Blogs: For the Record

Is REMS Interfering With the Practice of Medicine?

Published Online: Wednesday, March 28, 2012


The FDA’s job is to protect the public health by ensuring the safety, effectiveness, and security of biological products, devices, foods, cosmetics, dietary supplements, and certain products that give out radiation. To accomplish this mission, the FDA evaluates products to ensure that only those that are safe, effective, and secure will be able to reach patients.
Selling a product for an unapproved indication would violate the law. However, once it’s been approved, health care providers can lawfully use and prescribe the product for treatments that are not included in the approved labeling. The FDA recognizes that these off-label uses or treatment regimens may be important therapeutic options and may actually even be the standard of care. However, despite this recognition, the FDA seems to be blurring the boundary of its jurisdiction with the use of Risk Evaluation and Mitigation Strategies (REMS).

W hat is R EMS?

The Food and Drug Administration Amendments Act (FDAAA) created REMS and allowed the FDA to use it as a tool to monitor a drug and ensure that its benefits outweigh its risks. REMS has the potential to interfere with the practice of medicine if it prevents physicians from exercising their own independent medical judgment or if it prevents patients from getting the medication that they need.

REMS Levels

REMS may be enacted in multiple ways, depending on the risk profile of the drug in question. The FDA may choose between the use of med-guides, additional studies and data points, timetables to submit results, and other elements to assure safe use (ETASUs). ETASUs might consist of additional training and registration requirements for patients and health care providers. Specifically, ETASUs may require that a product only be prescribed by certain prescribers and only if the patient qualifies for the product for the indication approved by the FDA. To meet these requirements, pharmaceutical companies will often contract with health care providers and hospitals only on the condition that they promise not to use the medication for anything other than the approved indication, with the threat of a discontinued supply of medication if the agreement is violated.


By limiting the supply of a medication, REMS effectively withholds drugs from prescribers despite the FDA’s admission that there may be appropriate off-label uses of certain drugs. In doing so, the FDA has moved beyond merely approving drugs and is now limiting independent medical judgment. Congress has never authorized the FDA to hinder the prescription of appropriately approved drugs. As a result, the FDA has opened itself up to challenge on the grounds that its use of REMS constitutes an overreach.
Darshan Kulkarni, Kulkarni Law firm
Blog Info
Darshan Kulkarni, a pharmacist and attorney based out of Kulkarni Law firm (Philadelphia, PA), will provide insights on the legal, regulatory, administrative, and ethical issues that can affect pharmacists in their everyday practice.
Author Bio
This blog will primarily focus on informing pharmacists about how the drugs that they dispense came to be in their hands—including the ethics, the arguments, the laws, and the drama. Among the topics covered are FDA regulations, drug development, clinical trial participation, compounding drugs, social media marketing, and pharmaceutical advertising. This blog will also discuss what pharmacists need to know about dispensing certain medications.

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory, and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years. He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products–Regulatory Considerations.

You can follow him on twitter at @FDALawyers ( or visit the Kulkarni Law Firm's Web site (

The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and/or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney–client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
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