Oral painkiller approved in line with FDA’s unapproved drugs initiative
ROCKVILLE, Md. The Food and Drug Administration has given the green light to an oral painkiller as part of its unapproved drugs initiative, the agency announced Tuesday.
The FDA approved Roxane Labs’ morphine sulfate oral solution in the 100-mg-per-5 milliliter and 20-mg-per-milliliter strengths for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients.
The FDA granted the approval under a program that began in March 2009 to regulate so-called “grandfathered” drugs – mostly narcotics – that have long been prescribed without approval because they entered the market before the agency adopted its current regulatory policies.
“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton said. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”
Report; N.Y. seeks to prohibit doctors from accepting gifts from drug companies
ALBANY, N.Y. New York Gov. David Paterson hopes to put an end to gifts from drug companies to doctors, according to published reports.
The Associated Press reported Sunday that Paterson proposed legislation that would prohibit drug makers from giving doctors such gifts as pens and free meals to persuade them to prescribe their drugs. Drug companies that violated the ban would be fined between $15,000 and $250,000, while healthcare professionals would be fined $5,000 to $10,000. Nine states so far have laws on the books that prohibit the practice.
According to the AP article, patient-advocacy organizations such as AARP are supporting the legislation, while the Pharmaceutical Research and Manufacturers of America, which represents the branded drug industry, opposes it.
Acorda appoints EVP commercial development
HAWTHORNE, N.Y. The founder of a consulting firm has joined the executive board of Acorda Therapeutics, the drug maker announced Monday.
Lauren Sabella will work as Acorda’s EVP commercial development, reporting to president and CEO Ron Cohen and assuming responsibility for Acorda’s commercial operations such as marketing, sales and managed markets.
Before working for Acorda, Sabella was founder and principal of Tugboat Consulting Group, which assisted companies in commercialization. She also worked as VP commercial development for Altus Pharmaceuticals and served in various positions at Boehringer Ingelheim Pharmaeuticals for 18 years.
“I’m delighted to welcome Lauren Sabella to Acorda’s management team,” Cohen said. “Lauren has an impressive record of achievement in the pharmaceutical industry, including responsibility for launching and managing several high-performing products.”