House greenlights psychedelic research in NDAA, drug shortage and PBM reforms to come

The House of Representatives passed its wide-reaching defense spending bill Friday on a largely party-line vote, greenlighting a bipartisan provision that would direct the Department of Defense to carry out studies on the use of psychedelics to treat service members with conditions like post-traumatic stress disorder.

With about two weeks until August recess, Congress’ pharma-related to-do list of PBM and drug shortage reforms, as well as pandemic preparedness, will likely wait for the fall.

The House’s 1200-page National Defense Authorization Act, which passed by a vote of 219 to 210, includes a provision that would kickstart a study on psychedelics to treat conditions including PTSD and brain injuries in service members being treated at military treatment facilities. The provision is spearheaded by Reps. Dan Crenshaw (R-TX), Alexandria Ocasio-Cortez (D-NY) and Lou Correa (D-CA), who say psychedelic research is critical to determining how those drugs could help treat conditions like post-traumatic stress disorder and depression.

Psychedelics are currently classified as a Schedule 1 drug, meaning they’re deemed to have high potential for abuse, which makes it difficult for scientists to carry out studies on them.

The legislation comes as FDA is also turning its attention to psychedelics. The agency last month published draft guidance on clinical trials for psychedelic drugs, including compounds like psilocybin and LSD as well as drugs like MDMA.

Dan Crenshaw

Crenshaw said at a press conference Thursday that there are still some details from the original bill that didn’t make it into the NDAA version, but he’s hopeful that they can make it into the final bill that will get signed into law.

“I still have some concerns that what’s currently in there does not fund what we want it to fund at the DoD, nor does it exactly specify that these need to be clinical trials just like our original bill that we worked on did,” he said.

Up next for the NDAA, the Senate will take up its own version of the bill before both chambers must reconcile the differences ahead of hitting President Joe Biden’s desk.

As Congress gears up for its month-long August recess, legislators’ to-do list still includes continuing work on reauthorizing a key pandemic preparedness bill and taking up legislation that would reform pharmacy benefit managers, or PBMs.

Pandemic preparedness

Congress is currently working on reauthorizing the Pandemic and All-Hazards Preparedness Act, a must-pass piece of legislation that will expire this fall if not reauthorized. Democrats want to use the reauthorization as an opportunity to give FDA more authority to address drug shortages, but Republicans don’t think PAHPA reauthorization is the right pathway to do that.

Among the authorities FDA has asked for includes requiring drug companies to report increases in demand for drugs, which is what drove several shortages of key cancer drugs and amoxicillin in recent months.

Instead of including this in PAHPA reauthorization, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) announced plans earlier this week to release a discussion draft of separate legislation that would address drug shortages. Rodgers, alongside Senate Finance Committee Ranking Member Mike Crapo (R-ID), put out a request for information on the topic last month.

“The problem demands more attention than rushing a few broad FDA bills through committee,” Rodgers said at an Energy and Commerce health subcommittee markup of a slate of health bills Thursday.

But Democrats are still frustrated. Energy and Commerce committee member Frank Pallone (D-NJ) said at the markup that he views his Republican colleagues’ refusal to address this in PAHPA as indicative of a party-wide distrust in federal agencies.

“I’m concerned that this extreme right wing attitude towards saying that the agencies don’t know what they’re doing, let’s not give them additional authorities even if they ask for it, is now permeating this committee,” Pallone said.

PBM reform

The Senate Finance Committee on July 26 is slated to mark up bills to help put an end to dubious practices by pharmacy benefit managers or PBMs.

The Finance committee’s work follows the PBM-related reforms that advanced out of the Senate Health, Education, Labor and Pensions Committee in May. The Senate’s legislation would prohibit spread pricing, which is where PBMs from charging health plans more for a drug than what the PBM reimburses to the pharmacy.

A bipartisan group of senators last month also introduced the Patients Before Middlemen Act, which seeks to delink what PBMs get paid from the price of a drug.

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