Regulatory and Washington

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.

ATLANTA — An early look at this season’s reports indicates that about 90% of flu-related pediatric deaths occurred in children who had not received a flu vaccination this season, the Centers for Disease Control and Prevention reported Friday. 

The number of influenza-associated pediatric deaths reported to the CDC during the current season surpassed 100 as an additional 6 deaths were reported in FluView last week. To date, this brings the total number of influenza-associated pediatric deaths reported to the CDC to 105 for the 2012-2013 season.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

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. 

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

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.

ATLANTA — Norovirus has emerged as the leading cause of gastroenteritis — inflammation of the stomach and intestines — in children younger than 5 years, according to a new study.

BRATTLEBORO, Vt. — New Chapter on Wednesday voluntarily recalled a limited number of packages of its 90-count Probiotic Elderberry dietary supplement because it may contain an undeclared allergen - soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product, the company stated.  

The one lot of affected New Chapter Probiotic Elderberry was distributed nationwide. It reached consumers through retail stores, mail order and direct delivery.