Regulatory and Washington

SILVER SPRING, Md. — One month after the observance of Skin Cancer Awareness Month, the Food and Drug Administration announced Tuesday it is taking measures to assure all sunscreen products are safe and effective.

WASHINGTON — There are better ways to reduce expenses for Tricare beneficiaries than to restrict access to community pharmacy. What's more, Congress should adopt alternative cost-saving strategies, including utilizing local pharmacists.

That was a key message in an op-ed co-authored by the National Association of Chain Drug Stores and the National Community Pharmacists Association and published June 13 in The Hill's Congress Blog.

ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.

WASHINGTON — One week after the Senate failed to pass an amendment that would have delayed swipe-fee reform for an additional 12 months, the Department of Justice Antitrust Division reportedly is addressing anticompetitive practices related to credit cards.

The agency has submitted a final consent decree in its enforcement action against Visa and MasterCard, according to the Food Marketing Institute.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

MADISON, Miss. — The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.

Cypress announced the approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) and Rezira (hydrocodone bitartrate and pseudoephedrine). Both drugs are oral solutions and, because they contain the opioid hydrocodone, are classified as schedule III controlled substances by the Drug Enforcement Administration. Cypress subsidiary Hawthorn Pharmaceuticals will market the drugs.

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.