Pharmacy Briefing is a monthly summary of select U.S. Food and Drug Administration (FDA) approvals and launches, treatment guidelines and research updates, and other newsworthy events that have the potential to impact commercial drug utilization or costs.
- FDA grants Emergency Use Authorization for Pfizer/BioNTech COVID-19 vaccine
- Amazon enters retail pharmacy sector, launches Amazon Pharmacy
- United Kingdom approves Pfizer/BioNTech COVID-19 vaccine
- Kaiser Family Foundation report describes COVID-19’s effect on national health spending and utilization
FDA Approvals and Launches
- Sesquient (fosphenytoin injection) is approved to treat status epilepticus.
- Flu treatment Xofluza (baloxavir marboxil) receives additional indication for use in flu prevention (post-exposure prophylaxis).
- Oxlumo (lumasiran) is approved to treat primary hyperoxaluria type 1, a rare genetic disorder.
- Orladeyo (berotralstat) is approved to treat hereditary angioedema.
FDA grants Emergency Use Authorization for Pfizer/BioNTech COVID-19 vaccine
- The decision follows a recommendation from the agency’s Vaccines and Related Biological Products Advisory Committee.
Amazon enters retail pharmacy sector, launches Amazon Pharmacy
- The online pharmacy can service patients with or without insurance and provides free two-day delivery for Prime members.
- The service currently comes with some limitations.
- No option of 90-day fills or automatic refills.
- Examples of unavailable products include diabetic testing supplies, schedule II-controlled substances, specialty medications, and liquid suspensions.
Kaiser Family Foundation report describes COVID-19’s effect on national health spending and utilization
- As of the third quarter (Q3) 2020, authors found a decrease of 2.4% in non-pharmaceutical health spending relative to the same period in 2019.
- As of October 2020, pharmaceutical spending increased 6.3%.
HHS and FDA under legal pressure against drug importation final rule
- The Pharmaceutical Research and Manufacturers of America (PhRMA), Partnership for Safe Medicines, and Council for Affordable Health Coverage describe public health and safety risks and other concerns in their complaint.
FDA advisory committee rejects endorsement of investigational Alzheimer’s drug aducanumab
- The drug, if approved, would be the first Alzheimer’s treatment approved in over 17 years.
U.S. Department of Health and Human Services (HHS) Special Fraud Alert warns against prescription kickback loophole
- The alert highlights the practice of drug manufacturers awarding high-prescribing healthcare providers with speaking deals worth potentially hundreds of thousands of dollars.
- HHS cautions that this practice violates federal anti-kickback statutes.
OptumRx publishes Q4 Drug Pipeline Insights Report
- The report highlights five drugs with FDA decisions in the near future, including novel cholesterol drug inclisiran.
United Healthcare delays implementation of Accumulator Adjustment – Medical Benefit program
- The program faced public backlash from several groups including the American Academy of Family Physicians and American Medical Association.
Clinical Trials and Research
Pfizer/BioNTech and Moderna produce positive COVID-19 vaccine trial results
- As a result of the clinical trial data, the manufacturers of the two vaccines have submitted requests for Emergency Use Authorization to the FDA.
- The vaccines require two separate doses to achieve full efficacy.
United Kingdom becomes first country to approve a COVID-19 vaccine
- The country approved the vaccine developed by manufacturers Pfizer and BioNTech.
- As of December 9, Bahrain and Canada have also approved the same product.
Investigational long-acting HIV drug, cabotegravir, achieves endpoints in superiority trial
- The injectable drug is dosed once every two months and was found to be more effective than daily Truvada (emtricitabine/tenofovir disoproxil fumarate) at preventing HIV transmission in women.