Source: Children’s Health Defense

New Hampshire House Votes Down Anti-Vaccine Bill

New Hampshire Bulletin reported:

The New Hampshire House of Representatives rejected a proposal Thursday to end all vaccine mandates in the state. “New Hampshire has the lowest vaccination rate for measles in New England,” Rep. Jessica LaMontagne, a Dover Democrat, said in a floor speech before the vote. “Do you want to be the legislature that ushers in the next outbreak of measles?”

Lawmakers voted, 192-155, to kill House Bill 1811, which was sponsored by Manchester Republican Rep. Matt Drew. Thirty-four Republicans joined Democrats to oppose the bill. In an effort to reach a compromise, Drew proposed an amendment that would keep only the polio vaccine required. However, the House rejected that amendment, and voted just on the original text.

New Hampshire state law requires children be immunized against hepatitis B, poliomyelitis (commonly known as polio), diphtheria, mumps, pertussis, rubella, rubeola, tetanus, varicella, and haemophilus influenzae type B. Children cannot legally enroll in school or child care until they’re vaccinated. The law grants exemptions to children whose doctor attests that such a vaccine would be detrimental to their health, as well as families with religious objections.

FDA’s Reversal on Moderna Flu Shot Bid Followed White House Pressure

Politico reported:

The FDA’s decision this week to reverse course and review Moderna’s seasonal flu vaccine application followed a meeting in which President Donald Trump expressed frustration to Commissioner Marty Makary over the agency’s handling of vaccine issues, according to two people familiar with details of the meeting.

Makary was called to the White House Thursday, two days after the company disclosed the agency’s letter refusing to accept the application, said the people, who were granted anonymity to discuss the matter.

The so-called Type A meeting that followed between Moderna and FDA officials — which companies can request after regulators refuse to accept an application as-is — was scheduled more quickly than is typical and “gave them a public way to save face,” one of the people said of the agency.

Upcoming Meeting of Federal Vaccine Panel May Be Postponed After HHS Missed Deadlines

STAT News reported:

Federal officials have missed the legal deadline to notify the public of an upcoming meeting of a vaccine advisory panel that was planned for next week, raising questions about whether the meeting, expected to be closely monitored for signs of the Trump administration’s intents, will be postponed.

Under federal law, agencies are required to announce advisory committee meetings, including those of the Advisory Committee on Immunization Practices, by certain periods ahead of time to allow for public input. A Federal Register notice puts that deadline at seven calendar days prior to the panel’s gathering, but a federal rule last updated in 2001 says the notice must be posted at least 15 days prior.

As of Wednesday, no notice had been posted by the Department of Health and Human Services, meaning the agency has missed both deadlines. STAT has asked HHS if the meeting, one of three regularly scheduled ACIP meetings held annually, will take place, but has not yet received a reply.

FDA Chief Marty Makary Says ‘Everything Should Be Over the Counter’ Unless Drug Is Unsafe or Addictive

CNBC reported:

Food and Drug Administration Commissioner Marty Makary told CNBC that he believes “everything should be over the counter” unless a drug is unsafe, addictive or requires monitoring — doubling down on a push that some in the pharmaceutical industry have questioned.

In an interview Wednesday in Washington, D.C., Makary said the FDA aims to make changes this year that allow more companies to offer their prescription medicines over the counter, or OTC. He noted that the agency is going through “the proper regulatory processes” to update OTC monographs —  the rulebooks that determine which drugs can be sold without a prescription. Makary said the FDA is looking at “basic, safe” prescription drugs like nausea medications and vaginal estrogen, which is used to treat menopausal symptoms like dryness and pain.

“In my opinion, everything should be over the counter and not requiring a prescription, unless it’s unsafe, unless you need laboratory tests to monitor how it’s being received by your body, or if it could be used for some nefarious purpose or it’s addictive,” Makary told CNBC after the PhRMA Forum, a one-day event organized by the pharmaceutical industry’s largest lobbying group.

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access

AP News reported:

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.

Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday. The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”