Facts and Figures: True or False

REMS Myths and Facts

In 2007, Congress gave the Food and Drug Administration (FDA) the authority to use Risk Evaluation and Mitigation Strategies (REMS) in order to protect patients taking certain high-risk medicines. Yet, since then, the sense of urgency that led to these drug safety protections has been replaced by a number of misperceptions about the role of REMS in preserving patient access to medicines.

To help end the confusion, here are the up-to-date facts to dispel common myths about REMS.


MYTH

REMS safeguards are excessive.

FACT

Without REMS protections, the first gene therapy available in this country and needed treatments for rare disorders and serious diseases would not be on the market today. These drugs have serious risks, including life-threatening infections, severe allergic reactions, liver damage, birth defects, addiction, drug abuse and diversion. The FDA can only let them on the market if there are safety protections – REMS – in place to ensure the benefits of the medicine outweighs the risks. Because a medicine’s specific REMS safeguards are required by FDA in order to make the drug available to patients, those REMS safeguards are not excessive but rather necessary for patient access to needed therapies.

 

 

MYTH

REMS are applied too broadly and too often.

FACT

REMS only apply to medicines known to carry serious risks and each REMS consists of specific safety measures tailored to the particular risks associated with that particular drug or class of drugs. Currently, only 61 REMS programs are approved for the thousands of medicines now on the market. Of those, 51 have “Elements to Assure Safe Use” (ETASU), the most stringent component of REMS. In addition, FDA has dramatically reduced the frequency with which it requires REMS programs, and has eliminated over 200 REMS to date. To see a complete, searchable list of the medicines that are subject to REMS, click here: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.page

 

 

MYTH

REMS programs with distribution restrictions have increased dramatically in the last several years.

FACT

REMS programs are limited to life-saving medicines that come with high risks. Today, there are 51 REMS with ETASU including distribution restrictions. 13 REMS with ETASU are shared systems, which allow products from multiple manufacturers, including generic manufacturers, to be distributed using the same safety protocols.

 

 

MYTH

REMS create a burden on doctors and patients.

FACT

REMS are not paperwork. They are safety work and consist of important steps like checking patients’ blood work before giving a drug or educating doctors to be aware of potential serious side effects and to intervene in a timely fashion. REMS are aimed at a specific, serious risk, and designed to reduce that risk so that patients are protected but still have access to the drug. For example, Soliris, the only drug that treats a rare blood disease, carries a risk of meningitis. The REMS for this drug includes education and certification of doctors who prescribe the drug, and a requirement that patients be vaccinated against meningitis prior to receiving their first dose of the drug. Patients taking the drug also carry a safety card with them to show any health care providers who may treat them so that they can be quickly diagnosed in case of infection.

 

 

MYTH

Brand drug manufacturers can decide on their own to implement a REMS program.

FACT

Manufacturers can propose a REMS, but only FDA can require one. In most instances it is FDA, not a manufacturer, who determines a REMS is needed, and only FDA can approve a REMS.

 

 

MYTH

REMS, especially restricted distribution systems, impede generic drug development.

FACT

A growing number of medicines subject to REMS have gone generic, including those requiring strict controls called “Elements to Assure Safe Use” (ETASU). Additionally, there are 13 shared systems where both branded and generic versions of REMS drugs are made available to patients with the same safety requirements. This means that generic medicines with REMS restrictions are now available to treat acne, breakthrough pain resulting from cancer, diabetes, opioid dependence, and the prevention of organ rejection after transplant. These approvals are the result of established procedures where the FDA permits a branded manufacturer to sell quantities of drugs subject to restricted distribution to a generic manufacturer for clinical (bioequivalence) testing.

 

 

MYTH

The use of REMS-like programs is on the rise.

FACT

Either medicines are marketed with REMS requirements or they are not – there are no REMS-like programs. Unfortunately, critics of REMS have been successful in conflating FDA-mandated REMS controls on potentially dangerous drugs with voluntary, non-REMS programs put into place by individual companies for specific reasons.  As a result, REMS programs have been incorrectly linked with the practices of some industry bad actors, such as former CEO of Turing Pharmaceuticals, Martin Shkreli, when the decision to require restricted distribution as a REMS protection is limited to the FDA.

 

[i] Soliris Prescribing Information. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM217725.pdf (Accessed September 29, 2015).