Opioid REMS Pilot Program Urged At Public Meeting

FDA wrestles with balancing the urgency of patient safety with the desire for a well designed risk management program for pain products.

Before a full-scale risk evaluation and mitigation strategy for opioids is put in place, it should be tested in a pilot program to assure it works, patient advocates told FDA at a public meeting May 27.

Agency officials were interested but skeptical of the concept proposed on the first day of a two-day meeting aimed at airing the vast implementation challenges that will come with implementing a restrictive REMS for the widely used pain products.

"How do we reconcile the urgency of protecting patient safety with the desirability of creating a well-designed REMS program?" asked Office of New Drugs Director John Jenkins.

The recommendation for a pilot program highlight the fine line FDA must walk in developing a REMS for opioids - an issue that has pitted patient and pain advocacy groups against one another. While pain patients underscore their legitimate need for access to opioid products, critics of the drugs call for them to be stripped from the market, or at least limited to cancer patients.

For sponsors of opioid products, a pilot program seems to offer a chance to delay a potentially painful implementation of the REMS on a full scale; the pilot would also give sponsors who participated a stronger role in designing the final program.

For products pending at FDA, however, a pilot would almost certainly mean further delays since a agency decision on a REMS appears to be the primary issue standing in the way of approval (see ¹ (Also see "Opioids Stuck In Pipeline Should Not Wait For REMS, National Pain Foundation Says" - Pink Sheet, 27 May, 2009.) ).

FDA recognized the need to ensure that a finalized REMS would be an effective one, but questioned how it would go about choosing geographic locations or specific drugs to test in a pilot program. "What regions, what states, who would it be for? I think we're getting into a 'Not in my back yard' thing," said CDER Deputy Director Douglas Throckmorton.

Cancer Pain As A Test Case

In turn, a few of the presenters recommended a "temporary moratorium," in which a short-term program could be implemented that would change labeling to restrict opioids to patients with cancer or non-cancer patients through compassionate use, and require a more thorough physician education, thereby decrease misuse and abuse.

"If properly implemented, the moratorium would give FDA the time it needs to take to come up with a pilot program that would be effective," said Peter Jackson, Advocates for Prescription Opioid Drug Reform.

In addition to outright banning oxycontin, critics of opioids recommended a number of actions, including additional training for physicians, health literacy programs for the public, and increased development of abuse-resistant drugs.

Patients advocating pain medication for legitimate patients noted that the point of a REMS is to balance risk with benefit, but in their opinion, the scale is already tipped. "We cannot find doctors to treat us; we cannot find pharmacies to fill our prescriptions. I have had all the balance I can take," said pain patient and advocate Mary Vargas, who pointed out that the language surrounding REMS says the program shall not supposed to "unduly" burden patients.

"Our access to pain care is already unduly burdened," she said, adding that opioid patients often are required to submit toxin screens, urine tests, and are turned away from doctors that are scared to treat them.

It's rare for an FDA meeting to consist solely of patient and drug advocates sharing personal stories and fiercely pleading with the agency to change its regulations. The first day of this hearing lacked the science-laden discussion typical during product oversight gatherings, highlighting the difficulty and sensitivity of the drug class - and emphasizing the increased role that patients are playing in REMS issues overall (² (Also see "REMS Meeting For Opioids Shows Key Role Of Patients" - Pink Sheet, 26 May, 2009.)).

But opioids present a special case, whereby the safety program must be designed with both patients and non-patients - those who misuse, abuse and are not prescribed the medication - in mind. As Pinney Associates May 26 press release highlight, "This raises the important question of whether a REMS can both protect patients to whom a medication is prescribed and minimize use by non-patients."

During day two of the meeting, May 28, FDA will hear from pharmaceutical companies and service firms that would implement the REMS.

-Lauren Smith (³ [email protected])