Merck’s Isentress approved for children, adolescents
SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.
The FDA announced the approval of Merck’s Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.
"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.
Ranbaxy settles cGMP issues with U.S. government
GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.
The generic drug maker said it had signed a consent decree with the Food and Drug Administration, subject to the approval of the U.S. District Court for the District of Maryland, with the intent to ensure data integrity and comply with current good manufacturing practices. Ranbaxy, which Japanese drug maker Daiichi Sankyo took control of in 2008, also is paying $500 million to the Department of Justice, which was investigating the matter.
"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy’s history," Ranbaxy CEO and managing director Arun Sawhney said. "While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes."
In September 2008, the FDA barred importation of 30 drugs made in Ranbaxy’s plants in Dewas and Paonta Sahib, India, due to cGMP violations found during routine inspections. It was long speculated that the FDA’s actions would jeopardize the drug maker’s planned launch of a generic version of Pfizer’s cholesterol drug Lipitor (atorvastatin calcium), but a resolution of the cGMP problems with the FDA allowed Ranbaxy to launch on Nov. 30, as scheduled.
Walgreens survey: Employers want Walgreens in their pharmacy network
DEERFIELD, Ill. — Walgreens on Wednesday again made its case for keeping its more than 8,000 points of care in the Express Scripts pharmacy network: Excluding Walgreens will not afford Express Scripts’ customers any cost savings. Besides, if Walgreens does wind up out of the Express Scripts network at the top of the new year, many of those health plans and employers will start looking for ways to get Walgreens back in network, most likely by switching pharmacy benefit managers at their first opportunity.
That was the sentiment of the more than 800 anonymous executives and managers who participated in a Walgreens-commissioned survey between Dec. 7 and 14. Walgreens posted those survey results, titled "The Value of Walgreens, Part Two," in time for the chain’s discussion of first-quarter 2012 results with analysts.
"Excluding Walgreens from a pharmacy network will result in little to no savings for most sponsors and patients," Walgreens stated. "Walgreens believes that the vast majority of pharmacies, including Walgreens, receive reimbursements per script that fall within a narrow band, typically within less than 5% of one another. Therefore, excluding any pharmacy with 20% market share from a 5% pricing band can only result in savings on the order of 1% or less."
In the Walgreens proprietary employer survey, 82% of employers said that they would not exclude Walgreens for less than 5% savings on their total pharmacy spend, 60% of employers would not exclude Walgreens for less than 10% savings and 21% would not exclude Walgreens from their network regardless of the amount of savings.
Many self-insured employers won’t have to remove Walgreens from their individual mix. According to the survey, half of all self-insured employers can terminate a pharmacy benefit management contract without cause; 34% with cause. And 51% of employers can contract separately with retail pharmacies that are excluded from their plan’s pharmacy network.
Many of those employers, however, are waiting to see what happens. As many as 45% still expect the issue between Express Scripts and Walgreens to be resolved in the last hour.
A total of 823 executives and managers who self-identified as a final decision-maker or one of the key decision-makers (78% of respondents), or who provide input into pharmacy benefit decisions (22% of respondents), participated in this survey, administered by an independent vendor.
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