Regulatory and Washington

MONROVIA, Calif. — Regulators in Canada have given a maker of health kiosks the green light to start marketing its products there.

Stayhealthy said Health Canada's Medical Devices Bureau had granted it a license to sell its HealthCenter Kiosk, models 650 and 650-C. The kiosks measure blood pressure, heart rate, total body weight, body-mass index, total body composition and vision and can incorporate data on blood glucose.

DUBLIN — The Food and Drug Administration declined to approve an experimental contraceptive patch developed by Actavis, the drug maker said Tuesday.

Actavis said the FDA sent it a complete response letter for its progestin-only transdermal contraceptive patch. A complete response letter means that the agency has finished reviewing a drug-approval application, but questions remain that preclude final approval.

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years. But according to IMS’ latest figures, it was not the start of a trend.

DEERFIELD, Ill. — The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.

DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck's NuvaRing.

Sales of personal lubricants were down 5.2% to $207.5 million in sales for the 52 weeks ended Oct. 6, according to IRI across total U.S. multi-outlets. A big part of that decrease is due to new Food and Drug Administration regulations that require lubricant manufacturers to submit a 501k medical device application for approval.

ARLINGTON, Va. — A USA TODAY investigation on Friday found that many of those companies marketing dietary supplement containing with drug-spiked products are run by people with criminal backgrounds and regulatory run-ins. 

ARLINGTON, Va. — The Centers for Medicare and Medicaid Services is encouraging health plans to cover patients' existing non-formulary drugs as though they were formulary drugs for the first 30 days after the Jan. 1 rollout of the insurance coverage provided under the Patient Protection and Affordable Care Act.