Regulatory and Washington


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today. 


ROCKVILLE, Md. — The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced Thursday that it has submitted comments to the U.S. Senate Special Committee on Aging outlining the value of the pharmacist-patient interaction in helping improve health and reduce costs in the Medicare program, and urged the committee to support the Medication Therapy Management Empowerment Act of 2011, which seeks to increase access to pharmacy services for Medicare beneficiaries.

ALEXANDRIA, Va. — Bipartisan legislation recently introduced to the Senate has received endorsement from a group representing the retail pharmacy industry.

HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday announced “grave concerns” regarding a purported Oregon Medicaid plan amendment that would, according to the association, renege on a pact the state previously reached with the Centers for Medicare and Medicaid Services and cut Medicaid pharmacy reimbursement for the second time this year.

ALLEGAN, Mich. — Perrigo on Thursday announced that it has received approval from the Food and Drug Administration to market a cinnamon-flavored, over-the-counter coated nicotine polacrilex gum USP in 2-mg and 4-mg strengths.

The product will be marketed under store-brand labels and is comparable with GlaxoSmithKline's Nicorette Cinnamon Surge coated gum, a stop-smoking aid.

WILMINGTON, Del. — The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.

AstraZeneca announced the approval of Brilinta (ticagrelor), a blood-thinning drug, on Wednesday. The drug maker is touting the drug as an alternative to Plavix (clopidogrel), made by Sanofi and Bristol-Myers Squibb.