User login
Ads Misled on Metozolv ODT
Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.
Calif. County Sues Over Avandia
A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.
GSK Ties Underreported
Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.
HbA1c Test Sales Increasing
Hemoglobin A1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA1c assays for automated systems, the report said.
FDA Warns on Food Labels
The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.
Ads Misled on Metozolv ODT
Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.
Calif. County Sues Over Avandia
A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.
GSK Ties Underreported
Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.
HbA1c Test Sales Increasing
Hemoglobin A1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA1c assays for automated systems, the report said.
FDA Warns on Food Labels
The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.
Ads Misled on Metozolv ODT
Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.
Calif. County Sues Over Avandia
A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.
GSK Ties Underreported
Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.
HbA1c Test Sales Increasing
Hemoglobin A1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA1c assays for automated systems, the report said.
FDA Warns on Food Labels
The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.