Regulatory and Washington

SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.

WASHINGTON — A new study indicates that the public bears "unnecessary expense" when generic drugs aren't used.

NORTH BERGEN, N.J. — The Vitamin Shoppe's proposed acquisition of Super Supplements has been delayed, the company recently announced. According to the company, the Federal Trade Commission had notified VSI that it is conducting an investigation into the planned acquisition, noting that the investigation will extend beyond Dec. 31, 2012.

SAN FRANCISCO — Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.

The 2013 California Biomedical Industry Report — by PwC, the California Healthcare Institute and BayBio — looked at California's biotech industry and how it faired in 2012.

NEW YORK — An organization focused on inflammatory bowel disease has enlisted a star of "NYPD Blue," "Judging Amy" and "Private Practice" to raise awareness of the condition.

The Crohn's and Colitis Foundation of America hired actress Amy Brenneman, who has ulcerative colitis, one of two diseases that collectively make up IBD; the other is Crohn's disease. Both conditions are autoimmune diseases that cause discomfort and inflammation of the intestines and require frequent trips to the bathroom.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

NEW YORK — The Electronic Retailing Self-Regulation Program on Tuesday recommended that Casper Labs modify or discontinue certain claims for Calmestra, a dietary supplement marketed as providing relief for symptoms of menopause, including claims that the product has been “clinically proven” to address symptoms of menopause.

WESTON, Mass. — Biogen Idec is seeking Food and Drug Administration approval for a hemophilia drug that it called the first of its kind.

The drug maker announced that it had submitted a regulatory application for recombinant factor IX Fc fusion protein, or rFIXFc, which it called the first long-lasting factor IX therapy for hemophilia B.