The FDA wants to discourage the use of single-arm trials for accelerated approvals of oncology drugs; Cigna’s review system allows doctors to reject claims without reading them, an investigation shows; US bishops want to restrict gender transition care in Catholic hospitals.
FDA Seeks More Rigorous Approvals for Cancer Drugs
The FDA is proposing a more thorough process for accelerated approvals for cancer drugs, according to Reuters. This proposal was made following criticism over accelerated approvals after some drugs which had been approved under this process that were later deemed ineffective. Under the new approval process proposed by the FDA, RCTs are preferred; drug companies would be required to conduct randomized controlled trials in which patients would receive either a therapy or alternative treatment with a comparator. The guidance allows single-arm trials in limited circumstances.
Cigna Reject Claims Without Full Medical Review
In a joint investigation by ProPublica and The Capitol Forum, internal documents and former company executives said Cigna is saving millions of dollars by having its doctors reject claims without reading them. Under Cigna’s procedure-to-diagnosis (PXDX) review system, claims would automatically be denied payment for a treatment that didn’t match a set list of tests and procedures approved for certain illnesses. According to internal documents, over a 2-month period last year, Cigna doctors denied more than 300,000 requests under the PXDX method and spent an average of 1.2 seconds on each case. In a written response Cigna denied the findings but would not provide additional information.
US Bishops Aims to Restrict Gender Transition Care
In a 14-page paper, titled “Moral Limits to the Technological Manipulation of the Human Body,” US bishops want to prohibit Catholic hospitals from providing gender transition care, according to The Associated Press. In this document, Catholic hospitals “must not perform interventions whether surgical or chemical, that aim to transform the sexual characteristics of a human body into those of the opposite sex, or take part in the development of such procedures.” Catholic hospitals make up a large portion of health care systems and are the only option for care in some areas of the United States. According to the Catholic Health Association, which includes more than 600 hospitals and 1400 long-term and other health facilities in the United States, more than 1 in 7 patients is cared for in a Catholic facility.