For the past couple of years, the FDA safety program known as the Risk Evaluation and Mitigation Strategies, or REMS, has been all the rage. The idea was hatched in response to growing concerns that safety signals were insufficiently handled before and after drug approvals (Merck’s Vioxx painkiller was an oft-cited example, for instance).

And so the agency has used the REMS program as something of a carrot and stick by requiring drugmakers to implement such a program as a condition of numerous approvals (here is the most recent list). Of course, not every REMS program is alike in that requirements can differ and, therefore, the effort and cost to design and execute each program involves something less than a cookie-cutter approach.

Not surprisingly, therefore, a new survey indicates drugmakers and others effected are offering a bit of pushback. Only 22 percent believe REMS is an improvement and three-quarters of respondents says the overall REMS program needs a major overhaul. Meanwhile, 68 percent say REMS is a “poor substitute” for other improvements needed system-wide in drug education, communication, monitoring of use, patient access and delivery of care; 58 percent say two years are required to effectively measure the benefits of a REMS for an already marketed drug, and 86 percent believe that, under current guidelines, risk and benefit information was not well-balanced in REMS communications.

“Most respondents said it is virtually impossible to measure the benefits of a REMS, compared to its burdens on patient access and cost of health care delivery, for a newly approved drug, and that even for an already-approved drug, it would likely require two years or more to effectively conduct such an assessment,” says Christopher-Paul Milne, associate director at the Tufts Center for the Study of Drug Development, which conducted the survey and is partly backed by industry (see the statement).

Other findings: 54 percent feel that it is possibel to offer all stakeholders an opportunity to participate in developing a REMS program without delaying drug approval or launch. And 86 percent believe such a program, in the future, should first be tested as a statutorily mandated pilot. [We should note that the survey canvassed just 28 people - three patient advocates; eight folks from biopharma companies; two payers; eight pharmacists and seven healthcare providers.]

Of course, assessing a new program can always be difficult and benefits are not always clear until the approach has been tried for awhile. What we don’t know is the extent to which cost factors into the thinking because this was not cited as a specific issue.