The directive includes brands from more than 20 companies such as Elf Bar, Esco Bar and Eon Smoke.

U.S. Senate Majority Leader Chuck Schumer said the companies do not have marketing authorizations and are therefore illegal. The FDA has now placed these products on the “Red List,” which means that CBP can detain shipments without inspecting them.

A 2022 federal survey by the FDA and CDC found that of the 2.6 million youth who regularly use e-cigarettes, more than half of them use disposable products. In March, these three companies sold more than 215 million units across the U.S., accounting for 12 percent of the e-cigarette market – Elf Bar made up the majority of these sales.

Two U.S. Food and Drug Administration advisory panels said the benefits outweigh the risks. They agreed that people would use the medication known as Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

Governor Kathy Hochul signs abortion rights package (June 13, 2022)

Governor Kathy Hochul has announced that the State will stockpile an abortion medication as part of ongoing efforts to protect access to abortion.

At the Governor’s direction, the New York State Department of Health will immediately begin purchasing Misoprostol in order to stockpile 150,000 doses, a five-year supply, in order to meet anticipated needs.

A federal judge in Texas ruled on April 7 to reverse the U.S. Food and Drug Administration‘s approval of mifepristone, an oral medication typically taken with misoprostol to end a pregnancy.

Conservative Christian legal advocacy group, Alliance Defending Freedom, requested the reversal in a lawsuit that said mifepristone is unsafe and that the FDA didn’t study it closely enough before approving its use. The FDA and mainstream medical doctors insist this isn’t true, and that there have been no safety concerns during the 23 years the drug has been on the market.
An injunction by the federal judge to ban mifepristone starting April 14 may impact as many as 64 million women of childbearing age in the U.S.

Hocul issued a statement saying, “Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception. New York will always be a safe harbor for abortion care, and I am taking action to protect abortion access in our State and continue to lead the nation in defending the right to reproductive autonomy.”

Hochul also announced that if the abortion medication Mifepristone is taken off the market, the State will commit up to an additional $20 million to providers to support access to other methods of care.

To further safeguard access to abortion medication, Hochul is also currently working with the State Legislature on new legislation to require private insurers to cover Misoprostol when it’s prescribed off-label for abortion and to ensure that no provider is charged increased medical malpractice coverage rates or loses coverage due to prescribing Misoprostol off-label.

Narcan

The U.S. Food and Drug Administration has approved selling naloxone over the counter.

The drug would be the first opioid treatment drug to be sold without a prescription.

In New York State, residents can already obtain Narcan from a pharmacy without a prescription thanks to a standing prescription order from the State Department of Health.

The drug can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.

The FDA sees making naloxone available more widely as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year

Emergent BioSolutions, the company that makes Narcan, said they expect the drug will become available over-the-counter by late summer. Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.

Several manufacturers of generic naloxone that’s made similarly to Narcan will now be required to file applications to switch their drugs over the counter as part of a requirement by the FDA.

WRFA’s Julia Ciesla-Hanley speaks with Mental Health Association Executive Director Steven Cobb about the FDA possibly approving naloxone to be offered over the counter.

Narcan

The FDA is considering making naloxone available over the counter in the United States.

Naloxone is a life-saving medication that can reverse an overdose from opioids, including heroin, fentanyl, and prescription opioid medications,, when given in time.

The panel of Food and Drug Administration experts voted unanimously last week in favor of the switch after a full day of presentations and discussions centered on whether untrained users would be able to safely and effectively use the nasal spray in emergency situations.

According to the National Institute on Drug Abuse, over 106,000 people died of opioid-related overdoses in 2021.

Mental Health Association in Chautauqua County Executive Director Steven Cobb is enthused about the news and said it will help remove stigma, “When you make something over the counter, I think it shows to a broader bunch of people that it’s safe to use and that people can handle using it. And it also makes Naloxone, or Narcan, which is a brand name, just available to a larger segment of the population.”

Cobb said people in New York can already obtain Narcan from a pharmacy without a prescription thanks to a standing prescription order from the State Department of Health, “New York State will cover the co-pay for your insurance, whether it’s private pay insurance or whether it’s Medicaid or Medicare. The pharmacist will put it through on your prescription and then New York State will cover the co-pay for three boxes of Narcan per year per New York State resident.”

Cobb said if the FDA approval goes through, he’d like to see Narcan made available through vending machines anywhere people who use substances gather, including health facilities, libraries, bars, and more.

