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CMS will make a written initial offer to the Primary Manufacturer with the proposal for the maximum fair price (MFP) for a selected drug for initial price applicability year 2026 no later than February 1, 2024. After the written initial offer from CMS, the Primary Manufacturer has the option to submit a written counteroffer. For more information, please see our fact sheet on the process for negotiation.
As described in sections 40.2.1 and 40.2.2 of the revised guidance, CMS is committed to protecting confidential and proprietary information obtained from manufacturers throughout the negotiation process. CMS will not publicly discuss ongoing negotiations prior to the release of the explanation of the MFP unless a Primary Manufacturer publicly discloses information regarding the negotiation process – this includes the initial offer. Primary Manufacturers may choose to publicly disclose information regarding ongoing negotiations at their discretion. CMS will publish a public explanation of the MFP for the selected drug list by March 1, 2025, that will include a narrative explanation of the negotiation process, the agreed-upon MFP, and redacted information regarding the section 1194(e) data received, exchange of offers and counteroffers, and the negotiation meetings, if applicable. For more information, please see our fact sheet summarizing the revised guidance.
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Novo Nordisk intends to evaluate CMS’s initial offer and will decide how to respond. The information provided by Novo Nordisk to CMS is confidential, and once the process has concluded, CMS will make public the maximum fair price it sets for the relevant products.
Attributable to: Jonathan Mermin, M.D., M.P.H., director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.
What is known about why syphilis cases previously decreased in the 1950s and 1990s: The availability of penicillin played a role in reductions that started in the late-1940s. And we know reductions in the 90s were at least in part due to changes in sexual behaviors due to the HIV epidemic.
However, the current increases in syphilis are being driven by several factors, so it’s going to take multiple solutions to turn the epidemic around. Some of these driving factors include:
reductions in STI services at the state and local level; increases in substance use, which has been linked to less safe sexual practices; ongoing social and economic conditions that make it more difficult for some populations to avoid STIs; decreases in condom use; challenges stemming from the fact that STIs continue to be stigmatized – stigma buries the truth that all people deserve quality sexual healthcare to live healthy lives and it can deter people from taking action to prevent and treat STIs. Controlling syphilis and other sexually transmitted infections (STIs) requires robust public health systems and workforces, and prevention strategies that are tailored to the specific needs of affected communities. There are no shortcuts to syphilis control.
Additionally, the vast majority (86%) of syphilis cases were diagnosed outside of STI clinics in 2022. Health workers in a variety of settings – including primary care, emergency departments, community health, correctional, and drug treatment programs – can play a vital role in stopping the syphilis epidemic when they expand efforts to test and treat people for syphilis.
And while the STI field saw several promising innovations and actions in the past year (e.g., National Syphilis Federal Task Force, CDC Doxy PEP draft guidelines, FDA authorizing first at-home test for gonorrhea and chlamydia), there are still several gaps left to fill to develop the right mix of syphilis testing, prevention, and treatment solutions for more people.
Expanding syphilis cases beyond MSM demographics? We know that syphilis in the heterosexual population and drug use, particularly methamphetamine use, are intersecting epidemics, and syphilis has spread among heterosexual men and women for decades.
Additional background
Rates of primary and secondary (P&S) syphilis among women have increased since 2013. During 2021 to 2022, the national rate of P&S syphilis among women increased 19 %. These increases among women are concurrent with increases in cases among heterosexual men, reflecting an expanding heterosexual syphilis epidemic in the United States. Additionally, gay and bisexual men continue to be disproportionately impacted by syphilis, accounting for almost half (45 %) of all male P&S syphilis cases in 2022. During 2021 to 2022, the number of cases of P&S syphilis among MSM increased 4.0%.
Helpful graphic here.
Why divergence from gonorrhea/chlamydia warrants further investigation State and territorial health departments sent more than 2.5 million diagnosed cases of gonorrhea, chlamydia, and syphilis to CDC in 2022. While reported syphilis cases continued to increase between 2021 and 2022, reported chlamydia cases stayed consistent and reported gonorrhea cases declined by nearly 9%. We’re cautiously optimistic about the gonorrhea data. Given this is the first drop in reported gonorrhea cases in at least a decade, CDC is examining this finding closely and will be looking to final 2023 data to better understand if this signals a decline in infections and to better understand where, why, and among whom the decrease occurred with the hope we can expand on what’s working.
