Content about Regulatory and Washington

MILPITAS, Calif. — LifeScan on Monday initiated a voluntary recall and replacement for all of its OneTouch VerioIQ blood-glucose meters in the United States, effective immediately.

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.

WASHINGTON — Sens. Bob Casey, D-Pa., and Lisa Murkowski, R-Ark., on Friday introduced the Preventing Abuse of Cough Treatments Act of 2013, which would require retailers to restrict the sale of dextromethorphan-containing products to adults. The bill also would restrict the sale of raw, bulk DXM to FDA-approved entities. 

Many retailers have age restrictions on the sale of DXM products already in place; and similar legislation to this has been enforced in California since 2012. 

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated.

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.

PITTSBURGH — The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

Mylan announced the approval of levalbuterol inhalation solution in the 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL strengths. The company has begun shipping the product.

The drug is a generic version of Sunovion's Xopenex inhalation solution, which is used to treat bronchospasm in patients ages 6 years and older with reversible obstructive airway disease.

WASHINGTON — The Campaign for Tobacco-Free Kids is organizing more than 1,200 events across the country to promote smoking abstinence and cessation.

The group announced Friday the 18th annual Kick Butts Day, on March 20, in which young people will encourage peers to stay tobacco-free and educate their communities about the health effects of smoking. While youth smoking rates have gone down, 18.1% of high school students still smoke, the group said.

KANSAS CITY, Mo. — Hostess Brands on Thursday announced that the stalking horse bid submitted by McKee Foods for the Drake's snack cake brand will be presented for approval to the U.S. Bankruptcy Court, as no other qualified bids were received for those assets.

McKee has agreed to pay $27.5 million for the Drake's brand and certain equipment. Drake's products include Ring Dings, Yodels, Devil Dogs, Yankee Doodles, Sunny Doodles and Drake's Coffee Cake.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday endorsed H.R. 1188, legislation introduced by U.S. Reps. Tom Marino, R-Pa., and Judy Chu, D-Calif. The bill will allow independent community pharmacies to collectively negotiate the terms and conditions of insurance contracts they must sign, typically with pharmacy benefit managers that administer prescription drug plans.