ContractWhat is REMS?

REMS or Risk Evaluation and Mitigation Strategies is a process in which the FDA effectively evaluates drugs once they have been introduced into the market.


Some argue that a REMS effectively constitutes conditional approval. Depending on the risks associated with the drug, there may be various types of REMS that may be imposed on the industry. The range varies from providing a “medication guide” (sort of a simplified package insert), to having a communication plan (a way to communicate with healthcare providers), to ETASUs (Elements To Assure Safe Use). Under a REMS, there may be training, registrations, or registries of healthcare providers.

Additionally, a REMS plan may include an implementation plan in which hospitals would contractually agree to restrict the use of a product to the on-label use only in exchange for access to these products. Such a limitation, in the FDA’s opinion, will help ensure the safe use of the drug.

Problems with Restricted Uses

The Supreme Court has held that the Food, Drug, and Cosmetics Act (FDCA) “expressly disclaims any intent to directly regulate the practice of medicine.” The FDA, deriving its authority from the FDCA, therefore has no jurisdiction on the practice of medicine.

Medicine is “mastered by graduate students in medical school devoted to preventing or alleviating or curing diseases and injuries.” A physician must be able to practice medicine the way he deems appropriate to prevent, alleviate, or cure a disease. Restrictions on the practice of medicine by the industry and hospitals on the behest of the FDA constitutes an imposition on the practice of medicine by physicians.

If a physician knows the risks associated with a drug and still wants to use it for an indication for which it has not been approved, the FDA should have no authority to prevent such use. However, the FDA has done this implicitly using REMS. The FDA is, therefore, interfering with the practice of medicine. This restriction shall, almost definitely, have an impact on patient care.

Why Do Drug Companies Agree to Allow for REMS?

Adverse Positioning:

The industry has failed to stand up to the FDA because of the potential financial impact of such actions. Standing up to the FDA would, theoretically, makes the FDA antagonistic to an individual company’s products. If a company has multiple drugs in the pipeline, standing up to the FDA at such a time may not be the smartest strategy.

Delays in Approvals:

A delay during negotiations with the FDA could potentially delay the patent life of the drug. Hence, it is often cheaper to agree with the FDA.

Peer Pressure:

As a member of the industry, competitors may accept the existence of REMS. Creating waves, when one’s competitors are not doing the same, is often unsound business strategy. Thus, agreeing to a REMS may also be influenced by peer pressure.

For more information on this issue, contact the Kulkarni Law Firm.