Content about Regulatory and Washington

January 3, 2014

Rite Aid is providing prescriptions at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have not received an ID number, the retail pharmacy chain said.

CAMP HILL, Pa. — Rite Aid is providing prescriptions at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have not received an ID number, the retail pharmacy chain said.

The company said that during the month of January, it would dispense a 15- to 30-day supply of many medications to customers who bring in confirmation of their enrollment until their prescription coverage details are available. The Patient Protection and Affordable Care Act, popularly known as Obamacare, took full effect Wednesday.

January 2, 2014

The Centers for Disease Control and Prevention's 2012 Tips From Former Smokers campaign helped more than 100,000 Americans likely quit smoking for good, exceeding the original goal of 50,000, the agency announced Wednesday.

ATLANTA — The Centers for Disease Control and Prevention's 2012 Tips From Former Smokers campaign helped more than 100,000 Americans likely quit smoking for good, exceeding the original goal of 50,000, the agency announced Wednesday. 

The 2013 Tips campaign generated 150,000 additional calls to quitlines and 2.8 million additional website visits.

January 2, 2014

The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies claiming their products can speed recovery from concussions, according to a consumer update posted Wednesday. 

January 2, 2014

The Kroger Co. has joined the list of retailers offering supplies of prescription drugs at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have yet to receive an identification number.

CINCINNATI — The Kroger Co. has joined the list of retailers offering supplies of prescription drugs at no upfront cost to customers who have enrolled in the health insurance marketplaces, but have yet to receive an identification number.

The company announced Thursday that it would offer up to a 30-day supply of certain prescription drugs to customers who provide confirmation of their enrollment at one of the retailer's pharmacies.

January 2, 2014

PureCircle, a producer and marketer of stevia, announced that the Food and Drug Administration has approved PureCircle's Rebaudioside M (Reb M) as a general purpose sweetener for foods and beverages in the United States.

KUALA LUMPUR, Malaysia — PureCircle, a producer and marketer of stevia, announced that the Food and Drug Administration has approved PureCircle's Rebaudioside M (Reb M) as a general purpose sweetener for foods and beverages in the United States. 

January 2, 2014

Patients who have enrolled in the new healthcare insurance marketplaces but haven't received an identification number from their insurers can receive up to a 30-day supply of prescription drugs at no upfront cost at Walgreens, the retail pharmacy chain said.

DEERFIELD, Ill. — Patients who have enrolled in the new healthcare insurance marketplaces but haven't received an identification number from their insurers can receive up to a 30-day supply of prescription drugs at no upfront cost at Walgreens, the retail pharmacy chain said.

January 2, 2014

Walmart is offering prescriptions at no upfront cost to patients who enroll in the public health insurance marketplace, the mass-merchandise retailer said.

BENTONVILLE, Ark. — Walmart is offering prescriptions at no upfront cost to patients who enroll in the public health insurance marketplace, the mass-merchandise retailer said.

December 30, 2013

The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has declined to approve a drug made by Genzyme Corp. for certain forms of multiple sclerosis, the company said Monday.

December 30, 2013

The owners of the compounding pharmacy linked to a nationwide meningitis outbreak that has killed dozens and sickened hundreds have agreed to set up a fund of more than $100 million to compensate victims and creditors.

BOSTON — The owners of the compounding pharmacy linked to a nationwide meningitis outbreak that has killed dozens and sickened hundreds have agreed to set up a fund of more than $100 million to compensate victims and creditors.

Legal firm Brown Rudnick announced that the owners of the New England Compounding Center had reached a settlement with bankruptcy trustee Paul Moore, its creditors and the victims to set up the fund, money from which will be distributed to creditors as well as victims who received injections of tainted steroids from NECC.

December 27, 2013

The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved an HIV pill made by Gilead Sciences for patients who are switching from other therapy regimens, the company said.

Gilead said the FDA approved its single-pill regimen, Complera (emtricitabine; rilpivirine; tenofovir disoproxil fumarate) for use in adult patients who have suppressed their infections on stable antiretroviral regimens and are replacing their current regimens. The FDA originally approved the drug in 2011.

December 27, 2013

The security blogger who broke the news about a massive breach of payment card data at Target stores may have identified someone who's been selling the data.

NEW YORK — The security blogger who broke the news about a massive breach of payment card data at Target stores may have identified someone who's been selling the data.

In his Krebs on Security blog, Brian Krebs identified a Ukrainian man as someone allegedly selling the credit and debit card data, though there was no evidence that the man was behind the theft itself.

December 27, 2013

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

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.

December 26, 2013

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

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.

December 26, 2013

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.

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.

December 26, 2013

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.

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.

December 26, 2013

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.

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.

December 26, 2013

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.

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.

December 23, 2013

A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

BRIDGEWATER, N.J. — A federal court decision paves the way for Amneal Pharmaceuticals and its South Korean partnering company to market a drug for treating gastroesophageal reflux disease, the companies said Monday.

December 23, 2013

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.

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.

December 23, 2013

The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved revisions to the labeling of a leukemia drug made by Ariad Pharmaceuticals that allow the company to resume selling it, the company said.

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

December 23, 2013

The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by United Therapeutics for treating pulmonary arterial hypertension, the company said Monday.

The FDA approved Orenitram (treprostinil) extended-release tablets for treating certain PAH patients to improve exercise capacity. PAH is a disease in which abnormally high blood pressure in the arteries of the lungs causes the right side of the heart to work harder than normal, according to the National Library of Medicine.

December 23, 2013

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. — 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. 

December 19, 2013

While more than half of Americans don't agree with legalizing the sale and possession of small amounts of marijuana for recreational use, most also say that if legal, it should be sold at pharmacies, according to a new survey.

NEW YORK — While more than half of Americans don't agree with legalizing the sale and possession of small amounts of marijuana for recreational use, most also say that if legal, it should be sold at pharmacies, according to a new survey.

December 19, 2013

The National Community Pharmacists Association on Thursday announced the need for legislation in Pennsylvania to protect independent pharmacy operators there.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday announced the need for legislation in Pennsylvania to protect independent pharmacy operators there.