2024-01-29_fda_foia-2023-11303-1.pdf
2024-01-29_fda_foia-2023-11303-2.pdf
2024-01-29_fda_foia-2023-11303-3.pdf
2024-01-29_fda_foia-2023-11303-4.pdf
2024-01-29_fda_foia-2023-11303-5.pdf
2024-01-29_fda_foia-2023-11303-6.pdf
2024-01-29_fda_foia-2023-11303-7.pdf
Thanks for your patience on this. Please see response below.
2023: 5 cases
2022: fewer than 5
2021: fewer than 5
2020: fewer than 5
2019: 6 cases
2018: fewer than 5
Joseph Miller, CDC [00:49:38]
So the goal of the ICATT program, largely I think if you try to put it under one umbrella, it’s changed over time. But it’s really to provide, I think, equitable health services to underprivileged communities during outbreak scenarios. And we do that through pharmacy partnerships.
And so we really have four missions or sub goals.
They are one, to provide equitable diagnostic testing for COVID or at risk communities. And we focus on medical necessity and uninsured populations, medical necessity, meaning people that are symptomatic.
We also provide surge testing for states and local jurisdictions when there’s a lot of demand for testing. However, we haven’t done this in a couple years and we don’t intend to do it anytime soon. But it’s a capability that we have within our contracts.
We also provide testing to unaccompanied minors along the Southern border. This activity we anticipate will wind down over the next year.
And then we also, uh, partner with the Bridge Access Program who provides COVID vaccines to the uninsured and underinsured. And we serve as the sort of the conduit between the Bridge program and the pharmacies. We provide contracting support, budget support, financial support, quality and data support as well to the that program.
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Joseph Miller, CDC [00:52:48]
We have testing sites in all 50 states, including DC and Puerto Rico. We have about 10,000 active testing sites and any given week, about 2,000, 2,500 sites are testing. And we do anywhere from five to 10,000 tests per week.
We prioritize sites in terms of social vulnerability, urbanity, and also access, easy access to testing and our testing sites primarily include now pharmacies and clinics.
Historically we had, you know, as you can read here, like retail sites and firehouses and police stations and libraries, but for the large part, we’ve sort of pulled back from that and are now focusing on testing and pharmacies and clinics.
Through these contracts, we’re able to do antigen tests, and NAAT tests that are point of care tests, also laboratory tests, flu COVID multiplex tests. And we do a little bit of over the counter tests, but that’s really just in a collaboration with NIH. But we have those capabilities.
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Joseph Miller, CDC [00:54:33]
We also support testing along the Southern border. So we have about eight sites,that’s seven CBP sites or Customs and Border Patrol sites, and one ICF site, which is an influx care facility.
These are sites that hold children that have illegally crossed the border. And we perform testing in those sites as the children pass through ORR or CBP custody.
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Joseph Miller, CDC [00:55:09]
So currently 24,000 sites are enrolled with ICATT to do vaccinations as part of the Bridge Access Program. And I think to date about 20,000 of those 24,000 sites have actually administered vaccines.
And I think we’re almost, I think we’re butting up to about close to doing about a million vaccines in that program somewhere around 700,000 or so.
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Joseph Miller, CDC [00:59:56]
ICATT is a very data driven program. We get tons and tons of data.
So we have, like I said, about 50 million lines of data. We collect data on a daily basis from our vendors. So we collect testing data and vaccination data, probably multiple times a week. We then take that data and we display it internally and externally on dashboards. So it’s displayed to our state partners and also to partners across the CDC and across the federal government.
A lot of our data is used for things like surveillance, research projects, understanding what the current operating picture is for COVID. We look at vaccine effectiveness, we track different strains or try to detect new strains of COVID, etc.
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Joseph Miller, CDC [01:07:27]
So we have funding through May 2025, but after that, our funding is not clear. Next slide.
So I just wanted to talk a little bit about the assets of the ICATT program. So, what do we have that’s sort of at stake or what do we have to sort of figure out what we do or don’t do it? We’ve got testing sites. They take a long time to set up this network and connect them to data systems.
