FDA to limit access to COVID-19 vaccines to people over the age of 65 and those who are high-risk

In a commentary published in the New England Journal of Medicine on Tuesday, FDA Commissioner Marty Makary and Vinay Prasad, director of the Center for Biologics Evaluation and Research, announced that FDA will limit future access to COVID-19 vaccines — only allowing people ages 65 and older and those who are at high risk of complications related to the disease to get updated shots going forward.

The framework does not apply to currently approved vaccines but would go into effect as manufacturers update their shots to target new COVID-19 strains.

FDA will also require manufacturers to conduct clinical trials to show whether COVID-19 vaccines are of benefit to healthy younger adults and children.

In the commentary, Makary and Prasad argued that the current recommendations that everyone ages 6 months and older receive a COVID-19 vaccine is out of step with the rest of the world and may be unnecessary given how many people have developed some form of immunity protection to the coronavirus through vaccinations, infections, or both.

Randomized, placebo-controlled trials of healthy adults will help determine if the COVID-19 vaccines are still beneficial to people who aren't at high risk of infection, Makary and Prasad wrote.

"These clinical trials will inform future directions for the FDA, but more important, they will provide information that is desperately craved by health care providers and the American people," they wrote.

Makary and Prasad also suggested that COVID-19 booster recommendations have contributed to declining trust in vaccines, including the measles-mumps-rubella (MMR) vaccine, which they described as "clearly established as safe and highly effective."

Makary and Prasad estimated that 100 million to 200 million Americans would qualify as high risk for severe COVID-19, including people with cancer, heart conditions, obesity, mental health diagnoses like depression, and pregnant people.

Anna Durbin, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, said the requirement for new studies on vaccines "that have already demonstrated reduction in symptomatic disease and are only being updated based on new strains is ill-advised. These studies are expensive and will take time. If vaccines are updated annually, then the results will not be ready in sufficient time for people to use the vaccines."

Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, said the announcement "basically neuters" the Advisory Committee on Immunization Practices (ACIP).

"It's terribly unfortunate that the FDA has decided that they will now be both [the Vaccines and Related Biological Products Advisory Committee] and ACIP," Osterholm said, adding that the approach of having FDA license vaccines but CDC and its expert panels decide who to recommend vaccines for has been "a wonderful check and balance on putting forward the best science."

(Branswell, et al., STAT+ [subscription required], 5/20; Prasad/Makary, New England Journal of Medicine, 5/20)

Trump administration shares additional details on plan to lower drug prices

HHS on Tuesday shared additional details outlining how it plans to push pharmaceutical companies to lower their drug prices in the United States and more closely align them with other nations.

HHS will aim to negotiate drug prices down to the lowest prices paid by other countries that are part of the Organization for Economic Cooperation and Development and have at least 60% of the GDP per capita of the United States. According to STAT, countries that appear to meet this GDP threshold include Germany, France, and the United Kingdom.

The pricing target will apply to brand-name drugs that don't face competition from generics or biosimilars, HHS said.

"For too long, Americans have been forced to pay exorbitant prices for the same drugs that are sold overseas for far less," said HHS Secretary Robert F. Kennedy Jr. "That ends today. We expect pharmaceutical manufacturers to fulfill their commitment to lower prices for American patients, or we will take action to ensure they do."

(HHS press release, 5/20; Payne, STAT+ [subscription required], 5/20)

CMS said in its proposed rule that it has found some loopholes in its statistical test and that some waivers have passed the test but aren't generally redistributive, especially taxes on Medicaid managed care organizations.

As a result, CMS proposed banning states from effectively taxing provider revenue from Medicaid at higher rates than Medicare or commercial healthcare, even if a state's proposal passes CMS' statistical test.

"States are gaming the system — creating complex tax schemes that shift their responsibility to invest in Medicaid and rob federal taxpayers," said CMS Administrator Mehmet Oz in a news release.

"While we are still reviewing the proposal, any effort to reduce provider taxes would harm long-term care facilities and hospitals' ability to care for Medicaid patients," said Marie Johnson, senior director of media relations for the Catholic Health Association of the United States. "These taxes are essential to keeping state Medicaid programs afloat and enabling hospitals to continue providing critical health care services to their communities."

(Early, Modern Healthcare, 5/12)

FDA aims to remove ingestible prescription fluoride products for children from the market

FDA last week announced it plans to take ingestible prescription fluoride products for children off the market, citing concerns that fluoride alters the gut microbiome of children.

In a release, FDA said that ingestible fluoride products differ from goods like toothpaste and mouthwash because they have been "shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood."

FDA set an Oct. 31 deadline for completing a safety review and public comment period for removing ingestible fluoride products.

Fluoride tablets and lozenges are sometimes recommended for children and teens who are at an increased risk of either tooth decay or cavities because of low fluoride in their local drinking water.

"The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child's microbiome," said FDA Commissioner Marty Makary.

"Ending the use of ingestible fluoride is long overdue," said HHS Secretary Robert F. Kennedy Jr. in a statement. "This decision brings us one step closer to delivering on President Trump's promise to Make America Healthy Again."

"Proposals like this stand to hurt rural America, not make them healthier," said American Dental Association President Brett Kessler. "More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation."

Kessler added that FDA's plan "will be particularly harmful to the most vulnerable and those who lack access to care."

(Choi, The Hill, 5/13; Perrone, Associated Press, 5/13)

HHS unveils autism patient database project

Earlier this month, HHS said that NIH and CMS will build a data platform to conduct research across EHR data and consumer wearables to focus on "enabling research around the root causes" of autism. Researchers will be able to use the platform to identify autism diagnosis trends, health outcomes from interventions, and access to care by demographics, geography, and economic burdens.

CMS and NIH will specifically focus on Medicare and Medicaid enrollees with a diagnosis of autism and will establish "a secure tech-enabled mechanism to enhance this data sharing with timely, privacy, and security compliant data exchange," HHS said.

"We're using this partnership to uncover the root causes of autism and other chronic diseases," said HHS Secretary Robert F. Kennedy Jr. "We're pulling back the curtain — with full transparency and accountability — to deliver the honest answers families have waited far too long to hear."

David Mandell, a professor of psychiatry and autism researcher at the University of Pennsylvania, said that HHS' announcement is "the registry without the word 'registry' in it" and expressed concern that the data would be "misused or misappropriated" or steered towards vaccine studies.

"We are creating a tool, and tools can be used for good and for evil," Mandell said. "I know a lot of researchers — and I like to think of myself as one — who have used this kind of tool for good. And I'm really concerned that that's not what happens."

(George, MedPage Today, 5/7; Stolberg, New York Times, 5/7)