Overnight Health Care: CDC encourages schools to open for in-person learning, masks optional | President directs moves on drug importation, calls for plan to lower drug prices | FDA asks for federal investigation of Alzheimer’s drug approval

Welcome to Friday’s Overnight Health Care. Vaccination rates are so low in Mississippi, and the delta variant is spreading so quickly, the state health department is now recommending anyone over 65 avoid large indoor gatherings regardless of whether they’ve been vaccinated or not. 

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Today: The CDC updated its school guidance, and masks are optional. The Biden administration launched a drug pricing push as part of an executive order on competition, and the FDA is asking for a federal investigation into its own approval of a controversial Alzheimer’s drug. 

We’ll start with CDC:

CDC encourages schools to open for in-person learning

The Centers for Disease Control and Prevention (CDC) is encouraging schools to open for in-person learning this fall, and said that fully vaccinated students and teachers do not need to wear masks indoors.

The updated CDC guidance eases recommendations for kindergarten through 12th grade, and comes as coronavirus vaccines have become widely available for anyone over the age of 12.

The CDC noted that while COVID-19 outbreaks have occurred in school settings, multiple studies have shown that school transmission rates are typically lower than — or similar to — community transmission levels when multiple prevention strategies are in place.

No proof: But the agency is not recommending that vaccines be required for all eligible students and teachers, and it is also not recommending how administrators can distinguish between who has been vaccinated and who has not. The administration has, for better or for worse, avoided wading into thorny issues around vaccine mandates or passports. That lack of guidance is likely going to pose implementation problems.

Patchwork rules: The guidance comes as some schools or states have already made decisions about the next year, since the school year starts for some districts in about a month. Texas Gov. Greg Abbott (R) banned public schools from requiring masks, while California said it will continue to require masks in all K-12 schools for consistency’s sake.

Read more here.

 

Lots of health care moves to chew on in Biden’s new executive order: President directs moves on drug importation, calls for plan to lower drug prices

President Biden on Friday directed the Food and Drug Administration (FDA) to work with states on importing prescription drugs from Canada, and called on officials to develop a “comprehensive plan” to lower drug prices in 45 days.

The moves are part of the health care section of a wide-ranging executive order on promoting competition in the economy that Biden signed on Friday afternoon. 

Allowing imports of cheaper drugs from other countries was part of Biden’s health care plan during the campaign, but Friday’s move is a step toward action on that front. 

The Trump administration also put forth rules for states to apply to allow drug imports, and Florida in particular has expressed interest, but no imports have actually begun. Drugmakers have also filed a lawsuit to block the rules. 

Some mystery: The Biden administration also appears to be considering other actions to lower drug prices as part of the “comprehensive plan,” though it is not clear what steps those will be. 

Other actions

• Directs the Department of Health and Human Services to consider issuing rules within 120 days to allow hearing aids to be sold over the counter. 
• Directs the Federal Trade Commission and Department of Justice to revise their guidelines for hospital mergers to “ensure patients are not harmed by such mergers.”
• Encourages the FTC to ban “pay for delay” agreements, where a brand-name drug company pays a generic drug company to delay introducing competition to a certain drug.

Read more here. 

 

FDA asks for federal investigation of Alzheimer’s drug approval

The acting head of the Food and Drug Administration on Friday requested a federal investigation into her own agency’s controversial approval of an Alzheimer’s drug last month.

In a letter to the independent Office of Inspector General, acting FDA Commissioner Janet Woodcock asked the watchdog to investigate the interactions between representatives of Biogen and FDA during the process that led to the approval of the company’s Alzheimer’s drug Aduhelm.

“There continue to be concerns raised … regarding contacts between representatives from Biogen and FDA during the review process, including some that may have occurred outside of the formal correspondence process,” Woodcock wrote in the letter posted and dated Friday to acting Inspector General Christi Grimm. Woodcock said she has “tremendous confidence in the integrity of the staff and leadership” of the agency, and intends to fully cooperate with the OIG if a review is launched.

Backstory: FDA has been under fire since it first announced approval of Biogen’s drug late last month. Critics say there’s no clear evidence the drug will actually slow the cognitive decline of Alzheimer’s patients, which is what the drug is designed to do. There are also serious concerns over the $56,000 per patient price tag, and what it could do to the financial solvency of the Medicare program.

Read more here.

 

Bipartisan lawmakers press NIH for info on deleted coronavirus data

A bipartisan pair of lawmakers want information from the National Institutes of Health (NIH) about the deletion of data on the genetic sequence of the SARS-CoV-2 virus that could provide answers regarding the virus’s origin.

In a letter sent Friday and shared first with The Hill, Reps. Raja Krishnamoorthi (D-Ill.) and Mark Green (R-Tenn.) ask for answers about the missing genetic sequences, and press NIH Director Francis Collins to ensure there are safeguards in place to protect scientific data.

What data: The letter comes after a scientist last month said he found some of the genetic sequences of the virus that had previously been uploaded to an NIH server in March 2020 were subsequently deleted at the request of the Chinese researchers from Wuhan who initially uploaded them.

“Given that the true origin of SARS-CoV-2 remains a mystery, the NIH must fully account for the decision to delete information that could bring the world closer to a conclusion,” Green and Krishnamoorthi wrote.

NIH response: The NIH said the requestor wanted the data removed from the agency’s Sequence Read Archive and indicated it was being submitted to another database. Submitting investigators hold the rights to their data and can request withdrawal of the data, the agency said.

The NIH also said staff “can’t speculate on motive beyond a submitter’s stated intentions.”

Read more here. 

 

European Medicines Agency panel: mRNA COVID-19 vaccines possibly linked to ‘very rare’ heart inflammation cases

A committee of the European Medicines Agency (EMA) determined that the mRNA COVID-19 vaccines could possibly be linked to “very rare” cases of heart inflammation among vaccine recipients.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Union’s health body concluded in a Friday release that types of heart inflammation called myocarditis and pericarditis “can occur in very rare cases following vaccination” with the Pfizer-BioNTech and Moderna vaccines.

The heart inflammation conditions produce symptoms such as breathlessness, palpitations and chest pain. Those who experience these symptoms were instructed to seek immediate medical attention.

By the numbers: The EMA identified and analyzed 145 cases of myocarditis among Pfizer-BioNTech recipients and 19 among Moderna recipients. The committee looked into 138 pericarditis cases among patients who got Pfizer-BioNTech and another 19 for Moderna. 

These cases occurred out of 177 million Pfizer doses and 20 million Moderna doses in the European Economic Area, with the conditions occurring in 0.00016 percent and 0.00019 percent of Pfizer and Moderna vaccinations, respectively. 

Panel’s recommendation: The PRAC still recommended listing myocarditis and pericarditis as new side effects in the product information for both vaccines in order to ensure health professionals and patients know about the infrequent cases.

“EMA confirms that the benefits of all authorized COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications and as scientific evidence shows that they reduce deaths and hospitalizations due to COVID-19,” the release said. 

Read more here. 

 

What we’re reading

Pfizer suggests booster shots will be needed this year, but government officials say science will dictate the timing (The Washington Post)

Federal speech rulings may embolden health care workers to call out safety issues (Kaiser Health News)

Biogen Alzheimer’s drug will exceed the $56,000 list price for many, analysis says (The Wall Street Journal)

 

State by state

Washington schools won’t require masks outdoors, but state still reviewing new CDC guidance on indoor mask-wearing (The Seattle Times)

Delta variant on the rise in Indiana, state health officials say (Indianapolis Star)

Ohio law allows doctors to deny health care and birth control to LGBTQ patients (Fortune)