The cost of rebuilding in terms of funding we’re estimating, it’s probably– it’s probably south of 50 million dollars. It’s probably somewhere between 10 to 50 million dollars.
If we were to say, all right, let’s just put this on the shelf and, pull it off the shelf and rebuild it for the next pandemic, you’re looking at sort of tens of millions of dollars, I think, to do that. Somewhere between like 10 and 50.
Just staffing alone is three million dollars a year, just for government staff. And then contractors at, potentially one to two of that.
During the pandemic, we used about three billion dollars of funding to sort of put it in scale about what it costs to build the program and run it and what it might cost to maintain it, which is probably, I think maintaining, it would be in the low single digit million dollars, millions of dollars per year, closer to zero than 10.
We have a lot of trust with our, our pharmacy partners. I think we’re able to do things with them that other government agencies would probably struggle to do, because we just built a lot of trust and personal relationships over the last three years.
We have contracts that have– we’ve done three rounds of contracts, and we think we’re like almost to the point where we have like a perfect contract. Contracting is so difficult to really plan for everything ahead of time. But these are contracts that change over time. And I think, they’re night and day from where we initially started and they’re extremely complex and restarting. Those would take a lot of effort.
And we have data systems. This is– would be the, a lot of the cost of rebuilding the program.
And then sort of the knowledge base. We have a group of people that know a lot about pharmacies and how they operate, we know the difference between insurance systems for medical benefits and pharmacy benefits, how they’re processed and you know, what they’re good for and not good for. And so I think that a lot of that would be lost if we had to shelve the program.
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Joseph Miller, CDC [01:10:48]
And so some questions that I have for folks here are, where does this program, if it fits within the agency, where would it best fit? How should this program scale in terms of capabilities and scope and people, after contracts expire in 2025?
Does the warm based strategy makes sense for ICATT? Or should it be sort of a book that you pull off the shelf as opposed to one that you read, from time to time.
If we do a warm based strategy, what do we do, which kind of activities would be best to pursue, during peace time, when ICATT is not in the response mode?
What should the scope be for the ICATT program in terms of testing and vaccination, therapeutics, telemedicine, etc? Should we continue to support the uninsured or should it be broader than supporting the uninsured?
What are other pathogens that we can think about including in this program and how might we leverage partnerships with other federal state and local governments or departments of health, and I’ll put it in there academics as well.
Several bottles of Neptune’s Fix were tested. Substances identified included tianeptine, kava, two synthetic cannabinoids, and two plant cannabinoids.
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Not all of the bottles contained all of the listed substances; however, all of them did contain tianeptine.
The Pittsburgh Poison Center at UPMC has had only occasional calls related to Neptune’s fix. Nothing significant or urgent in nature.
Neptune Resources LLC did NOT have a single serious injure/illness reported. Every serious illness reported was from a counterfeit product made by a New York-based company called Super Chill.
My understanding is that their counterfeit product did NOT even contain tianeptine as the label indicated; instead it contained one of the new synthetic cannabinoids and bromazepam.
I have plenty of proof that Super Chill is the manufacturer of the counterfeit products that have hurt people but I have had difficulty convincing the FDA to shift their attention to the counterfeiter.
We have had 3 calls from January 2023 to today specifically indicating they took Neptune’s Fix, but 13 calls total from January 2023 to today for tianeptine in general.
Calls to our helpline, 1-800-222-1222, can come from anywhere in our 54-county coverage area - including from a home or a healthcare facility.
Tianeptine is not available in the United States as an approved drug. It is sold as a dietary supplement with claims it improves brain function and treats anxiety, depression, and opioid use disorder.
Jeanna Marraffa, PharmD, Clinical Director of the Upstate New York Poison Center, says, “Our poison center recommends avoiding products containing tianeptine. Severe side effects include sleepiness, confusion, agitation, slowed breathing, and even coma. Contact your doctor for opioid dependence, anxiety, or depression treatment. However, the Upstate New York Poison Center is available 24/7/365 to take your calls with questions or concerns. All calls are free and confidential.”
Thank you for reaching out. Please see the data below for all tianeptine exposures. We are not able to provide data specific to Neptune’s Fix.
