Regulatory and Washington

WASHINGTON — A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

Big trends can sometimes take centuries or even millennia to develop. Think about how long it took between the dawn of anatomically modern humans and the adoption of agriculture. Health care is no different, having come a long way since the days of bloodletting and the assorted quackeries that were once considered acceptable medical practices.


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.

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 — 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.

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.