Regulatory and Washington

ATLANTA — The flu season is in full swing as California reported widespread influenza activity, according to data reported by state and territorial epidemiologists and published by the Centers for Disease Control and Prevention.

NEW YORK — Bloomberg on Friday reported that Express Scripts intends to inform the Federal Trade Commission that the company has delivered all the data requested regarding its purchase of Medco Health Solutions on Friday, which will trigger a 30-day period for a decision from the FTC.

Express Scripts declined to comment for the story, Bloomberg added.

DUBLIN, Calif. — An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.

The FDA's Oncologic Drugs Advisory Committee voted 10-3 with one abstention not to support the risk-benefit profile of Dacogen (decitabine) in certain elderly patients with acute myeloid leukemia. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.

NEW YORK — Controversy over a plan by the Obama administration to require health insurance plans to provide free contraception to women has led the administration to seek a policy that it is calling a compromise with conservative groups opposed to the measure, according to published reports.

The controversy surrounded the new rule's requirement that employee health insurance plans provide free birth control, including those run by the Roman Catholic church, such as hospitals and universities. The Church opposes birth control.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

SILVER SPRING, Md. — The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

NEW YORK — The Center for Reproductive Rights on Wednesday asked a federal court to reopen its 2005 lawsuit against the Food and Drug Administration for imposing age restrictions on emergency contraceptive drugs. Presently, emergency contraceptives, like Plan B One Step, are available behind a pharmacy counter for women 17 years and older but require a prescription for women under the age of 17 years.

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.