Most cases of tianeptine exposures reported to U.S. Poison Centers involved adults intentionally using the substance to get high. Symptoms reported range from agitation, increased heart rate, and confusion to more severe symptoms similar to opioid toxicity including sedation, respiratory depression, and slowed heart rate. Please cite America’s Poison Centers as the source for this data.
Human Exposures Involving Tianeptine Reported to U.S. Poison Centers, January 1, 2019 - December 31, 2023
Year Case Count
2019 105
2020 151
2021 210
2022 246
2023 391
I would also ask that you include our Poison Help phone number and website as a resource. Here is suggested language: “If you have question about tianeptine, or need emergency assistance contact Poison Help at 1-800-222-1222 or visit PoisonHelp.org for additional resources.”
On Background:
In response to the lead-tainted applesauce recall, the Department of Public Health (DPH) Childhood Lead Poisoning Prevention Program (CLPPP) last year conducted targeted outreach to warn parents not to buy or use recalled lead-tainted applesauce puree pouches.
CLPPP sent out a notice on the Health and Homeland Alert Network (HHAN) to clinicians and local health departments, and informed DPH’s Women Infants and Children’s program and the Department of Early Education and Childcare about the recall.
DPH’s Food Protection Program staff reviewed FDA’s inventory of Dollar Tree stores, where these products were sold, and worked closely with local boards of health to follow-up with various municipalities to track product removal from shelves.
Using CDC’s definition of potential cases, CLPPP case management staff identified five poisoned children potentially linked to consumption of the recalled products and reported the cases to CDC. CDC guidance recommends including cases where suspected consumption was within three months of the associated blood test; therefore, it’s difficult to determine if the potential exposure occurred before or after the recall announcement.
Eduardo Azziz-Baumgartner, CDC [00:16:57]
In this map, you see changes in hospital admissions attributed to COVID 19. Green means that there’s been a decrease compared to previous weeks, and orange means that there’s been an increase in admissions, again, attributed to COVID 19, how much greener the map is on the January 13th cut.
So that’s good news, that’s compared to January 6th, hospitalizations. But they seem to have stabilized pretty much. And, we have to be careful though about making too many inferences about that because we could see an uptick again of cases, as adults return to work, after the holidays and children returned to school, after the winter holidays.
We have to wait and see.
Next slide, please. All right.
Let’s see here, you see a steep flu COVID and RSV hospitalization rate that curbs up, per a hundred thousand population, in December. That seems to have come to a halt in those gray boxes. It seems to have stalled and halted. So it may be trending down that inflection point, however, it is within the gray bars, that gray box again of uncertainty.
We have to wait to see if those trends, if that pattern continues, whether it continues to trend down, or if there’s back filling of information that suggests that we’re creeping up again after a little notch or divot on the curve.
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Eduardo Azziz-Baumgartner, CDC [00:18:54]
Here on the table on the left and on the figure on the right, you’ll notice that the percentage of available inpatient bed and ICU beds that are occupied, the encumbered beds, you can see in the purple line in that figure, the inpatient ward beds that are occupied by adults is close to 78% and with really little room for additional admissions.
Similarly, you see in the green line, the inpatient beds that are occupied by children is at 69%, again, not a lot of room for additional admissions.
And we’re hearing from some jurisdictions in New England, for example, in Massachusetts, that they’re really having a hard time with using all their bed capacity.
Now, this is after a drop in the holidays in bed occupancy. This is not uncommon during the holidays, for the bed occupancy to go down a little bit again because of health utilization patterns. But we don’t know if this is going to be a– where the trend is going, where the pattern is going to go beyond the gray box of uncertainty.
Again, what we know is that it has increased in the wards for both adults and children and, among adults in ICU beds, although the pediatric ICU admissions currently remains stable.
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Eduardo Azziz-Baumgartner, CDC [00:22:18]
We really depend on biologic surveillance during the season to guide response, not only to from week to week to really tailor messages to the community, to fine tune how we respond to the viruses, not only at the local jurisdictions that you do with your own leadership, but here also at CDC and in other parts of HHS.
