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.

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.

WHITESTONE, N.Y. — Business mogul, real-estate developer on a colossal scale with an ego to match, reality TV star, highest of the high-profile billionaires. Could Donald Trump’s next big role be president of the United States?


More importantly, would Trump the president be good for the country and, more specifically, for retail and wholesale pharmacy?


SILVER SPRING, Md. — Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

The Washington Post reported Wednesday that Sharfstein, the FDA’s top official after commissioner Margaret Hamburg, had received an invitation to head the state health department from Gov. Martin O’Malley.

Before assuming his position at the FDA, Sharfstein served as head of the Baltimore City Health Department.



Last month, the American Journal of Managed Care published a review of more than 40 years worth of studies from various medical journals that demonstrated that the best way to improve adherence is to get patients to talk to the store pharmacist; the second-best way is to get them to talk to a nurse before they leave the hospital.


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.