Regulatory and Washington

NEW YORK — The Food and Drug Administration is reviewing emergency contraceptives like Plan B One-Step on whether they are less effective in women weighing more than 165 lbs., according to a report published Monday by Reuters. 

FLINT, Mich. — Four pharmacists from Diplomat are among the 49 across the country who have received certification from the Specialty Pharmacy Certification Board, Diplomat said Monday.

Diplomat said VP clinical services Gary Rice, clinical technology manager Michael Crowe, pharmacy manager Nicole Hubach and clinical manager Ryan Nolan had received the SPCB's Certified Specialty Pharmacist endorsement. The SPCB announced on Nov. 11 the first 49 pharmacists to become CSPs. The tests for the credential were administered in October.

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new treatment made by Johnson & Johnson for hepatitis C, the drug maker said.

SPRINGFIELD, Va. — Executives from retail, manufacturing, regulation and others are among the four new appointees to the Pharmacy Quality Alliance's board of directors for next year, the group said Monday.

SILVER SPRINGS, Md. – Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

NEW YORK — The Food and Drug Administration has granted regular approval to a new drug made by Pfizer for treating a form of lung cancer, the drug maker said.

SILVER SPRING, Md. – The Food and Drug Administration has approved a drug made by Bayer HealthCare Pharmaceuticals for treating thyroid cancer, the agency said Friday.

The FDA announced the approval of Nexavar (sorafenib) to treat late-stage differentiated thyroid cancer. The drug was already approved for kidney and liver cancers. The drug works by limiting cancer cell growth and replication by inhibiting proteins within the cells.

Pharmacists traditionally have been one of the most underutilized members of the healthcare team, possibly because they hadn’t been officially recognized as part of that team. That, however, is about to change.