Klein to head FDA’s Controlled Substance staff
WASHINGTON Michael Klein has been chosen as the director of the Controlled Substance staff at the Food and Drug Administration.
Klein has been with the Center for Drug Evaluation and Research for 19 years providing leadership on policy and review issues related to drug abuse, addiction drug products and controlled substances, and as team leader and associate director of the CSS.
Prior to joining the agency, he conducted research at Argonne National Laboratory and was a senior scientist with the Drug Enforcement Agency for 15 years.
FDA to increase security for committee members in advisory meetings
WASHINGTON The Food and Drug Administration is planning on beefing up its security at advisory committee meetings, in hopes of restoring order after an incident at a recent meeting, according to The Regulation Policy Market Report.
According to reports, an intoxicated speaker in the audience at a recent meeting began a threatening rant. This isn’t the first time there have been disturbances at an advisory committee, they usually occur when the drug in question is used to treat rare-or life-threatening disease.
While the FDA hasn’t made a formal announcement of the policy changes, Office of New Drug director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.
“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”
Those procedures include:
1) Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.”
2) Increasing the presence of security guards in the committee room—both in uniform and street clothes.
3) Reading a statement at the start of the meeting about “good rules of behavior.”
FDA approves Eisai’s Aciphex for ages 12 and up
WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved Aciphex for treatment of gastroesophageal reflux disease in adolescents age 12 and older, Tokyo-based Eisai’s North America subsidiary announced Monday.
Aciphex, known generically as rabeprazole sodium, is available in 20 mg tablets for treating GERD for up to eight weeks.
Eisai discovered and developed the drug and promotes it in the United States with PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals.