Worried that REMS programs may add to healthcare costs, Kaiser Permanente filed a citizen’s petition asking the FDA to take several steps to mitigate the effect of these programs, particularly a portion known Elements to Assure Safe Use, or ETASU.

Kaiser claims the FDA failed to seek public input from patients or health care providers about implementing REMS, or Risk Evaluation and Mitigation Strategies. For Kaiser, the issue is that the ETASU may increase obligations of health care providers and, as a result, increase costs to the point where a REMS outweighs benefits. Kaiser wants health care providers and insurers to be consulted before a new REMS with an ETASU is implemented. Here is the petition with its requests.

“Kaiser has a dog in the hunt, for sure, but the logic seems sound. One aspect of the ETASUs is that they may provide drug manufacturers with the ability to limit access to healthcare providers on a selective basis, i.e., those with whom contracts have been established. Kaiser notes that the necessity to acquire drugs through specialty pharmacies (at higher than WAC prices) can result in providers paying more for the drugs than might normally be the case,” writes William Tanner at Lazard Capital Markets, in an investor note.

Hat tip to FDA Law blog