U.S. health regulators said drugmakers Celgene Corp and Novartis AG misrepresented their cancer drugs to doctors, overstating how well the medicines target tumors without having evidence to support it.
The complaints concern Celgene's breast cancer drug Abraxane (paclitaxel injection) and Novartis's cancer drug Gleevec (imatinib).
The Food and Drug Administration has posted separate letters to each company on its website, asking them to stop using advertising that violates FDA guidelines.
The FDA said Celgene also broadened the uses for Abraxane and omitted safety information in a paper displayed at the American Society of Clinical Oncology meeting in 2010.
Celgene spokesman Greg Geissman said the paper was produced and distributed by Abraxis, the original manufacturer of Abraxane. Celgene acquired Abraxis later in 2010.
"Celgene has never distributed the paper, and it has been discontinued from use," Geissman said. "We are working with (the FDA) to rectify all their concerns."
For Novartis, the FDA focused on a "Case Highlights" document that described how well Gleevec worked for a particular patient. The FDA said this was misleading because the document implied the drug would work just as well for other patients.
"A selected case study of one patient's treatment response does not constitute substantial evidence," the agency said in the letter.
The FDA's letter to Celgene appears at http://1.usa.gov/w2HyGk, and its letter to Novartis is at http://1.usa.gov/w2HyGk,
The complaints concern Celgene's breast cancer drug Abraxane (paclitaxel injection) and Novartis's cancer drug Gleevec (imatinib).
The Food and Drug Administration has posted separate letters to each company on its website, asking them to stop using advertising that violates FDA guidelines.
The FDA said Celgene also broadened the uses for Abraxane and omitted safety information in a paper displayed at the American Society of Clinical Oncology meeting in 2010.
Celgene spokesman Greg Geissman said the paper was produced and distributed by Abraxis, the original manufacturer of Abraxane. Celgene acquired Abraxis later in 2010.
"Celgene has never distributed the paper, and it has been discontinued from use," Geissman said. "We are working with (the FDA) to rectify all their concerns."
For Novartis, the FDA focused on a "Case Highlights" document that described how well Gleevec worked for a particular patient. The FDA said this was misleading because the document implied the drug would work just as well for other patients.
"A selected case study of one patient's treatment response does not constitute substantial evidence," the agency said in the letter.
The FDA's letter to Celgene appears at http://1.usa.gov/w2HyGk, and its letter to Novartis is at http://1.usa.gov/w2HyGk,
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