Following the 2012 scandal involving 64 patients who died and another 750 who became ill with fungal meningitis traced to unsterile conditions in a New England compounding pharmacy, the US Food and Drug Administration has been given new powers to enforce safety issues related to that practice.But at the American Medical Association’s annual House of Delegates (HOD) meeting in Chicago June 7, physicians from several medical specialties urged the AMA to lobby for regulations safe-guarding their own right to compound drugs in their offices.Those who spoke included dermatologists, ophthalmologists, infectious disease doctors, and oncologists.
In ophthalmology, delegates pointed out, doctors are able to save patients a lot of money. In treating a form of macular degenerations, they can repackage the cancer drug bevacizumab (Avastin/Genentech) off-label at a cost of about $40 a dose. It would cost more than $1,000 when given as a prepackaged eye drug.
In dermatology, compounding enables doctors to devise psoriasis treatments that are tailored to individual patients’ needs, or to add saline solution to botulinum when using the toxin to treat muscle spasms.
In a resolution under consideration, the AMA will vote on whether the Drug Quality and Security Act of 2013 giving the FDA new powers to regulate drug compounding practices “has led to burdensome regulatory restriction on simple preparation of FDA-approved medications for office-based procedures.”
The resolution asks the AMA to monitor the FDA’s enforcement of the new law and “encourage the development of regulations that ensure safe compounding practices that meet patient and physician needs,” without restricting in-office compounding meant for individual patients immediate use.
At the same time, the resolution affirms the AMA’s commitment to seeing that unsafe and unscrupulous compounding pharmacy operations are subject to a high level of regulation and scrutiny.
In the absence of new federal legislation affecting the oversight of compounding pharmacies, the resolution calls on the AMA “to encourage state boards of pharmacy and the National Association of Boards of Pharmacy to work with the United States Food and Drug Administration to identify and take appropriate enforcement action against entities that are illegally manufacturing medications under the guise of pharmacy compounding.”
But “allowances must be made for the conduct of compounding practices that can realistically supply compounded products to meet anticipated clinical needs, including urgent and emergency care scenarios,” the resolution notes.