Regulatory and Washington

BONITA SPRINGS, Fla. — Two weeks before the Food and Drug Administration met on expanding the switch paradigm, attendees of the Consumer Healthcare Products Association’s Annual Executive Conference discussed how over-the-counter medicines can help shape health care as part of a panel featuring Joe Magnacca, Walgreens president of daily living products and solutions.

DEERFIELD, Ill. — The Food and Drug Administration is requesting additional data from two drug makers for a treatment for immune system disorders.

Baxter and Halozyme said the FDA wanted more data to review their application for HyQ, a combination of immune globulin and recombinant human hyaluronidase.

The companies said they would work to develop studies to provide additional data to address the agency's concerns.

ATLANTA — Children under the age of 10 years old may be especially susceptible to a new strain of influenza, according to an article published Friday in the Center for Disease Control and Prevention's "Morbidity and Mortality Weekly Report."

BOSTON — The Pharmaceutical Research and Manufacturers of America announced Friday the appointment of Eli Lilly chairman, president and CEO John Lechleiter as PhRMA chairman at its annual meeting. The group also elected Celgene president and CEO Robert Hugin as chairman-elect of its board of directors and Pfizer president and CEO Ian Read as board treasurer. Lechleiter replaces Sanofi CEO Christopher Viehbacher as chairman.

WASHINGTON — Drug companies invested nearly $50 billion in research and development in 2011, according to a new report by a drug industry trade group.

Health is what you make of it. And judging from a recent public meeting held by the Food and Drug Administration, health is about to be made a lot less expensive as the agency explores ways to expand which therapy categories can be made self-selection- and self-care-friendly through communication or diagnostic technology in conjunction with a consultation with a retail healthcare professional. 


PITTSBURGH — The Food and Drug Administration has approved a generic drug for lipid disorders made by Mylan, the company said Friday.

Mylan announced the approval and launch of fluvastatin capsules in the 20-mg and 40-mg strengths, a generic version of Novartis' Lescol. The drug is used to treat hypercholesterolemia and mixed dyslipidemia, as well as prevention of cardiovascular disease.

The drug had sales of $27.9 million in 2011, according to IMS Health.

Get set for another decade of explosive growth throughout the over-the-counter category with the familiar switch as a catalyst. 


The Food and Drug Administration public meeting that took place last month addressed a proposal to expand the switch paradigm by utilizing the latest in communications and diagnostics technology and/or incorporating the most accessible healthcare professional — the retail pharmacist — into the self-care decision protocol.