Is Drug Approval Moving Forward?
May 26, 2005
A recent Wall Street Journal editorial entitled “The FDA vs. Cancer Patients” raised concerns within the pediatric cancer community. The article indicated a concern with the recent unusual denial by the Oncologic Drugs Advisory Committee (ODAC) to approve Johnson & Johnson’s leukemia drug Zarnestra.
Another concern has been the failure of the FDA to appoint a new commissioner after Mark McCellan, former commissioner, changed jobs. Among its many roles, the FDA oversees incentive programs such as the orphan drug law. The orphan drug law provides tax breaks and seven years of marketing exclusivity to companies developing drugs for unmet medical needs affecting relatively small populations. These issues may not be addressed without a permanent person in the role of commissioner.
The cancer community is also expressing concerns regarding drug companies’ interest in testing cancer prevention drugs. This issue recently surfaced when drug makers of statins, cholesterol-lowering drugs, were not interested in testing the drugs for cancer prevention. Cancer prevention testing can take over a decade to complete which can be problematic for newly approved drugs with unknown long term effects. Currently, the link between possible cancer prevention and any of these drugs is largely circumstantial.
Further education of current legislation, concerns in the oncology community and the people who impact areas such as drug approval will enable you to be a better advocate for issues related to cancer.
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May 26, 2005
A recent Wall Street Journal editorial entitled “The FDA vs. Cancer Patients” raised concerns within the pediatric cancer community. The article indicated a concern with the recent unusual denial by the Oncologic Drugs Advisory Committee (ODAC) to approve Johnson & Johnson’s leukemia drug Zarnestra.
Another concern has been the failure of the FDA to appoint a new commissioner after Mark McCellan, former commissioner, changed jobs. Among its many roles, the FDA oversees incentive programs such as the orphan drug law. The orphan drug law provides tax breaks and seven years of marketing exclusivity to companies developing drugs for unmet medical needs affecting relatively small populations. These issues may not be addressed without a permanent person in the role of commissioner.
The cancer community is also expressing concerns regarding drug companies’ interest in testing cancer prevention drugs. This issue recently surfaced when drug makers of statins, cholesterol-lowering drugs, were not interested in testing the drugs for cancer prevention. Cancer prevention testing can take over a decade to complete which can be problematic for newly approved drugs with unknown long term effects. Currently, the link between possible cancer prevention and any of these drugs is largely circumstantial.
Further education of current legislation, concerns in the oncology community and the people who impact areas such as drug approval will enable you to be a better advocate for issues related to cancer.
<< Back
