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News
Ohio Ends Pharmacy Middlemen Contracts Over "Spread Pricing"
Ohio's Department of Medicaid will end the state's contracts with pharmacy benefit managers which bill taxpayers more than they reimburse pharmacists for filling Medicaid patients' prescriptions. Under the new model, PBMs would receive administrative fees and must bill the state the same amount they pay pharmacists.
https://www.cincinnati.com/story/news/2018/08/14/ohio-ends-pharmacy-middlemen-contracts-over-spread-pricing/993354002/
Vaping: The FDA Weighing a Ban on Flavored E-cigarette Liquids
Teen vaping is reaching epidemic levels, and the FDA is considering regulation to curb it. One proposal would be banning flavoring of e-cigarette liquids. Companies "have introduced new products at an alarming pace in total defiance of law, with no apparent concern for FDA enforcement," the groups wrote. More than 2 million middle school, high school, and college teens use these battery-powered devices to heat liquid-based nicotine into an inhalable vapor.
https://www.usatoday.com/story/news/nation/2018/08/13/teen-vaping-fda-weighs-ban-flavored-e-cigarette-liquid/890218002/
Pfizer Also in DOJ Probe of Pharma Bribes Funding Iraqi Terrorists
Pfizer has joined three of its Big Pharma peers in a Department of Justice probe examining allegations that the companies paid bribes to a terrorist-run health ministry in Iraq.
https://www.fiercepharma.com/pharma/pfizer-discloses-department-justice-probe-into-iraq-terrorist-bribery-allegations
India Apotex Plant Receives Third Warning Letter in 4 Years
Apotex, Canada's largest drugmaker, has again had a plant in India cited by the FDA in part because of testing methods that left doubt about the quality of products coming out of the manufacturing facility in Bangalore, India; citing it for many of the same issues uncovered in 2014 and 2015. In fact, the agency pointed out that it has found many of the same issues in a number of Apotex plants over the last five years, displaying its frustration that Apotex seems unable, or unwilling, to learn from past mistakes.
https://www.fiercepharma.com/manufacturing/apotex-plant-india-hit-third-warning-letter-four-years
FDA Compounding Restrictions-Required Medications will Disappear-A Call for Intervention
Abstract
Drug compounding is undergoing a sea of change as the Food and Drug Administration (FDA) is imposing restrictions on what ingredients can be compounded and whether they may be held in the physician's office for multiple uses as well as limiting interstate shipments. The FDA has been subjecting ingredients that have historically been an important part of medical practice to a monograph style review, resulting in rejection of ingredients in favor of approved drugs, even those for which a US Pharmacopeia dietary supplement monograph exists. The article describes the encroachment by the FDA on the practice of medicine and efforts by the American Association of Naturopathic Physicians, the Integrative Medicine Consortium, and the International Academy of Compounding Pharmacists to address problems of access to needed medications.
Conclusion
The FDA's approach to compounding is a case study in a bureaucratic overreaction that threatens to do more harm than the original problem it was intended to solve. The FDA repeatedly cites the NECC tragedy as justification for its wholesale resetting of compounding practice, but there is no nexus between the criminal production of methylprednisolone acetate (MPA) and the removal of scores of needed ingredients from the market or prohibitions from office use. Ironically, pharmacies can still compound preservative-free MPA. Physicians are facing the loss of important drugs and nutraceuticals and the freedom to access them in their office. It is important to be aware of these changes, and to help educate the FDA about the value of these medications.
EVERY COMPOUNDING PHARMACIST SHOULD READ THIS DOCUMENT!!
http://www.imjournal.com/index.cfm/fuseaction/Content.Main/id/101
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