The increasing number of Risk Evaluation & Mitigation Strategies for drug and biotechnology products could cripple the current health care system - and force an overhaul of the way REMS are administered.

While that rallying cry is often heard from pharmacy groups and drug sponsors, FDA, which recently gained the authority to impose the strict risk management programs, also recognizes that the current system is quickly growing antiquated, and believes that changes need to be made.

"What ideally we need to achieve ... is a health care system that can accommodate any of the REMS programs," FDA Office of New Drug Director John Jenkins said in an interview.

"We need to get away from having programs that are run by individual sponsors or contractors, and get to a place where the pharmacy distribution system and the health care system itself can accommodate all of these REMS programs."

Something needs to change soon, Jenkins warned: "We can't keep trying to come up with an individual system each time...Eventually, the system is going to collapse under the weight of multiple programs."

Only A Matter Of Time

Since gaining the REMS authority in March 2008, FDA has approved more than a dozen REMS for single products, in addition to a class program for fluoroquinolone antibiotics (¹ Also see "The REMS Report Card: FDA Using New Tools For One-Third Of New Drugs In First Six Months" - Pink Sheet, 10 November, 2008., p. 25).

And that is just the tip of the iceberg. Multiple products pending at FDA will require a REMS prior to approval, and the agency is planning class-wide REMS for erythropoietin stimulants, anti-depressants, anti-epileptics, and, most recently announced, potent opioid products.

More class REMS are likely. While Jenkins couldn't comment on whether any others were in the works, he said FDA won't hesitate to add to the list.

"If we do see another situation where we do feel there is a need for a class-wide REMS with elements to assure safe use, than we would follow the same path, and make sure that there is one program, like we did with isotretinoin, and not multiple programs."

Most of the current REMS programs aren't too onerous; many require only a Medication Guide or, in the case of EPO, are for relatively small product categories. But REMS for other products, like GlaxoSmithKline/Adolor's Entereg and Amgen's Nplate , are much more involved, and are more taxing on the health care system.

The opioid program will be in a different category altogether - and raises the question of how much the system can handle. Pharmacies are already chafing under the MedGuide requirement; the class REMS for opioids will be an even greater burden (² Also see "MedGuide Requirements Need To Be Overhauled, Pharmacy Groups Tell FDA" - Pink Sheet, 25 August, 2008., p. 9).

"We started this out many years ago with programs that were relatively small, and now we're bumping it up to a class of drugs where there are 21 million prescriptions," Jenkins said. "That's orders of magnitude larger than the iPLEDGE program, which I think is the largest one heretofore."

"We've moved to a more centrally-based electronic system, but it is still a unique system from the opioid program that we'll be developing, or the thalidomide program. They all need to be accommodated by one over-arching system."

What Will A New System Look Like?

Jenkins expects that the issue will be part of a bigger-picture discussion as FDA and stakeholders debate the class-wide REMS for opioids. The agency is planning a series of meetings - culminating in one open to the public later this spring - about the parameters of the class program.

"We're expecting that will be part of the bigger conversation around the opioids REMS: how can we start moving to a place where the system - and I mean all-encompassing of the health care system - can accommodate these REMS," he said.

"We need a system where a pharmacy doesn't have to call the iPLEDGE program or the new opioids program to decide whether or not the doctor who wrote the prescription is enrolled and registered."

"It needs to be built into the system somehow," Jenkins said, like the way a pharmacist can check the status of a patient's insurance coverage at the counter, without needing to place a call to the insurance company.

- Lauren Smith (lauren.smith@elsevier.com)

The Downside Of REMS: An Over-Taxed Health Care System – FDA’s Jenkins

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