Government plans supply chain pilot program for added control over Rx
ROCKVILLE, Md. The government might soon implement a secure supply chain program to prevent the importation of drugs that don’t meet regulatory requirements.
The Food and Drug Administration announced Wednesday the launch of a voluntary trial run to determine the practicality of the program. The agency plans to select 100 companies to participate, requiring them to maintain control over up to five drugs they enter into the program from the time of manufacture to their entry into the United States. The FDA developed the program with help from U.S. Customs and Border Protection.
The program would prevent non-compliant drugs from entering the country while expediting the entry of those that do comply with FDA requirements.
“This initiative creates incentives for drug makers to develop and maintain secure supply chains,” said Deborah Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research. “This is one of several agency initiatives to enhance drug product safety.”
Assurant Health announces benefits partnership with Take Care
MILWAUKEE Assurant Health has announced that its health plan members can now receive in-network benefits at all Take Care Clinics.
With the addition of the 322 Take Care Clinics, which are located within Walgreens stores, Assurant Health customers with Individual Medical, Short Term Medical and Real Choices Small Group plans have access to more than 800 retail health clinics throughout the United States.
“This agreement is part of our continuing commitment to give our customers more choices and convenient access to affordable health care options,” said Scott Krienke, SVP of product lines for Assurant Health.
Added Peter Miller, president and CEO of Take Care Health Systems, “Our goal is to provide access to care to as many individuals as possible. Partnering with companies like Assurant Health allows us to offer our model of care to more individuals across the country, and this national contract sets the stage for continued coverage as we expand our model to new markets and states.”
FDA approves generic version of Medicis’ Loprox
ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of Medicis’ Loprox, FDA records show.
The agency approved Paddock’s ciclopirox gel in the 0.77 percent strength on Jan. 7. The gel is used to treat seborrheic dermatitis.
Medicis’ non-acne skin medicines had sales of $173 million in 2007, according to Medicis financial data, which did not list separate figures for Loprox. Nycomed also makes a generic version of the 0.77 formulation, while Medicis continues to market the 1 percent formulation.