Licensing

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

WASHINGTON — The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

NEW YORK — Bills introduced in Oregon's state legislature would allow employers and other health plan sponsors to have greater knowledge about how pharmacy benefit managers determine the rates at which they pay pharmacies for dispensing generic drugs; establish new standards for pharmacy audits while requiring PBMs to register in the state and be licensed by the state board of pharmacy; and prevent health plans from requiring residents of the state to use mail-order pharmacies.

WASHINGTON — The Pharmacy Technician Certification Board is making changes to its certification program that it said would advance pharmacy tech certifications, the group announced.

The PTCB said that over the next seven years, it would phase in the changes, which include mandatory background checks, accredited education requirements and changes in acceptable continuing education programs for recertification. The group said its requirements have remained largely unchanged since its 1995 founding.

WOODCLIFF LAKE, N.J. — Valeant Pharmaceuticals has bought rights to a drug used to treat skin cancer from Eisai, the companies said Thursday.

Valeant has bought the rights to Targretin (bexarotene) capsules and gel from Eisai for $65 million upfront, plus additional payments based on certain milestones. Under the deal, Eisai has transferred its regulatory approval application to Valeant, which will assume responsibilities for all regulatory obligations associated with the product in the United States. Eisai will retain rights to the drug outside the United States.

OKLAHOMA CITY — Legislation that would require pharmacy benefit managers to seek licensure from the Oklahoma State Board of Pharmacy if they were to distribute medicines to Oklahoma residents was introduced on Tuesday, according to an Associated Press report. 

NEW YORK — A new bill in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports.

The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years.