“The easy thing to do would be to quit using Twitter, but that’s not the right thing for us to do at this time. More than ever before, it is important that FDA continues to use Twitter for good and do everything in our power to protect the public from potential harm,” Califf said, adding that “the potential benefits (of staying on Twitter) outweigh the risks.” The FDA chief made the comments in response to an increase in “divisive and hate speech” that has spread on Twitter in recent days.
One of the things we learned this week that will likely affect drug and biologics sponsors going forward is the FDA’s updated definition of formal “face-to-face” meetings with industry. The agency said it considers in-person and virtual audio/visual meetings on IT platforms as face-to-face, setting the stage for the agency to continue conducting remote meetings with sponsors going forward. For now, all face-to-face meetings will take place virtually.
political reports that the FDA has taken issue with some health care providers prescribing the abortion drug mifepristone to patients who are not pregnant. the agency said political that the advance provision of the drug can be dangerous for patients. The practice is seen by some as a means of providing access to abortion after the Supreme Court’s decision to overturn Roe v. Wade earlier this year.
The FDA announced an upcoming meeting on Drug Supply Chain Security Act Implementation (DSCSA) before the November 2023 deadline for enhanced drug distribution security requirements. The two-day meeting will take place on December 7 and 8, 2022.
Pfizer and BioNTech on Friday provided an update on their bivalent COVID-19 vaccine targeting the Omicron BA.4/5 subvariants. The companies said the updated booster demonstrates “significantly higher immune responses in adults” against circulating variants compared to the original version of the vaccine.
The FDA also put out a call for more comments at its recent Premarket Safety Analytics Advancing Workshop. The agency received dozens of comments on two documents released for the workshop, though the agency said it would like to receive comments on other topics discussed at the workshop.
Drugs and biologicals
The FDA this week finalized guidance that provides recommendations for cross-labeling oncology drugs in combination regimens. The final guidance provides clarity on the agency’s recommendations for the content of the prescribing information section, as well as how dose or dose modifications for other drugs in the combination should be described.
The Agency also adopted two final International Council for Harmonization (ICH) guidelines, Appendix S1B(R1) to S1B Testing for Carcinogenicity of Pharmaceutical Products AND M10 Bioanalytical method validation and study sample analysis.
The FDA has published new final guidance for small businesses handling human cells, tissues, and cell and tissue-based products (HCT/Ps). It considers two past rules regarding the use of embryos and which institutions must register with the agency.
The Q&A guidance replaces a 2007 guidance with the same title and incorporates the latest rules issued by the agency. Overall, the guidance attempts to clarify FDA’s oversight of HCT/Ps under federal regulations and explains key terms. Among the most significant changes in the new guidance, it counts a 2016 rule that changed certain regulations related to donor eligibility, including the screening and testing of HCT/Ps donors. The FDA states that under the rule, if an embryo was originally intended for reproductive use for a specific individual or couple, it can then be donated anonymously for reproductive use even if certain requirements are not met. It also takes into account another 2016 rule that changed regulations around drugstore registration and drug listing.
The FDA said Wednesday it will temporarily exercise enforcement discretion on some of the risk evaluation and mitigation strategy (REMS) requirements for the schizophrenia drug clozapine because of “ongoing difficulties” with the program that have affected patient access to medicine.
Additionally, the agency published final guidance on user fees for the Nonprescription Drug Monograph User Fee Act (OMUFA) program. The guidance lists the types of OMUFA fees, their due dates and exemptions from certain fees, as well as the process for submitting fee payments, the consequences for non-payment and the process for submitting refund requests or contesting fees.
Medtech
The FDA on Tuesday sent a letter to makers of COVID-19 antigen tests to request labeling updates for repeat or serial testing for such tests offered under emergency use authorization (EUA).
We also learned this week that the FDA updated its Manufacturer and User Device Experience (MAUDE) database and open FDA databases to include fields for the unique device identifier (UDI-DI) and a modified version of UDI-Public. The agency said the update “is intended to ensure that adverse event information in databases is searchable.
The FDA issued two safety communications affecting children this week, including a warning to health care providers about the shortage of tracheostomy tubes, such as Bivona tracheostomy tubes manufactured by ICU Medical. The agency said children are likely to be most affected by the shortage because alternative tubes with similar functionality may be limited.
The agency also issued a strong warning about the use of baby head-shaping pillows that are intended to change the shape of a child’s head to treat certain medical conditions. The agency said that not only is there no evidence for such claims, but that the use of pillows can result in sudden infant death syndrome (SUID). People who have such a pad should throw it away immediately, the FDA said.
The FDA announced that Teleflex is recalling certain types of ISO-Gard Filter S, a bacterial respiratory circuit filter, due to the risk of separation and/or detachment from the respiratory equipment or breathing systems to which they are attached. If that happens, the agency said, the filter may not work properly or efficiently, which could cause serious injury or death to patients.
