CDER hiring continues apace
WASHINGTON According to new information released by the Food and Drug Administration, the Center for Drugs Evaluation & Research is nearly halfway through hiring its goal of 663 employees, having brought on 309 new employees so far this fiscal year (ending Sept. 30), as reported by RPM.
Some review divisions are benefiting from the hiring frenzy more than others, depending on the previous level of understaffing.
Divisions with the most new hires are the Office of New Drugs with 108, Gastroenterology Products, which has hired 16 employees so far this fiscal year, followed by Cardiovascular & Renal Products (9) and Neurology Products (8). All divisions, with the exception of Anti-Infective and Ophthalmology Products, have hired at least one new employee.
Merck wins liability ruling in N.J. Vioxx case
NEWARK, N.J. According to the New Jersey State Supreme Court, Merck is not liable for the medical monitoring of Vioxx users who are not claiming injury, as reported by the Associated Press. The 5-1 ruling by the state’s highest court means a class-action lawsuit by people who used the once-popular painkiller will be dismissed. One justice did not participate.
Vioxx users who claim they have no immediate symptoms but that use of the drug gives them a greater risk of developing illness filed the lawsuit. So they want diagnostic testing to uncover any hidden or developing problems. But, because they aren’t claiming they have an injury, they aren’t eligible for the settlement Merck announced in November. Merck agreed to pay $4.85 billion to settle thousands of U.S. personal injury lawsuits involving a heart attack, stroke or death. About 45,000 eligible claimants had initiated enrollment as of March 31.
The high court said that since the Vioxx users in the case don’t claim injury, they “cannot satisfy the definition of harm” in seeking medical monitoring under the state’s Product Liability Act. In dissent, Justice Virginia A. Long argued that the law encompassed a broad definition of harm, and includes the concept that an “increased risk of injury that creates a need for medical surveillance” is a recognizable harm.
Merck lawyer Ted Mayer said in a statement that, “The N.J. Supreme Court has made it clear that you cannot bring a medical monitoring claim unless you allege you were injured by a product. The plaintiffs in this suit sought to recover from Merck even though Vioxx has been off the market for almost four years and they do not claim that it ever injured them.”
Merck pulled Vioxx from the market in September 2004 after its own study showed Vioxx doubles risk of heart attack or stroke.
Merck, Health Interactions look to improve conversation on diabetes
CHICAGO and WHITEHOUSE STATION, N.J. Merck and the health education company Health Interactions have announced an expansion of a multiyear relationship to change how healthcare professionals engage patients in learning about diabetes and to improve diabetes self-management education among patients.
Healthy Interactions and Merck now will undertake training and equipping 5,000 additional healthcare professionals with the U.S. Diabetes Conversation Map Program, which allows people with diabetes to communicate in groups that include other diabetics and diabetes educators to help deal and live with the chronic disease. Healthy Interactions developed the program in collaboration with the American Diabetes Association. The enlarged effort also provides for the debut of the U.S. Diabetes Conversation Map Program in Spanish, beginning this month, to help connect with the nearly three million Hispanics and Latinos with diabetes in the United States.
Merck sponsors Training and distribution of the U.S. Diabetes Conversation Map tools. Since launching at the 2007 American Diabetes Association Scientific Sessions, the demand for the U.S. Diabetes Conversation Map Program has been so strong that Healthy Interactions has surpassed its three-year goal of training 10,000 healthcare professionals in just 10 short months.
The expansion of the Conversation Map Program into the Spanish language represents an important milestone. Hispanics and Latinos have a significantly increased risk for diabetes, with Type 2 diabetes occurring at a rate approximately 1.7 times that in the non- Hispanic white population.
“Merck is firmly committed to improving patient education through our flagship program, Journey for Control, and we recognize the value and impact that this Program has for patients with diabetes,” said Kathryn Hayward, U.S. Marketing Leader, Diabetes at Merck.