HEALTH CARE BRIEFING: Medical Mushroom Hunt Finds Hurdles in DEA

Erinn Baldeschwiler, who is battling metastatic breast cancer, is one of two terminally ill patients seeking access to psilocybin under Right to Try, a federal law and an array of state laws meant to grant people facing death access to experimental drugs outside of a clinical trial.

Her case is being closely watched by supporters of Right to Try and the research community because it has long-reaching implications for end-of-life care and the role of the Drug Enforcement Administration. The case also showcases the difficulties people face in managing care in their final years, when some seek as normal a life as possible.

Baldeschwiler and her allies have support from both left-leaning and libertarian groups, as well as lawmakers on both sides of the aisle—all pushing to give people more control over their care at the end of their lives. “There’s a fundamental question being asked here about DEA’s authority and Right to Try,” said Jayashree Mitra, a former neuropharmaceutical researcher at Yale University who now is an attorney in the cannabis and psychedelics field. “Does Right to Try apply to anything the patient needs without judgment, or is there some requirement that the product you’re seeking is going to alleviate your condition?”

In January, a bipartisan group that included Reps. Earl Blumenauer (D-Ore.) and Andy Biggs (R-Ariz.) wrote to the DEA with concerns the agency was “obstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.” An aide for Biggs said the DEA didn’t respond to their office.

Baldeschwiler earlier this month took her effort to Washington, D.C., where she and others protested in front of the DEA’s headquarters and met with the staff of her home-state senator, Patty Murray (D-Wash.), chair of the Health, Education, Labor, and Pensions Committee. Read more from Alex Ruoff.

Formula Makers Tell Biden They Foresaw Dire Shortages

President Joe Biden defended his administration’s response to a national baby formula shortage, saying he acted as soon as he became aware of the crisis in April, even as manufacturers told him Wednesday they saw it coming months earlier as soon as Abbott Laboratories issued a key recall. “We knew from the very beginning that this would be a very serious event,” Robert Cleveland, senior vice president for North America and Europe nutrition for Reckitt Benckiser, told Biden at a White House meeting.

Biden and the FDA have drawn criticism from lawmakers in both parties for the government’s slow response to the shortage, which began with supply-chain turmoil caused by the pandemic but worsened after Abbott recalled formula in February and shut down a Michigan factory over contamination fears.

Biden has said the government may have responded more quickly “if we’d been better mind readers.” After a reporter pointed out that the formula executives had just told him they foresaw the impact of the shutdown, he responded: “They did. I didn’t.” Read more from Justin Sink, Martine Paris, Josh Wingrove, and Nancy Cook.

What Else to Know Today

Pfizer Submits Covid Shot for Kids Under 5 for FDA Clearance: Pfizer asked U.S. regulators to clear its Covid-19 vaccine for emergency use in children under age 5, an effort to extend protection against the virus to the country’s youngest. The drugmaker and BioNTech SE finalized their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through 4 years old, the companies said in a statement on Wednesday. Read more from Riley Griffin.

Firms Offer Free Defense for Abortion Seekers, Providers: Over 20 law firms and the San Francisco City Attorney’s office pledged to provide free legal representation to people seeking abortions and those providing the services if the US Supreme Court overturns Roe v. Wade. Read more from Joyce E. Cutler.

• In Texas, a state lawmaker and private citizens told a federal court that a group funding abortion services must be barred from proceeding with a suit to block the enforcement of a criminal abortion law and a law that bans abortions after six weeks. The Stigma Relief Fund and donors to abortion funds lack standing to sue state representative Briscoe Cain III (R) and a trio of women they identified as likely to bring suits against them under S.B. 8, the defendants told the District Court for the Western District of Texas. Read more from Mary Anne Pazanowski.
• In Florida, a new law forbidding abortions after a person has been pregnant for 15 weeks violates the state’s constitution, health clinics that perform abortions say in a suit filed on Wednesday. The law, known as HB 5, is scheduled to go into effect July 1. HB 5 violates the state constitution’s right to privacy—a provision the state’s top court has held embodies a person’s decision on whether to end a pregnancy, the complaint filed in the Florida Circuit Court, Leon County, says, Pazanowski reports.

LGBTQ Advocates Want to Resume ACA Bias Rule Fight: LGBTQ advocacy groups are seeking to reopen a case by July 31 against a Trump-era rewrite of an Obamacare anti-discrimination rule if the Biden administration doesn’t propose a new rule by that date. The suit stems from the Trump-era removal of gender identity and sexual orientation from a list of anti-discrimination protections under Section 1557 of the Affordable Care Act in 2020. The case was put on hold in the US District Court for the District of Columbia in 2021 after Biden was inaugurated. Read more from Allie Reed.

More Headlines:

• CNN Gets Texas Doctor Defamation Case Over Covid Care Moved
• Marc Schessel Indicted for Securities Fraud Over Covid Tests: DOJ
• Sage Rises After Postpartum Depresssion Trial Meets Main Goals
• Ingenus, Leiutis Sue Nexus to Block Copies of Cancer Treatment

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editor responsible for this story: Michaela Ross at mross@bgov.com