FDA wants drug companies to enforce REMS with physicians but is this realistic ?

REMS.  Risk evaluation and mitigation strategies are increasingly being used used on prescription drugs and the FDA wants drug companies to enforce physician compliance with REMS requirements  by cutting off prescribing rights for medications that have the most restrictive REMS.

First a primer:

What is a REMS and why is it used ?

REMS is Risk Evaluation and Mitigation Strategy.   The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. You can see a list of drugs that are required to use REMS here.

How are REMS used ?

There are different levels of REMS from Level I through Level III.   Elements of a REMS include:

• Medication guide (PPI)
• Communication plan
• Elements to assure safe use
• Implementation and tracking system
• Timetable for submission of assesments

A Level I REMS has to include a medication guide that is issued to patients every time they get their Rx filled.  It has to outline key safety and adverse precautions and advise the patient that the drug has certain risks.  An example might be an antidepressant that has the risk of thoughts of suicide in some patients.

A Level II REMS includes a communication plan with the sponsor.  Typically this means a communications plan to health care professionals who write Rx’s for the drug.  Drug companies must advise HCP’s in advance to changes in the label.  This communication can take the form of a mailing, eMail, or a combination of channels.

A Level III REMS includes elements to assure safe use and requires a lot of paperwork by both the physician who writes/administers the Rx, the patient, pharmacies, and potentially hospitals.  All adverse events have to be collected and analyzed and reported to the FDA.  Drugs with a class III REMS usually have controlled distribution and both physicians and patients have to provide information, such as a medical history or lab test results when the drug is started and periodically thereafter, as often as each time a refill is needed or every six months.

My guess is that most physicians believe the paperwork required for a Level III REMS is a big pain in the...

The key issue is that FDA requires requires drug companies to enforce the paperwork aspect from physicians, patients, and pharmacies.  For example, if a physician does not supply the required paperwork back to the drug company, the FDA wants the drug company to “cut off” the physician from using and prescribing the drug. Hospitals that do not return paperwork would be prevented from having the drug in stock, and some of these drugs are used for emergency situations.

So why is this causing a problem ?

Well it can take a lot of time to fill out the required paperwork.  Time which most physicians and health care professionals don’t have.  Physicians want to be compensated for that time and drug companied are caught between a rock and hard place in trying to enforce this aspect.  Can you imagine a pharma company threatening to cut off a physician from prescribing a drug because she/he did not submit paperwork ?  That is really going to endear the drug company with the physician.

The key question is “who is in the better position to enforce REMS ?  The drug company or the FDA ?”   My personal opinion is that the FDA needs to enforce this, not the drug company.  What is a drug company supposed to if a physician won’t complete the paperwork ?  There is a delicate balance between enforcement and treating a physician as a health care professional and customer.

For more information and to comment please go here.