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— Senate schedules user fee bill markup for June 8, among a jam-packed month for your FDA reporters.
— FDA’s Twitter account balances memes with more serious tweets. The agency’s social media director tells us more about his 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 one heavily vaccinated dog after a vet trip this week.
Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).
SENATE HELP COMMITTEE TO MARK UP USER FEE BILL — The Senate HELP committee has officially scheduled a markup of the chamber’s bill to reauthorize FDA’s medical product user fees next Wednesday, June 8, beginning at 10 a.m. In addition to the user fee bill, the committee will mark up legislation aimed at improving access to mobile health care clinics.
June is shaping up to be an eventful month in the pharma world. Let your hosts break it down for you so you have a handy guide to the weeks ahead:
VRBPAC-palooza: FDA’s Vaccine and Related Biological Products Advisory Committee has four meetings on the docket, with the first happening Tuesday, June 7, as experts weigh whether to grant emergency use authorization to Novavax’s Covid-19 vaccine. We’ll dig into this more next issue.
June 14 and June 15 are pediatric vaccine days, with the first day focused on Moderna’s bid to vaccinate children ages 6 to 17 and the second covering Moderna’s and Pfizer’s applications to offer immunizations to children as young as 6 months. In a press briefing Thursday, White House Covid-19 Response Coordinator Ashish Jha said he expects the youngest children will be able to get their first vaccine doses starting June 21 at the earliest.
And on June 28, the FDA’s expert advisers will dig into the big question mark that’s hung over Covid vaccines — whether to sanction a change to the shots’ strain composition in time for a fall vaccination campaign.
Menthol cigarette ban listening sessions: In April, FDA issued long-awaited proposals to ban the sale of flavored cigars and menthol cigarettes. Menthol cigarettes are predominantly used by Black smokers and make up 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 menthol cigarette ban — even if targeted at manufacturers — would lead to an increase in policing of Black individuals and communities.
FDA has scheduled two listening sessions on June 13 and June 15 to hear concerns about the proposed rules.
Big pharma antitrust enforcement: The Federal Trade Commission announced it would be hosting a meeting spanning June 14 and June 15 to discuss how it plans to enforce antitrust laws within the pharmaceutical world.
ALS drug decision: 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 been trying to pressure the FDA and Congress to green-light the drug because of the dearth of treatments for the fatal disease, but the agency’s external advisory committee voted against approving the drug in March.
HOW FDA TWEETS BALANCE MEMES WITH SERIOUS BUSINESS — The FDA’s Twitter star has shone brightly throughout the pandemic, with the agency’s account veering from standard government press release fare to cheeky pop culture references. And how could anyone forget the regulator’s admonition that sentient social media consumers are not, in fact, horses?
Lauren chatted with FDA social media director Brad Kimberly about his content strategy, including his affinity for retweeting professional wrestlers. The conversation, a version of which appeared in POLITICO Nightly, is edited for space and clarity.
OK, so you are responsible for “you are not a horse”?
Yes. I did make those words happen.
Why did you decide to mix humor with the serious stuff? Did your approach change during the pandemic or have you been this meme-y all along?
The pandemic has given us an opportunity to talk a little more directly to people. In the past year, we’ve really focused on speaking in first person from 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’re pretty science-heavy; there’s a lot of complicated messages that we’re trying to get across, and not everybody out there has an M.D. or a Ph.D. So how can I communicate these complicated ideas to the masses? How can I get my mom to understand them?
Who is your target audience?
We want to bring some attention to a lot of issues — using humor to maybe poke a little fun at the use of veterinary-grade ivermectin in an effort to get people to maybe stop doing that. That is certainly not the way we would normally speak. But it made a huge difference.
Misinformation about ivermectin on social media really took a nosedive. I think people started seeing it as, OK, yeah, it’s kind of silly, eating horse paste. So it’s good to be able to have that kind of an effect, but then also getting that kind of awareness also gets people to come see our account, and so they’ll see not just the humorous stuff, but also the serious business.
How do you walk that line between using humor to convey important public health information and then not trying to sound glib?
When it comes to observances or internet holidays, I think we have a lot more latitude to kind of take that in a creative way — where I can say things on May the Fourth, Star Wars day, about “using the force is not a Covid prevention measure” as a way to tie into a trending topic, so that then people see it but also communicate the FDA message in a clever way. If there’s people [who] are affected by something that is happening in the world that we have a piece in, I don’t know that I necessarily want to make a joke out of that. I’d like to help people get the information they need to live healthier, better lives.
You seem to have an affinity for former wrestlers — retweeting when they’ve gotten their boosters and such.
We want people to go out and get vaccinated if they’re eligible and go get boosted if they’re eligible. And so sometimes we’ll engage with celebrities or even amplify celebrities.
We did something with Lucy Lawless. I engaged with Conan O’Brien at one point last year where he was talking about the milk crate challenge. Mark Hamill, Mr. T. And if somebody sees a tweet from Mr. T, and he’s getting his booster and says, Hey, maybe I want to do that, that’s great.
PFIZER, BIONTECH OFFICIALLY ASK FDA TO AUTHORIZE 3-DOSE VACCINE FOR KIDS — On Wednesday, Pfizer and BioNTech completed their FDA submission for their three-dose Covid-19 vaccine for kids 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 kids developed comparable protection to young adults who received two full doses, and a preliminary analysis suggests that the vaccine reduced symptomatic Covid-19 infections by about 80 percent.
HHS: STILL UNDECIDED ABOUT SHARING MONKEYPOX SHOTS — The U.S. hasn’t decided whether it will heed the World Health Organization’s call to share monkeypox vaccines as case numbers rise globally, POLITICO’s Daniel Payne reports. “It is premature to comment on what steps related to this previous commitment might 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 MENTHOL CIG REGULATION — Action on Smoking and Health, the African-American Tobacco Control Leadership Council, the American Medical Association and the National Medical Association officially dismissed their lawsuit against the FDA for failing to take action on menthol cigarettes on Wednesday. The fact that the agency began the rulemaking process to ban those products was enough to dismiss the suit — although the groups could revive the lawsuit if the agency delays action on menthol cigarettes in the future.
COLORADO APPROVES KRATOM REGULATION — This week, Democratic Gov. Jared Polis signed into law a measure to regulate kratom, an herbal supplement some tout as an opioid alternative, within the state’s borders. The law, which mirrors recently passed efforts in other states, goes into effect in July 2023 and sets minimum requirements for kratom products and limits their sale to those 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.
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