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This week, we will continue looking at the current Draft Memorandum of Understanding recently issued by the FDA for public comment.
The sections of the Draft Memorandum generally include the following:
- Purpose (Discussed in the September 21, 2018 Newsletter)
- Background (Discussed in the September 21, 2018 Newsletter)
- Conditions to be satisfied for exemption
- Qualifying for these exemptions
- Substance of Agreement
- Investigation of Complaints Relating to Compounded Drug Products Distributed Outside the State
- Distribution of Inordinate Amounts of Compounded Drug Products Interstate
- Submission and Disclosure of Information
- Enforcement Authorities and Legal Status of Agreement
- Name and Address of Participating Agencies
Section III Substance of Agreement is quite detailed and will be discussed over the next three weeks in this Newsletter.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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News
Reducing Drug Costs—PBMs are Not Needed and Should Not be Used!
Drug costs handled via PBMs continue to increase and PBMs have become even more self-serving! PBMs, pharmaceutical companies, and health-insurance companies accuse each other as being primarily responsible for the increasing costs.
Editor's Note: Obtain a free copy of the latest edition of The Pharmacist Activist and read about PBMs, Patient Experiences, PBM Practices/Abuses, Consequences, and Recommendations. The Pharmacist Activist is a free publication that can be accessed at:
www.pharmacistactivist.com
New Testosterone Drug Gets FDA Approval
Nearly a year after being rejected, Antares Pharma Inc.'s injectable drug to treat low testosterone levels in men has been approved by the FDA, as announced by Antares. The drug, however, comes with a boxed warning—the FDA's strongest—flagging risks of a rise in blood pressure that can cause major cardiovascular events. The FDA had declined to approve the drug, Xyosted, in October of 2017, highlighting elevated blood pressure, depression, and suicidal tendencies in patients. Prescriptions for low testosterone, or "Low T," have soared over the past decade, driven by a surge in use by aging men. About 6.5 million retail prescriptions for testosterone replacement therapy were filled in 2017, the company said.
AbbVie Inc.'s AndroGel, one of the most widely used products with sales of $577 million in 2017, accounts for roughly 60% of the total testosterone replacement therapy market.
Xyosted, which is indicated for testosterone replacement therapy in adult males with a deficiency or absence of endogenous testosterone, has been approved in three dosage strengths; 50 mg, 75 mg, and 100 mg.
https://www.reuters.com/article/us-antares-pharma-fda/antares-pharmas-testosterone-drug-gets-fda-approval-idUSKCN1MB2BM
Epidiolex Placed in Schedule V of the Controlled Substance Act
The DEA announced that Epidiolex, the newly approved medication by the FDA, is being placed in schedule V of the Controlled Substances Act (CSA), the least restrictive schedule of the CSA. In June 2018, the FDA announced it approved Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. Epidiolex contains cannabidiol (CBD), a chemical constituent of the cannabis plant. The CBD in Epidiolex is extracted from the cannabis plant and is the first FDA-approved drug to contain a purified extract from the plant.
https://www.dea.gov/press-releases/2018/09/27/fda-approved-drug-epidiolex-placed-schedule-v-controlled-substance-act
Drug Shortages
Note: At the official FDA website, there are 108 listed items.
https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm?utm_campaign=09-28-2018%20Drug%20Shortages
Note: At the ASHP website, there are 193 listed items.
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortages-List?page=CurrentShortages
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