This Week at FDA: Amazon warning letter, ANDA amendments, and more

This Week at FDAThis Week at FDA
| 12 August 2022 | By Michael Mezher 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we take a look at warning letters sent to online retail giant Amazon and two other companies for selling unapproved drugs for mole and skin tag removal. Plus, FDA has opened a public docket to gather feedback on its abbreviated new drug application (ANDA) amendments guidance, and we learned that Bavarian Nordic has some “reservations” about the Biden administration’s dose-sparing plan to stretch out the available doses of its monkeypox vaccine Jynneos.
Earlier this week, FDA sent warning letters to three companies, including online retail giant Amazon, for selling unapproved drugs for mole and skin tag removal. The other companies cited include Ariella Naturals and Justified Laboratories. In its warning letter to Amazon CEO Andy Jassy, FDA said it purchased the mole and skin tag remover products from Amazon’s website. The agency also notes that while the products were distributed by Amazon “on behalf of third parties … Each of the products was ‘fulfilled’ by Amazon.”  
On Friday, FDA opened a public docket soliciting feedback on an appendix in its 2018 guidance on ANDA amendments. Specifically, the agency wants stakeholders to comment on the examples of major deficiencies listed in Appendix A of the guidance, and on how any potential revisions to the list could improve industry’s understanding of ANDA amendment classification.
This week, we saw FDA issue an emergency use authorization (EUA) for Bavarian Nordic’s monkeypox vaccine Jynneos to enable healthcare providers to administer the shot intradermally in smaller doses as part of a dose-splitting strategy to stretch the US supply of the vaccine. Other regulators are reportedly looking into the strategy as well, though The Washington Post reports that Bavarian Nordic has reservations about the plan due to “very limited safety data available.”
Last week, FDA launched a new webpage called “Rumor Control” aimed at combating mis- and disinformation, which is one of FDA Commissioner Robert Califf’s stated priorities. The page is currently focused on addressing rumors surrounding COVID-19 vaccines.
We’re also reading more about the Inflation Reduction Act, which the House is expected to vote on later today after the Senate approved in a 51-50 vote on Sunday with Vice President Kamala Harris joining the 50 Democratic senators to break the tie. While the bill contains some healthcare and drug pricing reforms, many of its measures were watered down to win support from moderate Democrats, Politico reports.
Drugs & biologics
FDA granted a new indication to Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations who have received prior systemic therapy. The agency also approved Life Technologies Corporation’s Oncomine Dx Target Test and Guardant Health, Inc.’s Guardant360 CDx as companion diagnostics to the drug.
The agency also gave full approval to Novartis’ Tabrecta (capmatinib) to treat adults with metastatic NSCLC with tumors expressing a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. The drug was previously granted accelerated approval for the indication in May 2020.
FDA announced this week that it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) next month to review Rebiotix Inc.’s biologics license application (BLA) for its live fecal microbiota product intended to reduce the recurrence of Clostridioides difficile infection (CDI) in adults after being treated with antibiotics for recurrent CDI.
Following the discovery of nitrosamine impurity in Merck’s diabetes drugs Januvia (sitagliptin) and Janumet (sitagliptin and metformin HCI), FDA said it will temporarily allow the distribution of the drugs containing Nitroso-STG-19 (NTTP) above the acceptable daily intake limit of 37 ng per day, and it will allow distribution of the drugs with up to 246.7 ng per day of NTTP to avoid potential shortages of the drugs. “Agency scientists evaluated the risk of exposure to NTTP at interim acceptable intake levels up to 246.7 ng per day and determined that it presents minimal additional cancer risk when compared to a lifetime of exposure to NTTP at the 37 ng per day level,” FDA said.
Reuters also reports that Novartis’ gene therapy Zolgensma has caused the deaths of two patients due to liver failure following treatment for spinal muscular atrophy (SMA).
And, Roche announced today that FDA has approved its flu drug Xofluza (baloxavir marboxil) in children 5 to 12 years of age. The company said the treatment is “the first single-dose oral influenza medicine approved in the US for children in this age group.” The agency also approved the drug for post-exposure prophylaxis of influenza for children in the same age range.
Medical devices
FDA is on target to surpass its record for the number of breakthrough device designations issued in single year, according to an analysis by Medtech Dive. With 129 designations granted midway through 2022, the agency is on pace to break the previous record of 206 set in 2021.
As STAT reports, more and more breakthrough devices are making their way to market, with 54 devices with the designation authorized so far, 11 of which were authorized this year.
This week, FDA issued a safety communication advising individuals who use at-home COVID-19 antigen tests to ensure they perform repeat testing 48 hours after their first test to reduce the risk of a false negative result.
FDA also identified Beckton Dickinson’s recall of its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers as a Class I recall. The agency said the recall was prompted by “three separate issues,” which could cause delayed care in critically ill patients who are most likely to require intraosseous access. The agency said it has received 37 complaints about the devices, though no serious injuries or deaths have been reported related to the issues.
Additionally, the agency has revised its list of recognized standards for medical devices. The list contains dozens of modifications, noting instances where a standard has been withdrawn and replaced by a newer version, clarifying the extent of the agency’s recognition of the standard, and noting newly recognized standards.


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