Regulatory and Washington

ALEXANDRIA, Va. — Two lawmakers are calling for a congressional hearing surrounding the role of pharmacy benefit managers in the Medicare Part D prescription drug program.

WASHINGTON — The maker of a breathable caffeine product has received a warning letter from the Food and Drug Administration.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has declined to approve a drug made by Eisai for leukemia in certain elderly patients, the drug maker said.

Eisai said the FDA delivered it a complete response letter for the chemotherapy drug Dacogen (decitabine) in patients ages 65 years and older with acute myeloid leukemia who are not candidates for induction therapy. The FDA delivers a complete response letter when questions remain about an regulatory application that preclude approval, usually due to insufficient clinical trial data.

WASHINGTON — Prices for generic drugs may be dropping, but increases in branded and specialty drug prices have offset those decreases, according to a new study.

The study, conducted by AARP's Public Policy Institute, found that the cumulative change in drug prices from 2005 to 2009 was almost double the rate of inflation. As a result, the average annual cost of drug therapy continued to rise.

WASHINGTON — The Consumer Healthcare Products Association on Tuesday named John Gay as the association's VP government affairs. Gay will begin his duties March 8.

Reporting to CHPA president and CEO Scott Melville, Gay will oversee the association’s state and federal government affairs departments, its political action committee, and will serve as a member of the association’s senior management team.

ARLINGTON, Va. — The Retail Industry Leaders Association, in partnership with Auburn University and with sponsorship from Accenture, on Wednesday released the third annual State of The Retail Supply Chain report.

@RILAtweets will moderate a live Twitter chat March 7 from 12 noon to 1 p.m. EST via #RILAchat to discuss the report findings.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration is asking for additional data before it approves a new cholesterol drug made by Merck, the drug maker said.

Merck said the agency issued a complete response letter for its regulatory approval application for a drug that would combine the cholesterol drug Zetia (ezetimibe) with atorvastatin, the active ingredient in Pfizer's Lipitor. A complete response letter means that the FDA cannot approve a drug application in its current form.

WAYNE, N.J. — The Food and Drug Administration has approved a new formulation of a drug for postmenopausal women.

Bayer HealthCare Pharmaceuticals said the FDA approved a lower-dose formulation of Angeliq (drospirenone and estradiol) tablets, used to treat moderate to severe vasomotor symptoms due to menopause in women who have a uterus. The new formulation contains 0.25-mg drospirenone and 0.5-mg estradiol, while the previously approved formulation contained 0.5-mg drospirenone and 1-mg estradiol.