FTC seeks public comment on electronic health record security rules
WASHINGTON The Federal Trade Commission has approved a Federal Register notice seeking public comment on a proposed rule that would require notification of patients when the security of their electronic health information is breached, the FTC announced Thursday.
The rule stems from provisions in The American Recovery and Reinvestment Act of 2009 that set aside funding for the adoption of electronic health records but also seek to address security concerns, particularly with regard to health information stored on such Web sites as Google Health, which allows users to store information ranging from prescription information to data collected by electronic devices.
“These innovations have the potential to provide numerous benefits for consumers, which can only be realized if they have confidence that the security and confidentiality of their health information will be maintained,” the FTC said in the statement.
Under the act, the Department of Health and Human Services has until February 2010 to complete a study and report on potential breach notification requirements.
FDA approves hypertension generic
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Abbott’s Oretic, agency records show.
The FDA approved Ipca Labs’ hydrochlorothiazide capsules in the 12.5 mg strength. The drug is used to treat hypertension.
Oretic was originally approved in 1959, and its active pharmaceutical ingredient is used in a number of hypertension drugs.
Biogen Idec receives FDA approval for multiple sclerosis, Crohn’s disease treatment
CAMBRIDGE, Mass. The Food and Drug Administration has given approval to a drug for treating multiple sclerosis and Crohn’s disease.
Biogen Idec announced Thursday that the FDA had approved Tysabri (natalizumab), which already has approval in more than 40 countries as a treatment for moderate to severe Crohn’s disease and relapsing forms of multiple sclerosis. Biogen Idec co-markets the drug with Ireland-based Elan Corp.
Biogen Idec will use a high titer process for which it received approval in the European Union in December to manufacture the drug in higher quantities at its plant in Research Triangle Park, N.C.
“Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing,” Biogen Idec COO Bob Hamm said. “We expect this new process to result in about a four-fold increase in yield.”