Now, it is important to note that one of the key measures that we track is for example, present positivity, percent of laboratory testing that turns out to be positive. We look for detection of novel viruses. You heard, of course, the JN.1 presentation from my colleague.
And then, we also look for information that will help us with strain selection for what goes into the vaccines from these viral systems, and surveillance systems. And then we also look for antiviral resistance so that we can guide, help our clinicians stay informed about what antiviral work for which viruses and when they stop working as has happened historically, for flu for example.
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Question [00:27:19]
Maybe you can address this is whether or not the symptoms with the new variant seem to be more severe or, or not?
Eduardo Azziz-Baumgartner, CDC [00:27:28]
Yeah, that’s a really important question. And it looks like from the deep surveillance systems that are going that these electronic medical record cohorts and whatnot, there are early signals that that may not be the case, but we don’t know yet.
And so we’re going to have increase– the data’s going to accrue during the next couple weeks, and hopefully we’ll be able to get a better information out to our colleagues about the severity of JN.1. It doesn’t look like it, it doesn’t look like it.
Now, it’s important to remember that how a virus affects an individual is a unique– an n of one, right? It could be very severe. People could die from a virus that, to the general population, may be milder. But it can still. These viruses can kill.
It’s important to remember. So please do contact medical providers if you need to, and take care of your people please.
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Eduardo Azziz-Baumgartner, CDC [00:31:31]
There is some preliminary data that suggests that co-infections may be associated with more severe disease, but the data’s inconclusive. And, and I think we’re still trying to understand this.
And part of the reason that is complicated is because we rely a lot on observational data for these findings, because it’s not a common occurrence, but let’s get back to you on that, please.
From: Charla Haley (DHHS)
Sent: Monday, January 22, 2024 11:07 AM
To: Tin, Alex
Subject: Re: Question about lead applesauce poisonings
They are from exposures from last year.
Charla Haley
Public information officer
...
On Mon, Jan 22, 2024 at 9:01 AM Tin, Alex wrote:
Thanks for getting back to me.
Do you know when was the most recent exposure?
Curious if it's the result of a recent exposure from after the recall, or just case finding resulting from an exposure that happened last year.
Alexander Tin
... < br>
From: Charla Haley (DHHS)
Sent: Monday, January 22, 2024 10:58 AM
To: Tin, Alex
Subject: Re: Question about lead applesauce poisonings
External Email
We have 2 confirmed cases in Utah.
Charla Haley
Public information officer
The increase in case counts reflects newly reported cases, for which the time of applesauce consumption varies. There is still ongoing outreach to find new cases at this time, and communication efforts to spread awareness of the dangers of these products are focused on preventing future exposures. Additionally, FDA is working with retailers to ensure that all products have been removed from shelves, and they would be the appropriate contact for updates to the recall work.
CDC’s immediate recommendations are to avoid eating cinnamon-containing apple purée or applesauce products included in the FDA recall announcements. Anyone who may have eaten the affected products should talk with their healthcare provider and get a blood test for lead.
I can share that as of January 2, approximately 55,000 pharmacies are contracted and online with the ability to participate in the Patient Assistance Program. These pharmacies are represented across all 50 states and represent a significant portion of historical PAXLOVID volume. This includes retail chains such as CVS, Walgreens, Walmart, Kroger, Costco, H-E-B, Albertson’s, Meijer at this time, along with a number of independent pharmacies across the country. Additionally, contracts are being signed and pharmacies coming online on an ongoing basis, so this number will continue to increase. And, if a patient seeks to fill the PAXLOVID prescription at a pharmacy not participating in the USG PAP, or if a pharmacy does not have PAXLOVID inventory, overnight shipping to the patient’s home is also available.
“The submission in question was unable to be verified, despite follow-ups by NIH to the Chinese scientist for more information and a response. While waiting for the submitter to provide information to verify the sequence, another submission of a nearly identical sequence but with verifiable details was submitted to GenBank by another group and verified for inclusion on January 12, 2020, providing the genetic sequence for SARS-CoV-2. This publicly available information was what was used by NIH scientists and others in their work to understand the origins of COVID-19.
“We agree that valuable, bipartisan work remains to address the Chinese government’s lack of transparency and ensure investigators can access critical information about the origin of COVID-19, so we can better understand how to prevent future pandemics.
