Regulatory and Washington

BALTIMORE — The Centers for Medicare and Medicaid Services earlier this month released a memo to all Part D sponsors, warning them that the agency has "observed an increase in beneficiary complaints related to the transfer of prescriptions from retail pharmacies to either mail-order or specialty pharmacy without their explicit consent."

ATLANTA — Asthma is having a growing effect on the country's health, according to a new study.

The Centers for Disease Control and Prevention released its "Asthma's Impact on the Nation" report Wednesday, based on data gathered using the "Asthma Call-back Survey" of people with the disease. An estimated 29.1 million American adults, or 12.7% of the total, have been diagnosed with asthma in their lifetimes, while 18.7 million, or 8.2%, still had asthma in 2010.

DUBLIN, Ohio — Cardinal Health on Tuesday announced it had agreed to a settlement with the Drug Enforcement Agency that allows the company to bring resolution to ongoing litigation.

NEW YORK — Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

The Pittsburgh Post-Gazette reported that the bills, sponsored by Republican Rep. Tim Murphy of Pennsylvania, would create an expedited FDA approval pathway for follow-on versions of biogenetic medications such as vaccines and drugs made from human tissue and plasma.

WASHINGTON — The Center for Medicare and Medicaid Services needs to beef up its oversight on Medicare Part D submissions from retail pharmacy, according to an Office of Inspector General report published last week.

The OIG suggested CMS strengthen a MEDIC's ability to track pharmacy billing (MEDICs — Medicare Drug Integrity Contractors — are private organizations who are contracted by CMS to assist in anti-fraud and abuse efforts) and improve compliance plan audits, specifically targeting independent pharmacies and pharmacies in urban locales.

FOSTER CITY, Calif. — Gilead Sciences scored a second favorable Food and Drug Administration expert panel vote as the FDA's Antiviral Drugs Advisory Committee recommended on Friday that the regulatory agency approve an experimental drug designed to treat HIV.

WASHINGTON  — Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

The FDA ordered the changes last summer but gave manufacturers one year — until this June — to get the revised bottles on the shelf.

NEW YORK — Budget cuts have added an extra challenge to the response of health authorities in Washington state to an epidemic of whooping cough, according to published reports.

According to a report by the Washington State Department of Health, there were 1,284 cases of whooping cough, also known as pertussis, reported so far for 2012, compared with 128 during the same period last year. No deaths have been reported so far.