FDA launches program to speed up early-stage clinical trials

FDA on Monday announced the launch of a new initiative intended to accelerate early-stage clinical trials as the agency seeks to bring more clinical research back to the United States and counter China's growing dominance in drug trials.

The pilot program, part of a broader HHS initiative called "Operation Trailblazer," could reduce trial timelines by six to 12 months, according to FDA officials. The agency also issued guidance clarifying that one high-quality late-stage clinical trial with confirmatory evidence would be enough to support approval in many cases.

Currently, China conducts more clinical drug trials than the United States. Low costs, streamlined regulations, and government-provided subsidies have all made it more difficult for other countries to compete against China when it comes to clinical trials.

In an op-ed for Fox News, HHS Secretary Robert F. Kennedy Jr. said the United States is "losing ground" to China in clinical research and that FDA's actions can help reverse the trend.

"We are modernizing outdated processes that slow innovation and rebuilding the foundation for the next generation of medical breakthroughs," Kennedy wrote.

"We've been witness to a growing share of phase 1 clinical trials moving overseas, delaying opportunities for American patients and weakening the nation's position as a global leader in biomedical research," said acting FDA Commissioner Kyle Diamantas. "FDA is taking action to reverse that trend."

(Weixel, The Hill, 6/22; Cirruzzo/Lawrence, STAT+ [subscription required], 6/22)

CMS suggests insurers offer loans to customers who can't pay medical bills

In its Notice of Benefit and Payment Parameters for 2027 final rule issued last month, CMS suggested that health insurers consider offering loans to any customers who can't afford their out-of-pocket medical costs.

As part of this approach, any patient who develops a costly disease or needs unexpected emergency care would be able to request a loan from their health insurer to cover their part of the bill. However, that loan would need to be repaid and presumably with interest.

According to Trump administration officials, the idea could help people who chose a health plan with a low monthly premium and high out-of-pocket costs if they unexpectedly encounter an exceptionally expensive medical bill.

FTC sues medical group that advises on transgender medical treatments

The Federal Trade Commission (FTC) last week filed a lawsuit against the World Professional Association for Transgender Health (WPATH), a leading international group that writes guidelines on gender-related medical treatments, alleging the group used questionable evidence to make sure its services would be covered by health insurers and made false claims to parents to sell pediatric medical transition services. Four states, Alaska, Iowa, Nebraska, and Texas, also joined the lawsuit.

In the lawsuit, FTC claims WPATH failed to disclose side effects and misrepresented the medical necessity of gender-affirming care for minors. It also alleges that WPATH made these claims and deemed virtually all medical transition services as "medically necessary" to maximize the likelihood that insurers would pay for the procedures.

According to Joe Simonson, FTC's director of public affairs, the members of WPATH "have profited immensely from the organization's work, but this profit has come at the expense of children and their parents."

In a statement, WPATH said it expects the court to find the Trump administration is "acting out of pure retaliation. "

"The U.S. Federal Trade Commission is not a medical provider and has no place interfering with the process of individualized medical decision-making," the organization said. "The FTC also does not have any jurisdiction over WPATH and its noncommercial speech. The state claims have similar factual and legal flaws."

(Weixel, The Hill, 6/17; Harmon, et al., New York Times, 6/17)

RFK Jr. announces $700M investment into addiction services, emphasizing faith-based organizations

HHS Secretary Robert F. Kennedy Jr. last week announced a $700 million investment into behavioral health programs and emphasized the importance of faith-based recovery organizations.

The investment includes a $96 million funding opportunity for the Trump administration's Safety Through Recovery, Engagement, and Evidence-based Treatment and Support (STREETS) program, as well as $612 million in funding opportunities for other behavioral health programs.

"One of the features of our STREETS is opening up funding once again for faith-based organizations," Kennedy said at the Easterseals MORC treatment center in Michigan. "The Biden administration actively discouraged funding to faith-based organizations for recovery. We think they're critical."

In the speech, Kennedy blamed the Biden administration's focus on harm reduction tactics like needle exchange programs and safe injection sites for creating a "proliferation of open-air drug markets around the country."

"We know what doesn't work. Ignoring addiction doesn't work. Harm reduction doesn't work," Kennedy said.

According to a press release from HHS, the STREETS program will award eight communities $3 million a year for four years to support the development of "multisector, state-of-the-art care systems for people who are homeless and have substance use disorders, serious mental illness, or co-occurring disorders."

(Choi, The Hill, 6/17)