“HHS has consistently and voluntarily provided Congress with thousands of pages of documents, as well as the expertise of officials, as part of its effort to promote transparency and understanding on the origins of COVID-19.”
“As we’ve said before, HHS has concluded their independent review, guided by the evidence. These documents reflect HHS’ evaluation of the scientific and medical evidence and its scheduling recommendation to DOJ. The scheduling review is now with DOJ.”
Meghan Pennini, ASPR [00:14:10]
Bottom line is no one should be paying full price for Paxlovid. There are programs in place to ensure that, unless they choose to right, if somebody wants to pay, of course they can, if they don’t want to enroll or they don’t want to leverage these programs, they can. But we really want to emphasize that the best way to make sure, especially as everybody’s getting educated and, things are ramping up, the best way to ensure that you really get the best no cost or very low cost Paxlovid is that you enroll ahead of time, right?
You go to the webpage, you’ll be directed to which program is right for you, and you walk into the pharmacy with the paperwork that says this is the program I fall under, and this is how I get my product.
So of course it can also happen at the pharmacy counter, right, where things are, are ramping up and, payers and pharmacies are getting all on board.
But again, the best way to just ensure, especially in this time period, is to take that initiative for your patient. You know, we want providers to be aware of that. We want the public to be aware of that. We want the pharmacies, everybody right across the board to be aware of that program.
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Meghan Pennini, ASPR [00:19:39]
Just to go back to the point of the patient journey, and we appreciate right that we want to make this as seamless as possible. We also want to make sure that there’s broad access. And so that’s why we set up these programs.
But just to be clear, it should work at the counter. That’s the goal. We’re trying to make sure that gets implemented, so it’s a seamless process for the patient, but again, especially in this time of transition, it’s good to take the initiative when you can, and do that enrollment ahead of time.
But, but I just– I don’t want to belittle the efforts, monumental efforts, that our pharmacy teams and payer teams are doing to make this a seamless process sort of on the back end, so patients don’t even notice.
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Meghan Pennini, ASPR [00:19:39]
Just to go back to the point of the patient journey, and we appreciate right that we want to make this as seamless as possible. We also want to make sure that there’s broad access. And so that’s why we set up these programs.
But just to be clear, it should work at the counter. That’s the goal. We’re trying to make sure that gets implemented, so it’s a seamless process for the patient, but again, especially in this time of transition, it’s good to take the initiative when you can, and do that enrollment ahead of time.
But, but I just– I don’t want to belittle the efforts, monumental efforts, that our pharmacy teams and payer teams are doing to make this a seamless process sort of on the back end, so patients don’t even notice.
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Question [00:23:43]
With Paxcess, what are you seeing in terms of enrollment? Is the participation where you would like it to be?
Meghan Pennini, ASPR [00:23:52]
Yeah, so I can say, it’s still in early days.
What I didn’t get a chance to mention, and thank you for the opportunity, is there still is a lot of fully free USG distributed product out there sitting in pharmacies. And so, it will take a little bit of time.
It’s millions of patient courses. So it will take time for that to get used up, which is great, right? You can still find places where you can get absolutely free, no enrollment, nothing, product. And so until that really is drawn down, we won’t start to see these other programs being leveraged as heavily.
But I will say we know that it’s being used now. It’s really in the– but not to the full extent, because obviously there’s still this EUA product and people are being advised to use that up first, and then transition to the commercial product, which then you have to start leveraging these programs.
So we know it works, but it’s not getting used in high volumes as expected, because we’re still using that fully free USG distributed product.
There has not been a pause in the reporting of healthcare personnel vaccination data. CDC is still receiving these data. Posting of the healthcare personnel vaccination has been temporarily paused for the week of January 1-7, 2024, while we transition from collecting primary series and up-to-date vaccinations to only collecting up-to-date vaccination data.
This change is in accordance with the CMS quality reporting program measure updates.
Unlike BLA’s which have clear timelines and PDUFA dates, the EUA pathway does not have a pre-specified ‘review clock’ so we are not able to provide any guidance on the potential timing.
