HHS revives long-dormant childhood vaccine safety panel

HHS has announced that it will revive the Task Force on Safer Childhood Vaccines "to improve the safety, quality, and oversight of vaccines administered to American children." The task force was originally created in 1986 and later disbanded in 1998.

NIH Director Jay Bhattacharya will chair the taskforce while CDC Director Susan Monarez and FDA Commissioner Marty Makary will be members. Additional task force members will be announced in the future, according to HHS spokesperson Andrew Nixon.

The new task force will work closely with the Advisory Commission on Childhood Vaccines, and both groups will provide advice on how to improve reporting for adverse vaccine reactions and work to create childhood vaccines that cause fewer and less serious adverse reactions.

According to the Washington Post, many anti-vaccine activists have pushed for the task force to be revived. In May, Children's Health Defense, an anti-vaccine group founded by HHS Secretary Robert F. Kennedy Jr., sued Kennedy to push him to reestablish the task force and submit reports to Congress every two years.

"It's a great day for people who want safe vaccines and know that there are people that care in the government now finally looking at it," Del Bigtree, head of the anti-vaccine organization Informed Consent Action and the former communications director for Kennedy's presidential campaign.

So far, several health experts have expressed concerns about the decision.

"I am concerned that bringing this committee back implies to the public that we have not been looking at vaccine safety," said David Higgins, a pediatrician and preventive medicine specialist at the University of Colorado Anschutz Medical Campus. "The reality is, we evaluate the safety of vaccines more than any other medication, medical intervention, or supplements available."

"What's the point now, other than he'll use it as a bully pulpit to push his MAHA, anti-vaccine agenda? That's the worry," said Peter Hotez, co-director of the Texas Children's Hospital Center for Vaccine Development.

"Who's he going to put on this committee?” Hotez added. "Will it be like [the Advisory Committee on Immunization Practices], where he starts to stack it with anti-vaccine activists?"

(Roubein/Sun, Washington Post, 8/14; Bendix, NBC News, 8/15)

Trump rescinds Biden-era executive order on healthcare competition

Last week, President Donald Trump rescinded an executive order issued under the Biden administration that aimed to increase competition in the U.S. economy, including healthcare.

The order, which was signed in July 2021, directed federal agencies to take a more aggressive stance against consolidation across different industries. This led to increased scrutiny of healthcare mergers and acquisitions, heighted oversight of hospital consolidation, and new rules aimed at reducing anticompetitive practices by payers and providers.

In the order revoking Biden's directive, Trump cited a need to decrease regulatory burdens and allow markets to function more freely.

According to Federal Trade Commission chair Andrew Ferguson, the repeal of the Biden executive order removes "top-down competition regulations" that were hostile to mergers and acquisition. Going forward, Ferguson said the Trump administration will focus on enforcing existing antitrust laws.

The Department of Justice's antitrust division was also supportive of Trump's decision, with Assistant Attorney General Abigail Slater saying that the rule allows regulators to recalibrate federal competition policy and focus on "empowering the American people in free markets" instead of prescribing outcomes.

However, Sen. Amy Klobuchar (D-M.N.), ranking member of the Senate Judiciary Subcommittee on Privacy, Technology and the Law, said the decision was harmful to consumers.

"President Trump's decision is a step backward for consumers, entrepreneurs, workers, and family farmers," Klobuchar said. "It will lead to higher prices, fewer choices, and less innovation. The Department of Justice and the Federal Trade Commission must vigorously enforce the antitrust laws, including by continuing to move forward cases brought under the last Administration."

(Condon, Becker's Hospital Review, 8/18; Lagasse, Healthcare Finance, 8/18)

Federal judge blocks exemptions to ACA birth control mandate

Under the Affordable Care Act (ACA), employer health plans are required to cover at least one of 18 forms of birth control that have been approved by FDA. However, religious groups and employers sued, and in 2014, the U.S. Supreme Court ruled 5-4 that the birth control mandate violated the Religious Freedom Restoration Act (RFRA) for owners of closely held corporations who had religious objections.

Although federal agencies have tried to balance ACA's birth control mandate with the RFRA, the Trump administration issued a blanket exemption in 2017. In response, dozens of states, including Pennsylvania and New Jersey, sued to stop the broad expansion of exemptions and accommodations to the mandate.

Trump orders critical drug ingredients to be stockpiled

In a new executive order, President Donald Trump directed HHS' Administration for Strategic Preparedness and Response (ASPR) to identify and stockpile active pharmaceutical ingredients (API) of drugs that are deemed critical for national health and security.

According to Axios, the order continues efforts started by the Biden administration to shore up the U.S. medical supply chain and reduce reliance on overseas manufacturers. So far, the federal government has directed millions of dollars toward developing domestic sources of key ingredients for asthma, diabetes, and anxiety treatments.

Under the executive order, ASPR has 30 days to create a list of around 26 drugs that are "especially critical to the health and security interests of the nation." The agency has also been tasked with determining how to use existing funds to obtain and maintain a six-month supply of the chosen APIs for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR). According to Fierce Pharma, SAPIR was formed during Trump's first administration.

ASPR has also been instructed to prioritize sourcing APIs from U.S. manufacturers when possible. "Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make," the executive order said. "Filling the SAPIR will also insulate the United States from the concentration of foreign, sometimes adversary, nations in the world-wide supply of the key starting materials used to make APIs."

(Kansteiner, Fierce Pharma, 8/14; Bettelheim, Axios, 8/14)

Drugmakers form new lobbying group to target Medicare drug price negotiations

A group of drugmakers have partnered to form a new lobbying group called the IRA Watchdog, which describes itself as a "coalition analyzing the impact of Medicare Drug Price Negotiation on patients." Members of the group include Merck, AstraZeneca, Bristol Myers Squibb, and Eli Lilly.

According to STAT, the group is named after the Inflation Reduction Act (IRA), which directed Medicare to negotiate the prices of certain drugs. Although many drugmakers have opposed Medicare drug price provisions, they have been supportive of other provisions in the law, including out-of-pocket spending caps for older adults.

The lobbying group is part of the firm DLA Piper, whose lobbyists are former staffers of former Sen. Richard Burr (R-N.C.). While in Congress, Burr championed the biotech sector and is a senior policy advisor at DLA Piper and chair of its health policy strategic consulting committee.

DLA Piper has published several papers on the impact of Medicare drug price negotiations, including on issues relating to the number of Medicare Part D and Medicare Advantage plans available for older adults, their premiums, and drug formularies. The firm has also researched increased copays for diabetes medications and a decline in access for some rare disease treatments, both of which it says are due to Medicare drug price negotiations.

(Wilkerson, STAT+ [subscription required], 8/13)