This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more

This Week at FDAThis Week at FDA | 04 November 2022 |  By 

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. To kick off the week, FDA Commissioner Robert Califf tweeted that he and FDA will remain active on Twitter following Tesla CEO Elon Musk’s takeover of the company and concerns about a laxer approach to moderation under Twitter’s new ownership. We also noted FDA’s updated definition of “face-to-face” meetings under the new PDUFA VII program.
 
“The easy thing to do would be to abandon using Twitter, but that’s not the right thing for us to do at this time. More than ever before, it’s 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) exceed the risks.” The FDA chief made the remarks in response to an increase in “divisive and hateful language” that has proliferated on Twitter in recent days.
 
One of the things we learned this week that is sure to impact sponsors of drugs and biologics going forward is the FDA’s updated definition of “face-to-face” formal meetings with industry. The agency said that it considers both in-person and virtual audio/visual meetings on IT platforms to be face-to-face, setting the stage for the agency to continue conducting remote meetings with sponsors going forward. For the time being, all face-to-face meetings will be held virtually.
 
Politico reports that FDA has taken issue with some healthcare providers prescribing the abortion drug mifepristone to patients who are not pregnant. The agency told Politico that advance provision of the drug could be dangerous to patients. The practice is seen by some as a means of providing abortion access in the wake of the Supreme Court’s decision to overturn Roe v. Wade earlier this year.
 
FDA announced an upcoming meeting on Drug Supply Chain Security Act (DSCSA) implementation ahead of the November 2023 deadline for enhanced drug distribution security requirements. The two-day meeting will take place on 7 and 8 December 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 “substantially higher immune response in adults” against circulating variants compared to the original version of the vaccine.
 
FDA also put out a call for more comments on its recent Advancing Premarket Safety Analytics Workshop. The agency received dozens of comments on two documents released for the workshop, though the agency said it wants to get comment on other topics discussed at the workshop.
 
Drugs & biologics
 
FDA this week finalized guidance offering recommendations for cross labeling oncology drugs in combination regimes. The final guidance offers clarity on the agency’s recommendations for the content of the prescribing information section, as well as how dose or dosage modifications for other drugs in the combination should be described.
 
The agency also adopted two final International Council for Harmonisation (ICH) guidelines, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals and M10 Bioanalytical Method Validation and Study Sample Analysis.
 
FDA has published a new final guidance for small businesses that handle human cells, tissues, and cellular and tissue-based products (HCT/Ps). It considers two past rules regarding the use of embryos and which establishments must register with the agency.
 
The Q&A guidance supersedes a 2007 guidance with the same title and incorporates recent rules issued by the agency. Broadly speaking, the guidance tries to clarify the FDA’s oversight of HCT/Ps under federal regulations and explains key terms. Among the most significant changes in the new guidance, it accounts for a 2016 rule that amended certain regulations regarding donor eligibility, including the screening and testing of donors of HCT/Ps. FDA states that under the rule, if an embryo was originally intended for reproductive use for a specific individual or couple, it may be subsequently donated anonymously for reproductive use even if certain requirements are not met. It also considers another 2016 rule that amended regulations around drug establishment registration and drug listing.
 
FDA on Wednesday said it will temporarily exercise enforcement discretion for some of the risk evaluation and mitigation strategy (REMS) requirements for the schizophrenia drug clozapine due to “ongoing difficulties” with the program that have impacted patient access to the drug.
 
Additionally, the agency published a final guidance on user fee rates for the Over-the-Counter Monograph Drug User Fee Act (OMUFA) program. The guidance lists the types of OMUFA fees, their due dates and the exceptions to certain fees, as well as the process for submitting fee payments, the consequences for failing to pay and the process for submitting refund requests or disputing fees.
 
Medtech
 
FDA on Tuesday sent a letter to makers of COVID-19 antigen tests to require labeling updates for repeat or serial testing for such tests offered under emergency use authorization (EUA).
 
We also learned this week that FDA updated its Manufacturer and User Facility Device Experience (MAUDE) Database and openFDA databases to include fields for a device’s unique device identifier-device identifier (UDI-DI) and a modified version of the UDI-Public. The agency said the update “is intended to ensure adverse event information in the databases is searchable.
 
FDA issued two safety communications that affect children this week, including one warning health care providers about a shortage of tracheostomy tubes, such as Bivona tracheostomy tubes manufactured by ICU Medical. The agency said children are likely to be most impacted by the shortage because alternative tubes with similar functionality may be limited.
 
The agency also issued a strong warning about using infant head-shaping pillows 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 using the pillows could result in sudden unexpected infant death (SUID). People who own such a pillow should immediately dispose of them, FDA said.
 
FDA announced that Teleflex is recalling several types of its ISO-Gard Filter S, a breathing circuit bacterial filter, due to the risk of splitting and/or detaching from the respiratory equipment or breathing systems they are connected to. If that happens, the agency said the filter may not work properly or efficiently that may cause serious injury or death to patients.

 

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