A busy month in the pharmaceutical industry is coming up- POLITICO

— The Senate plans to increase the bill for user fees for June 8, in a busy month for your FDA reporters.

— The FDA’s Twitter account balances memes with more serious tweets. The agency’s social media director tells us more about its content strategy.

— Pfizer and BioNTech Complete EUA Application for a Covid-19 vaccine for children under 5.

It’s Friday. Welcome back to Prescription pulse. Your co-host’s pup is a heavily vaccinated dog after a visit to the vet this week.

Send tips and feedback to David Lim ([email protected] Where @davidalim), Lauren Gardner ([email protected] Where @Gardner_LM) or Katherine Ellen Foley ([email protected] Where @katherineefoley).

SENATE AID COMMITTEE TO MARK USER FEES INVOICE The Senate HELP Committee has has officially provided a markup of the House bill to reauthorize user fees for FDA medical products next Wednesday, June 8, from 10 a.m. In addition to the user fee bill, the commission will mark legislation to improve access to mobile health care clinics.

June promises to be an eventful month in the pharmaceutical world. Let your hosts break it down for you so you have a handy guide for the weeks ahead:

VRBPAC-palooza: The FDA’s Vaccines and Related Biologicals Advisory Committee has four meetings scheduled, with the first taking place on Tuesday, June 7, as experts assess whether to grant emergency use authorization to Novavax’s Covid-19 vaccine. We will go deeper in this next issue.

June 14 and June 15 are Pediatric Vaccination Days, with the first day dedicated to Moderna’s attempt to vaccinate children aged 6-17 and the second to Moderna and Pfizer’s apps to offer vaccinations to children as young as 6 months old. During a Thursday press briefing, White House Covid-19 response coordinator Ashish Jha said he expects the youngest children to be able to receive their first doses of the vaccine from June 21st as soon as possible.

And on June 28, FDA expert advisers will dig into the big question mark hanging over Covid vaccines — whether to sanction a change in vaccine strain composition in time for a fall vaccination campaign.

Listening sessions on banning menthol cigarettes: In April, the FDA made long-awaited proposals ban the sale of flavored cigars and menthol cigarettes. Menthol cigarettes are primarily used by black smokers and account for about a third of all cigarette sales. But the proposed ban has raised concerns, particularly among black leaders and some black lawmakers, who fear that a ban on menthol cigarettes — even if it targets manufacturers — would lead to increased policing of black individuals and communities.

The FDA has scheduled two listening sessions on June 13 and June 15 to hear concerns about the proposed rules.

Enforcement of big pharma antitrust rules: The Federal Trade Commission has announced that it will hold a meeting covering June 14 and June 15 to discuss how plans to apply antitrust laws in the pharmaceutical world.

ALS Medication Decision: The FDA is expected to decide the fate of a drug for amyotrophic lateral sclerosis, or ALS, from Amylyx by June 29. Patient advocacy groups have tried to pressure the FDA and Congress to greenlight the drug due to the lack of treatments for the deadly disease, but the agency’s external advisory board voted against approving the drug in March.

HOW FDA TWEETS BALANCE MEMES WITH SERIOUS BUSINESSThe FDA’s Twitter star has shone brightly throughout the pandemic, with the agency’s account going from standard government press release fare to cheeky pop culture references. And how could anyone forget the regulator’s warning that sensitive consumers of social media are not, in fact, horses?

Lauren spoke with FDA social media director Brad Kimberly about her content strategy, including her affinity for retweeting professional wrestlers. The conversation, a version of which appeared in POLITICO Nightly, is edited for space and clarity.

OK, so you’re responsible for the “you’re not a horse”?

Yes. I realized these words.

Why did you decide to mix humor with seriousness? Has your approach changed during the pandemic or have you always been that meme-y?

The pandemic has given us the opportunity to speak to people a little more directly. Over the past year, we’ve really focused on speaking to the first person of the FDA account – the FDA account is a personality – and we want to be able to communicate with people in a way that they can understand.

