of adverse reactions to the AIDS drugs. He said that given the harsh adverse reactions of these drugs, that better monitoring and tracking is necessary and is not considered a enough of a funding priority. Coalition for Regulatory Reform Anita Ducca said that CFRR supports FDA's desire to utilize the state of the art science in its risk-based decision-making processes and that product review and approval times can have a direct impact on the availability of life saving products. To increase its scientific resources, FDA could enhance collaboration with domestic and international health organizations. They also recommended expanding interactions with domestic health organizations and regulated industry. As part of its risk based resource assessment, FDA could develop a systems based approach inspection program in order to provide greater focus on important safety and quality steps within the manufacturing sites. Public Responsibility in Medicine and Research Sanford Chodosh said that very often industry plans and carries out studies in both the research and marketing divisions and that the protocols, for the most part, reflect FDA's minimum standards to obtain approval. He said that FDA should not accept equivalence testing as an acceptable standard, but instead look for existing differences in drug testing. The methodology should be the best objective measure of what is expected of the compound and FDA needs to set a higher standard for the science of drug and device review. Industry needs to develop therapies that are properly tested and human subjects must be informed of study results. All significant study results, whether positive or negative, should be broadly reported. General Discussion: A question was raised about whether the Red Cross accepts blood from people with immune deficiencies or severe allergic reactions. Ms. Ducca responded that there is an extensive donor screening process that tends to focus on lifestyle and/or whether the donor has any transmissible diseases. Panel 3 People's Medical Society Michael Doneo said his group is generally supportive of FDAMA, but that they have reservations about the expediency of bringing certain products to the market because of the potential adverse reactions. Consumer Advocate Susan Cohen said that the agency's ability to disseminate information must be enhanced by upgrading its computers and employee training to stay abreast of current technology. She said that consumers should not rely on drug manufacturers to provide consumer education through direct to consumer advertising and that it should be a top priority for FDA to provide this education. She also said there should be a well funded consumer hotline in FDA for consumers to report adverse reactions. She said that new drugs should be given provisional status for the first year after approval. American Society of Health Systems Pharmacists Brian Meyer said there is a need to better educate the public on safety risks associated with prescription drug use. ASHP would like to begin a partnership with FDA, health professionals and patients to study error prevention through collaborative drug therapy management. He also said that FDA should review the concept of direct to consumer advertising more critically. General Discussion: A comment was made that FDA should emphasize that only drug doses approved for specific indications mentioned in the package insert are FDA approved uses of the drug and that FDA has no written guideline to evaluate the safety of drugs used in pregnant women. One person voiced concern about the lack of physician representation on advisory panels. It was suggested that consumer groups should be working with FDA to report adverse reactions with cosmetics and processed foods. Concluding Remarks Sharon Smith Holston concluded by expressing FDA's appreciation to those stakeholders who participated in this meeting. She said that stakeholders wanted FDA to make decisions based on the best available science, but that they also wanted FDA to communicate this information rapidly and effectively. She said there were concerns expressed about rapid approval of drugs and FDA's ability to monitor adverse effects through post market surveillance. There were concerns expressed about providing better education on the benefits and risks of drugs. She said that she thought everyone was supportive of more proactive communication between FDA and stakeholders and there was recognition that FDA has limited resources and there are many organizations who want to help FDA obtain those necessary resources. She said that FDA would be holding more stakeholder meetings in the future, not only because of FDAMA, but because FDA is truly interested in gaining stakeholder input into how the agency does business.

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