Insights^

E&C Leaders Release FDA User Fee Package

On Wednesday, bipartisan leaders of the House Energy and Commerce Committee released a legislative proposal to reauthorize the Food and Drug Administration’s (FDA) ability to collect fees from drug, biosimilar, and device manufacturers for five years.  Additionally, the bill contains several policy riders that would give the FDA more control over the accelerated approval program, promote diversity in clinical trials, and reinstate a ban on electric shock devices for aggressive behavior, among other items.  The Health Subcommittee is expected to markup the user fee bill next Wednesday, with the goal passing the legislation in Congress by August.

FDA Approves Marketing of New Alzheimer’s Test

The FDA on Wednesday approved the marketing of an in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.  Produced by Fujirebio Diagnostics, the test works by measuring the ratio of certain proteins in the fluid that surrounds the brain.  In a press release, the FDA said the availability of an in vitro diagnostic test could eliminate the needs for PET scans, which are time-consuming and expensive.  In a clinical study, the test detected Alzheimer’s disease in 97% of people who had amyloid plaques present in a PET scan.  The National Institute of Health (NIH) estimates that over six million Americans may have Alzheimer’s disease.

Survey: Most Parents Will Wait to Get Young Kids Vaccinated

18% of parents of children under 5 say they’ll get their kids vaccinated for COVID-19 as soon as a shot is authorized, according to a survey from the Kaiser Family Foundation.  Another 38% say they’ll take a “wait and see” approach before getting their kids vaccinated, while 56% want more information about vaccine safety and efficacy before making a decision.  Delays in FDA authorization of vaccines for young kids also left parents with mix feelings, with 22% saying the delays have made them more confident in the vaccine and 13% sayings the delays have made them less confident.  The survey was conducted in mid-April 2022, right before Moderna filed to authorize its vaccine for kids under 5 with the FDA.

Rent-A-Cops Arrive on Capitol Hill to Provide Security

To help address staffing shortages, the US Capitol Police (USCP) recently started deploying private security guards around the US Capitol Complex.  The private officers will wear grey dress pants and a navy-blue blazer rather than the police uniform and will be unarmed.  According to the USCP, the private officers will be stationed inside secure building like the House and Senate office buildings and will help augment existing patrols.

ICYMI: Jazz in the Garden Returns to National Mall on May 20

In two weeks, Jazz in the Garden will return to the National Gallery of Art Sculpture Garden along the National Mall.  The free concert series is a favorite summer tradition in Washington, DC, and this year’s series is set to features several genres including jazz, Afro-Brazilian, and bluegrass.  The series was closed during summer 2020 and was only open on a limited basis for summer 2021.  Guests will be required to register for the concert in advance.

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy.

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference.

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline.

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time.

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.