|
Two Classes of Compounding in the Future?
FDA commissioner Margaret Hamburg is proposing two classes of compounders in the future: traditional and nontraditional. In her prepared remarks this week before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, Hamburg discussed traditional and non-traditional compounding. Traditional compounding refers to the recognized practice of mixing or altering ingredients for individual patients on an as-needed basis. However, non-traditional compounding poses a higher risk that she argues would—and should—require federal government oversight.
Hamburg also proposes that compounding pharmacies be required to register with the agency to presumably make it easier to coordinate efforts with state regulators when necessary. In addition, she suggests that compounders report adverse events and start labeling their products.
http://www.pharmalot.com/2012/11/fda-wants-two-classes-of-compounding/
http://www.washingtonpost.com/national/health-science/house-panel-grills-fda-about-compounding-pharmacies/2012/11/14/f9f7a7e8-2e9d-11e2-89d4-040c9330702a_story.html
Note: The written Statement of Margaret A. Hamburg, M.D., proposed that "non-traditional compounding" might include some statutorily-specified combination of: the type of product/activity (e.g., sterile compounding); the amount of product being made; whether the production is being done before the receipt of a prescription or order for a particular patient (so-called "anticipatory compounding"); whether the compounded drug is being shipped interstate; or whether the drug is being dispensed to someone other than the ultimate user when it leaves the facility where it was produced.
CVS' PBM Plans to Stop Coverage of Certain Drugs
CVS Caremark pharmacy-benefit business is targeting certain treatments for low testosterone and glaucoma, among other conditions, in its latest push to promote available alternatives to what it says are expensive drugs. It plans to block coverage for 17 more drugs starting January 1, 2013, including Abbott's testosterone treatment Androgel and Pfizer's overactive-bladder drug Detrol LA.
This move adds to its list of more than 30 drugs blocked for 2012—while also reinstating a few—in what industry consultants say was a particularly aggressive effort to secure pricing deals from drug makers. They will cover equally effective products with lower overall costs including many generics that remain available on the formulary.
| 
