May 5, 2024: New UTI treatment; FDA regulation of gene-editing in animals; drug shortages; self-medicating orangutan; more
New Drug Approvals
The U.S. Food & Drug Administration (FDA) approved antibiotic Pivya (pivmacilliman) to treat uncomplicated urinary tract infections (UTIs) in women. While the treatment is new in the U.S., the tablet has been used in Denmark since the 1970s. The approval was granted to U.K. biotechnology company Utility Therapeutics.
https://www.singlecare.com/blog/news/pivya-fda-approval/
The FDA approved Altor Immunity Bioscience’s immunotherapy drug Anktiva to treat advanced non-muscle bladder cancer.
https://www.fiercepharma.com/pharma/soon-shiongs-immunitybio-bags-fda-approval-anktiva-challenge-merck-bladder-cancer
Pediatric Approvals
The FDA approved Aquestive Therapeutic's medication Libervant (diazepam) for the treatment of seizure clusters in children age 2 to 5 with epilepsy. This medicine is easier to administer in young children because it is administered bucally - inside the cheek.
https://www.pharmexec.com/view/fda-approves-aquestive-therapeutics-libervant-for-the-treatment-of-seizure-clusters-in-children-aged-2-to-5-years
Abbvie's eczema drug Rinvoq was approved for children (age 2 and up) with active polyarticular juvenile idiopathic arthritis (JIA) or psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. JIA is the most common type of arthritis in kids and teens. Previously, it had only been approved for age 12 and up.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211675
The FDA approved Xolremdi (mavorixafor) capsules in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-drug-whim-syndrome-rare-disorder-can-lead-recurrent-life-threatening-infections
Regulatory News
The rules for pharmaceutical television commercials are slated to change this month, with requirements for more disclosure about side effects without distracting video that often muddles the risk message. MedShadow Foundation’s Melissa Finney explains and provides commentary on the new rules.
https://medshadow.org/sick-of-ads-for-meds-the-rules-are-about-to-change/
Under a new order issued by the Federal Trade Commission (FTC), telehealth company Cerebral must limit the consumer health data it uses for advertising purposes. Cerebral provides mental health services, including counseling and prescriptions for conditions like anxiety and depression. The company also agreed to pay $7 million to resolve charges that it disclosed customers’ personal health information to third parties for ads, and that it did not honor its promise to make cancellation easy for customers.
https://themarkup.org/pixel-hunt/2024/04/22/cerebral-to-pay-7-million-fine-and-limit-health-data-use-for-ads-under-federal-order
Gene Editing Oversight of Animals: FDA or USDA?
The FDA issued two guidance documents that attempt to clarify how it intends to regulate genetic modifications made to animals using CRISPR and other technologies. These intentional changes to an animal's DNA are referred to as IGAs.
In the first guidance document, the FDA explains that it will use a risk-based approach to overseeing IGAs in animals. IGAs will be categorized based on their risk level, from low-risk (Category 1) to higher-risk (Category 3)
Developers of low-risk Category 1 products will not be expected to consult with the FDA prior to marketing an animal, since risk is well-known and mitigated.
For Category 2 products, the FDA may not expect an application for approval of the IGA if, after looking at data submitted about that product's risk, the FDA understands the product's risks for the specified intended use, any identified risks are appropriately mitigated, and the FDA has no further questions for which it would need to see additional data to address.
In the case of Category 3 products, the FDA will review and, where the data supports it, “approve a product using data requirements that are proportionate to the risk associated with the particular product.”
In the second guidance document, the FDA announces that it completed a memorandum of understanding (MOU) with the United States Department of Agriculture (USDA) to clarify the roles and responsibilities of the FDA and USDA in regulating IGAs in animals. The USDA typically regulates livestock animals used for food, such as beef cattle, pork, and poultry, while FDA regulates other animals used for food along with animals used for drug testing and veterinary drugs.
Curious approvals have resulted from the division of responsibilities within the FDA and between the FDA and USDA. For example, in 2015, the FDA approved AquaBounty’s genetically engineered Atlantic salmon, followed by a supplemental FDA application in 2018 that allowed it to be farmed in land-locked tanks in Indiana and other places far from the ocean. The approved genetic engineering technology involves inserting a growth hormone gene from Chinook salmon into the Atlantic salmon, causing it to grow three times as fast as regular salmon. But the FDA approved the technology as if it were a veterinary drug – even though the genetically engineered salmon was to be farmed as food for humans.
The MOU indicates that the FDA will continue to take the lead in regulating intentional genomic alterations in animals, with assistance from the Agriculture Department on specific products. “To me that’s a step in the right direction, but it’s not to the right endpoint yet,” said Jon Oatley, an associate dean in the college of Veterinary Medicine at Washington State University, and developer of CRISPR technology for use in livestock. Oatley favors more USDA involvement in biotech regulations.
https://www.agri-pulse.com/articles/21045-document-solidifies-fda-authority-over-genomically-altered-animals-with-new-input-from-usda
Drug Shortages
Drug shortages reached a record high in the first three months of 2024, with 323 drugs in low supply. The previous record was set in 2014 with 320 drugs in shortage, according to data provided by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service. Both basic and life-saving drugs are in short supply, from oxytocin and chemotherapy medications to prescriptions for to attention deficit hyperactivity disorder (ADHD) medications.
https://www.usatoday.com/story/news/nation/2024/04/17/drug-shortages-2024-record-high/73361588007/
Opioid pain drugs have been in short supply since summer 2023. The U.S. Drug Enforcement Agency (DEA) dictates the quantity of controlled substances that drug companies are allowed to make, and had recently set annual instead of quarterly quotas for many Schedule II drugs (like morphine and injectable opioids) shortages. In response to the unanticipated problems the new quota schedules caused, the DEA has reverted back to annual procurement quotas for morphine drugs.
https://kffhealthnews.org/morning-breakout/morphine-regulation-is-changed-back-after-plan-to-avert-shortages-backfired/
Orangutan Self-Medicates with Medicinal Plant
An orangutan in Sumatra surprised scientists when he was seen treating an open wound on his cheek with a medicinal plant. Three days after an injury, he carefully picked leaves off a liana plant, chewed on them, and then applied the resulting salve and leaf mixture onto his facial wound. It’s the first scientific record of a wild animal healing a wound using a plant with known medicinal properties. The findings were published in Nature Scientific Reports
https://www.nature.com/articles/s41598-024-58988-7
Medication and Supplement Tips
Are you taking a collagen supplement? Are you taking too much? This article from “The Checkup” gives practical advice about collagen supplements.
https://www.singlecare.com/blog/how-much-collagen-per-day/
Did you know that National Prescription Drug Takeback Day was last Saturday, April 27? If you missed it, no worries. Read here about three options for disposing of your unused or expired medications, including donating those that are unopened and unexpired so that they can be used by another patient.
https://askapatientnews.substack.com/p/eco-friendly-medication-disposal-donations
Looking for recent FDA drug labeling changes? There are two significant ones so far this month, for plaque psoriasis drug Otezla and also for oxycodone pain drugs.
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