He stressed that Narcan is not a drug that can be abused, “Unless you have opiates in your system, Narcan will have no effect on you. And there’s no ability to get high. You can’t be poisoned by Narcan. It’s a very safe drug to use for the community, to feel comfortable using, safety-wise there are no issues.”

A vote on the matter by the FDA is expected by the end of March.

For more information about Naloxone and training on how to use it, contact the MHA at 716-661-9044 or visit mhachautauqua.org

Bivalent COVID-19 Vaccine Booster

The Centers for Disease Control and Prevention has recommended the new omicron boosters for kids as young as age 5.

CDC Director Dr. Rochelle Walensky signed off on the shots Wednesday, just hours after the Food and Drug Administration authorized them. Walensky made the swift decision without a meeting of the CDC’s independent panel of vaccine experts.

Children ages 5 to 11 are eligible for Pfizer’s omicron shots and kids ages 6 through 17 are eligible for Moderna’s shots two months after receiving their primary series or previous booster with the first generation vaccines.

Pharmacies can start administering the shots as soon they have doses. According to a company statement, Pfizer said it will ship to up 6 million booster doses for kids within the next week.

Pfizer’s new boosters were cleared for people ages 12 and up in September, while Moderna’s were authorized for adults ages 18 and older.

The FDA hopes the new boosters, which target the dominant omicron BA.5 subvariant, will provide substantially better protection against infection and disease compared to the first generation of Covid shots.

The FDA authorized the BA.5 shots for kids without direct human data on their effectiveness. The agency cleared the boosters based on adult data from a similar shot that targets the omicron BA.1 subvariant.

The agency also looked at clinical studies in kids who received the original vaccines as boosters.

The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China, in 2019. The FDA hopes the shots will provide durable protection even as the virus continues to evolve because they cover a broad range of mutations.

The first generation of Covid shots were developed in 2020 to target the original strain of Covid. They are no longer providing meaningful protection against infection and mild illness because they do not match the dominant omicron variant, which has mutated to evade the antibodies that block the virus from invading human cells.

According to CDC data, more than 11 million Americans ages 12 and older have received the new booster shots so far.

Bivalent COVID-19 Vaccine Booster

The new bivalent COVID-19 vaccine booster is now available in Chautauqua County.

Chautauqua County Public Health Director Christine Schuyler issued a statement saying booster doses are common for many vaccines and that updated formulations are sometimes needed to provide the best protection against new variants of a virus.

The updated bivalent COVID-19 vaccine booster approved by the U.S. Food and Drug Administration and recommended by the CDC is designed to protect against original strains of the virus, which the former monovalent vaccines covered, and the Omicron variants that account for the majority of current new infections.

Schuyler said those who are eligible should get a new booster dose at least two months after completing their primary series or at least two months after receiving a booster. Pfizer’s updated booster dose is recommended for individuals 12 and older and Moderna’s updated booster dose is recommended for adults 18 and older.

The link for pharmacies offering the booster dose is available here:
https://chqgov.com/public-health/novel-coronavirus-covid-19

The Health Department is also offering bivalent Pfizer COVID-19 vaccine to individuals ages 12 and older at the Health Department Office in Mayville, Monday through Friday from 9 a.m. to 4 p.m. You are asked to call (716) 753-4491 to schedule an appointment.

The new shots target both the original strain of the coronavirus and the omicron BA.4/BA.5 subvariants that most people are catching now. This new vaccine is called a bivalent vaccine.

The Moderna COVID-19 vaccine is authorized for use as a single booster dose in people 18 and older.

The Pfizer-BioNTech booster is authorized for people 12 years and up. People are eligible for the new boosters two months after completing their initial vaccination or their last booster shot.

The federal government plans to make the boosters available starting next week. Public health officials hope they will help contain a possible fall and winter surge.

COVID-19 vaccines

The Food and Drug Administration‘s Advisory Committee approved amending the Emergency Use Authorization for the Moderna and Pfizer/BioNTech COVID-19 vaccine to expand to children ages six months through five years old. Next, the Food and Drug Administration will make a final decision on authorization of the vaccine, followed by recommendations made by the Centers for Disease Control and CDC Director, Dr. Rochelle Walensky.

Governor Kathy Hochul released a statement saying once the vaccine is recommended by the CDC Director, the State Department of Health will draft and issue guidance to providers.

Hochul said New York State is already making preparations to boost vaccination rates among children under the age of five with vaccine providers across the state already placing preliminary orders for 39,000 dosages. She added the State Department of Health is working to ensure providers across the state will be able to request additional doses, as well as developing a comprehensive statewide paid media campaign to encourage vaccinations that will launch this summer.