We are quite scientific; there’s a lot of complicated messages we’re trying to get across, and not everyone has an MD or a PhD. So how do I communicate these complicated ideas to the masses? How can I make my mother understand them?

Who is your target audience?

We want to draw attention to many issues – using humor to maybe poke fun at the use of vet-grade ivermectin a little in an effort to get people to stop using it. It’s definitely not how we would normally talk. But it made a huge difference.

Misinformation about ivermectin on social media has really taken a nosedive. I think people started to see it as, OK, yeah, it’s kinda silly to eat horse paste. So it’s nice to be able to have that kind of effect, but also getting that kind of awareness also gets people to come and see our account, and so they’ll not only see the humorous stuff, but also the serious business.

How do you walk that line between using humor to convey important public health information and not trying to appear flippant?

When it comes to internet celebrations or holidays, I think we have a lot more leeway to take that creatively – where I can say things about May 4, on Star Wars Day, about “use of force is not a Covid prevention measure” as a way to relate to a trending topic, so people see it but also communicate the message of the FDA in a smart way. If there are people [who] are affected by something happening in the world that we have a piece in, I don’t know if I necessarily want to make a joke of it. I would love to help people get the information they need to live better, healthier lives.

You seem to have an affinity for former wrestlers – retweet when they received their boosters and such.

We want people to go out and get vaccinated if they’re eligible and get boosted if they’re eligible. And so sometimes we engage with celebrities or even amplify celebrities.

We did something with Lawless Lucy. I engaged with Conan O’Brien at some point last year when he was talking about the milk crate challenge. Marc Hamil, Mr T. And if someone sees a tweet from Mr. T, and they get their callback and say, Hey, maybe I want to do this, that’s great.

PFIZER AND BIONTECH OFFICIALLY REQUEST FDA TO AUTHORIZE 3-DOSE VACCINE FOR CHILDREN Wednesday, Pfizer and BioNTech completed their submission to the FDA for their three-dose Covid-19 vaccine for children 6 months to 4 years old. The submission was based on data from a Phase II/III clinical trial, in which 1,678 children received three doses of the companies’ mRNA vaccine at one-tenth the size of the adult dose. Immunized children developed comparable protection to young adults who received two full doses, and preliminary analysis suggests the vaccine reduced symptomatic Covid-19 infections by around 80%.

HHS: STILL UNDECIDED ON SHARING OF MONKEYPOX PHOTOSThe United States has not decided whether it will heed the World Health Organization’s call to share monkeypox vaccines as the number of cases increases around the world, reports Daniel Payne of POLITICO. “It is premature to comment on what actions related to this prior commitment could be taken in the current situation,” an HHS official said, referring to a 20-year-old vaccine-sharing agreement intended for a smallpox emergency. .

PLAINTIFFS DROP LAWSUIT AGAINST FDA OVER CIG MENTHOL REGULATION – Action on Smoking and Health, the African-American Tobacco Control Leadership Council, the American Medical Association and the National Medical Association on Wednesday formally dismissed their lawsuit against the FDA for failing to take action against menthol cigarettes. The fact that the agency had begun the process of drafting rules to ban these products was enough to dismiss the lawsuit – although the groups could revive the lawsuit if the agency delays action on menthol cigarettes in the future .

COLORADO APPROVES KRATOM REGULATIONSThis week, Democratic Gov. Jared Polis has signed into law a measure to regulate kratom, a herbal supplement that some are touting as an alternative to opioids, within state lines. The lawwhich mirrors recent efforts in other states, comes into effect in July 2023 and sets minimum requirements for kratom products and limits their sale to persons 21 and older.

Stacey Ma, Executive Vice President and Head of Technical Operations at Sana Biotechnology, will join Gilead Sciences as executive vice president of pharmaceutical development and manufacturing later this month.

CLARIFICATION: This newsletter has been updated to reflect that on June 3, after the Prescription Pulse deadline, the FDA extended its deadline for reviewing the ALS drug Amylyx until September 29 to allow time to review additional test data.

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