Regulatory and Washington

WHITEHOUSE STATION, N.J. — The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

Merck said the FDA would seek to complete its review of the application for the drug boceprevir within six months. Authorities in the European Union have granted expedited review as well.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

The FDA approved Actemra (tocilizumab) for the inhibition and slowing of structural joint damage, improvement of physical function and achievement of clinical response in patients with moderate to severe rheumatoid arthritis. The drug originally was approved as a treatment for RA last year.

SILVER SPRING, Md. — Certain tobacco products introduced to the market or changed after Feb. 15, 2007, are subject to enhanced scrutiny by the Food and Drug Administration, the agency said Wednesday.

EDINA, Minn. — Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.

ALEXANDRIA, Va. — Congress handed community pharmacies a Christmas present in December, voting to exempt them from burdensome accounting requirements imposed by the Federal Trade Commission.


NEW YORK — In a slew of interviews in recent months with ABC News, Fox News, CNN and even the BBC, Donald Trump has made no secret of the fact that he’s seriously considering a presidential bid in 2012.


In an interview with ABC News correspondent George Stephanopoulos, Trump described himself as a Republican, and said that if he decided to run, it would be as a Republican. He added, “I’m going to make a decision probably by June.”

CLINTON, N.J. — The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

ALEXANDRIA, Va. — It’s a battle that raged for more than three years. But in mid-December, the retail pharmacy industry was able to declare a clear, unequivocal victory.


We’re talking, of course, about the struggle to head off what would have been a devastating change in the way Medicaid pays community pharmacies to dispense generic drugs to low-income patients. On Dec. 14, the chain and independent pharmacy lobbies announced they had reached a landmark agreement with the 
Centers for Medicare and Medicaid Services that effectively ends the threat.