Nirsevimab Administration
A huge thank you to all clinics administering nirsevimab. Despite the challenges and limited allocations, almost 50% of infants younger than 8 months have been immunized against RSV. Thank you for helping protect the most vulnerable. Beginning January 10, CDC will post monthly national estimates of nirsevimab receipt among children <8 months on RSVVaxView CDC. These will be based on parental report from the National Immunization Survey. If your clinic still has doses on hand, please administer them. We are over halfway through the RSV season and doses administered now will offer the most protection to babies.
Paxlovid, an oral antiviral for COVID-19, is now available on the commercial market and the U.S. Government is winding down distribution of free oral antivirals. Medicare Part D enrollees can still obtain free Paxlovid through two pathways, either through their Part D plans or through Paxcess, Pfizer’s patient assistance program.
Has Medicare conducted any outreach to beneficiaries regarding eligibility for the Paxcess program for Paxlovid?
CMS and HHS continue to conduct outreach to our pharmacy, Part D sponsor, and pharmacy benefit manager partners to ensure smooth access to Paxlovid for Medicare enrollees.
Are Part D plans required to inform members of the option
CMS encourages Part D sponsors to provide education and outreach to their enrollees and network pharmacies regarding whether the Part D sponsor will contract with Pfizer to offer Paxlovid at $0 cost sharing through the Part D plan, or instead, encourage enrollees and network pharmacies to utilize the standalone USG PAP operated by Pfizer.
For more information, please see the attached January 4, 2024 memo from CMS to Part D sponsors.
Following rigorous study for many years in clinical trials and a robust approval process, medicines continue to be monitored by the FDA and manufacturer for safety. When the FDA identifies a potential safety issue, it creates a Newly Identified Safety Signal (NISS) for evaluation. Currently, the FDA is reviewing data on certain potential risks for GLP-1 receptor agonist medicines. Patient safety is our priority, and we are collaborating with the FDA on these potential signals.
The FDA monitors the safety of drugs throughout their life cycle, including post-approval. In addition, the FDA maintains a system of postmarketing surveillance and risk assessment programs to identify and evaluate adverse events that did not appear during the drug development process. If newly identified safety signals are identified, the FDA will determine what, if any, actions are appropriate after a thorough review of available data.
Patient safety is the top priority for Novo Nordisk. Novo Nordisk works closely with the U.S. Food and Drug Administration (FDA) to continuously monitor the safety of all of our GLP-1RA medicines. We are aware that, as part of those monitoring efforts, FDA is evaluating several potential signals related to GLP-1RA medicines and has posted information about those ongoing assessments on its website. As FDA stated on its website, “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.” The known risks associated with use of those medicines are reflected in their current FDA-approved product labeling. Novo Nordisk stands behind the safety and efficacy of all of our GLP-1RA medicines when they are used as indicated and when they are taken under the care of a licensed healthcare professional.
As the inspection is ongoing, we are not able to provide a timeline for completion. For the latest updates please visit the infant formula recall alert webpage and the Constituent Update webpage.
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it’s not just the cans that were produced around the same time that turned up no signs of contamination. All tests conducted by the FDA have been negative, including the sample from the batch made for Israel.
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The FDA has also conducted an inspection at the facility where both the batches were produced, including collecting environmental samples . All tests performed by the FDA were negative. The factory continues to operate at full capacity. However, Reckitt/Mead Johnson understands the incredible responsibility we have in providing what is often the sole nutrition for infants, and there can be no short cuts for this vulnerable population – therefore, we chose to recall select batches of Nutramigen out of an abundance of caution. Parents should be reassured that they can continue to feed their infants with Reckitt/Mead Johnson Nutrition products, including other Nutramigen powder formula batches, with confidence.
We are continuing to advance our long-acting antibody AZD3152 to help protect vulnerable patients like the immunocompromised who face up to 14x greater risk of hospitalisation from COVID-19 than the general population, even after repeated doses of COVID-19 vaccines.
The Phase III efficacy trial is now fully enrolled; the trial will assess the potential benefit of AZD3152 in protecting immunocompromised patients in an environment with many variants in circulation.
We aim to make AZD3152 available as a new option for COVID-19 as quickly as possible subject to trial readouts and regulatory reviews.