VETS UPSET OVER MDMA DECISION — Veterans groups are disappointed that the FDA rejected drugmaker Lykos Therapeutics' application for MDMA and talk therapy as a post-traumatic stress disorder treatment. “I am living proof that MDMA-Assisted Therapy is safe, effective, life-changing, and even life-saving. By not approving MDMA-AT, the FDA is risking the lives of the 13 million Americans suffering from PTSD,” Cristina Pearse, a participant in Lykos’ clinical trials, said Friday. What happened: The FDA told Lykos on Friday that the agency had reviewed the drugmaker's application, but could not approve Lykos' application based on the data the company had submitted to date, POLITICO’s Erin Schumaker reports. The FDA requested that Lykos conduct an additional Phase 3 clinical trial to further study MDMA's safety and efficacy, according to a Lykos press release. Lykos plans to ask for a meeting with the FDA in hopes the agency will reconsider its decision and to discuss the possibility of Lykos resubmitting. Why it matters: While psychedelics research will continue, including at the Department of Veterans Affairs and the National Institutes of Health, FDA approval would have cut red tape for psychedelics researchers and likely sped up their work. Veterans react: “This is the epitome of bureaucratic red tape — and the result is people will keep dying,” advocacy group Heroic Hearts Project and Healing Breakthrough said in a statement. The FDA’s decision comes days after a bipartisan group of lawmakers appealed to President Joe Biden and FDA Commissioner Robert Califf in letters signed by 80 members of Congress, arguing that the agency should fast-track approving the treatment. THE PACT ACT AT TWO — President Joe Biden signed sweeping legislation expanding benefits for veterans exposed to toxins like burn pits known as the PACT Act two years ago on Saturday, Ben reports. The legislation has meant the agency is serving more veterans than ever. According to the agency’s latest data, more than 1 million claims have been approved under the act totaling $6.8 billion in benefits. Still, the implementation hasn’t always been smooth. Of the 385,000 claims related to contaminated drinking water at Camp Lejeune in North Carolina, the government has made 114 settlement offers, CNN has reported. And The Washington Post has reported that dozens of for-profit companies are making hundreds of millions of dollars from the law — by charging veterans to help them file disability claims. The agency on Friday said it would offer benefits for veterans serving at a base in Uzbekistan just after the Sept. 11 terror attacks. Veterans had been frustrated that they were told to wait to see whether the VA would connect their illnesses to the toxic base. Earlier this year, the VA inspector general also found the agency doled out millions in bonuses to VA staff and officials under the PACT Act. The VA acknowledged a “policy error,” and Secretary Denis McDonough said the agency canceled payments to senior executives “as soon as we identified this error.” Now, lawmakers are trying to address a nearly $2.9 billion budget shortfall due to the major expansion of benefits. |
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