Drug & Device News

Altered Warning Recommends Modest Dosing of Anemia Drugs

The U.S. Food and Drug Administration has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absolutely necessary. The agency has determined that when ESAs are used to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis.

The U.S. Food and Drug Administration (FDA) has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absol'd to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis. Marketed under the names Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa), ESAs approved to treat anemia in patients with chronic kidney disease were specifically identified in the June 24 FDA release describing the altered package warnings. In announcing the changes, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research said, “Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risk. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

DEA Answers Petitioners: Marijuana Is Not Medicine

Nine years ago, the Coalition for Rescheduling Cannabis (CRC) petitioned the federal government seeking to get marijuana reclassified as medicinal. On July 9, the Drug Enforcement Administration (DEA) published its answer to the petitioner's request in the federal register: The DEA concluded that no reclassification is warranted because the federal government does not accept that there is any legitimate medical use for marijuana. The CRC is a group composed of many smaller groups and individuals that have banded together to get marijuana rescheduled on the DEA's list of controlled substances. The CRC and Americans for Safe Access (ASA) (another advocacy group in favor of making marijuana legal for medicinal purposes) filed an appeal to the U.S. Court of Appeals for the D.C. Circuit two weeks later. In a release announcing that appeal, ASA Chief Counsel Joe Elford stated, “By ignoring the wealth of scientific evidence that clearly shows the therapeutic value of marijuana, the Obama Administration is playing politics at the expense of sick and dying Americans.”

FDA Answers Question: When Is New Premarket
Review Required?

The FDA released a draft guidance July 26 outlining its new premarket review expectations and procedures for modifications to medical devices that have already been approved under the 501(k) process. The process is the most common review path to market for low-risk medical devices that are substantially equivalent to another, already approved, medical device. By clarifying which changes to products need to be submitted to the FDA, the new premarket review standards are expected to make it easier for manufacturers to upgrade and modify devices already on the market. In a release, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, explained, “We are making the regulatory process for medical devices less challenging by better describing our expectations.” For more information, go to: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm.

Altered Warning Recommends Modest Dosing of Anemia Drugs

The U.S. Food and Drug Administration has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absolutely necessary. The agency has determined that when ESAs are used to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis.

The U.S. Food and Drug Administration (FDA) has altered the Boxed Warnings and other enclosed literature in the packaging of Erythropoiesis-Stimulating Agents (ESAs) to indicate that, for safety reasons, they should only be used when absol'd to treat anemia in patients with chronic kidney disease, those individuals are at increased risk of suffering adverse cardiovascular events, including stroke and thrombosis. Marketed under the names Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa), ESAs approved to treat anemia in patients with chronic kidney disease were specifically identified in the June 24 FDA release describing the altered package warnings. In announcing the changes, John Jenkins, MD, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research said, “Health care practitioners should carefully consider when to begin treatment with an ESA and actively monitor dosing in patients with chronic kidney disease, keeping in mind the increased risk for serious cardiovascular events, and should talk to their patients about these potential risk. The goal is to individualize therapy and use the lowest ESA dose possible to reduce the need for red blood cell transfusions.”

DEA Answers Petitioners: Marijuana Is Not Medicine

Nine years ago, the Coalition for Rescheduling Cannabis (CRC) petitioned the federal government seeking to get marijuana reclassified as medicinal. On July 9, the Drug Enforcement Administration (DEA) published its answer to the petitioner's request in the federal register: The DEA concluded that no reclassification is warranted because the federal government does not accept that there is any legitimate medical use for marijuana. The CRC is a group composed of many smaller groups and individuals that have banded together to get marijuana rescheduled on the DEA's list of controlled substances. The CRC and Americans for Safe Access (ASA) (another advocacy group in favor of making marijuana legal for medicinal purposes) filed an appeal to the U.S. Court of Appeals for the D.C. Circuit two weeks later. In a release announcing that appeal, ASA Chief Counsel Joe Elford stated, “By ignoring the wealth of scientific evidence that clearly shows the therapeutic value of marijuana, the Obama Administration is playing politics at the expense of sick and dying Americans.”

FDA Answers Question: When Is New Premarket
Review Required?

The FDA released a draft guidance July 26 outlining its new premarket review expectations and procedures for modifications to medical devices that have already been approved under the 501(k) process. The process is the most common review path to market for low-risk medical devices that are substantially equivalent to another, already approved, medical device. By clarifying which changes to products need to be submitted to the FDA, the new premarket review standards are expected to make it easier for manufacturers to upgrade and modify devices already on the market. In a release, Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, explained, “We are making the regulatory process for medical devices less challenging by better describing our expectations.” For more information, go to: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm265458.htm.