Prior to 2007, it was not uncommon for widely used drugs to be taken off from the market for safety reasons, often leaving patients with few or no treatment alternatives for their diseases and medical conditions. That is why Congress passed the Food and Drug Administration Amendments Act of 2007 with new authority for the Food and Drug Administration (FDA) to require rigorous drug safety protocols, called “Risk Evaluation and Mitigation Strategies,” so FDA could approve valuable medicines known to pose serious risks or could keep these drugs on the market with safety restrictions.
However, because the REMS program is working, appreciation for these safety protections is waning. Instead, allegations persist that REMS protocols are overused or may not be necessary and some members of Congress are responding with legislative proposals that could put patients at risk of significant harm and open the door to drug diversion. Accordingly, patient advocates are urging policy solutions that increase generic drug development while ensuring all manufacturers – branded and generic companies – follow the same rigorous safety protocols when testing and marketing medicines known to cause birth defects, organ damage, serious infections and even death when not carefully controlled.
Why Preserving REMS Safeguards Is Necessary
Today, millions of Americans with serious diseases (cancers, Crohn's disease, bowel disorders, chronic obstructive pulmonary disease, HIV, lung conditions, multiple sclerosis, seizures, and schizophrenia) and rare disorders are being treated effectively with medications that may never have been available without REMS programs to ensure their safe use. And as more targeted treatments, like immunotherapies and gene therapy, become an option for patients, the need for REMS safeguards will only increase.
Yet, the REMS program is now embroiled in controversy due to FDA-mandated restricted distribution systems and other strict controls placed on a very small number of high-risk drugs, which can add extra steps for health professionals and make it more difficult for generic companies to obtain samples for testing purposes. Called “Elements to Assure Safe Use” or ETASU for short, FDA requires these safeguards only when therapies are associated with the most severe risks, including risk of birth defects and death. Similarly, rigorous REMS controls are necessary to prevent the distribution of drugs involved in sexual assault and stop drug diversion, especially now that that nation is facing a growing opioid addiction crisis. Based on information from FDA’s website, today only 46 medications now require strict ETASU controls and this includes 11 drugs or classes of drugs where both branded and generic versions are available to patients.
Even though ETASU restrictions are limited to a small number of very high-risk drugs, misperceptions are commonplace about the purpose and need for REMS protocols, resulting in a number of legislative proposals that are of concern to patient safety advocates. Of special concern are bills that would force the sale of high-risk medicines requiring REMS controls to generic drug developers but without sufficient safeguards to prevent harmful exposure.
Further complicating the situation, REMS has become a convenient target for legislators reacting to the tactics of certain bad actors, such as Turing Pharmaceuticals, to maximize profits by limiting the distribution of their medications. Unfortunately, what lawmakers don’t understand is that the drugs marketed by these bad actors are not restricted for safety reasons and thus, FDA did not mandate REMS protocols. Therefore, advocates are urging policies that reflect the differences between restricted distribution systems that are necessary for patient safety or to prevent drug diversion and those intended for non-safety purposes.
Patients Rising NOW supports the efforts of the Patients Alliance for Drug Safety Protections, a broad-based coalition of public health, patient advocacy, health professional and disease organizations, which is urging lawmakers to preserve the integrity of the REMS system by ensuring that any legislation to force the sale of drugs with ETASU requirements to generic manufacturers holds all manufacturers – branded and generic – to the same safety standards when testing and marketing high-risk drugs.
Focusing specifically on the “Creating and Restoring Equal Access to Equivalent Samples Act” (H.R.2212, S.974) or CREATES, which Congress is now considering, Patients Rising NOW and other patient advocacy organizations are urging lawmakers to:
Maintain established procedures whereby FDA ensures both innovator and generic drug makers are held to the same – and not “comparable” – safety requirements when testing potentially dangerous drugs
Ensure FDA has the authority and resources to verify that a generic developer has the safety track record and capability to implement a rigorous risk management system. This is necessary due to the number of warning letters FDA has sent to generic manufacturers, especially outside the US, citing inadequate testing and quality checks, inconsistencies in data collection, and contaminated products
Require that if generic companies set up a separate risk management system instead of using a single, shared REMS protocol, manufacturers must first demonstrate to FDA that their program matches the infrastructure, controls, materials and certification requirements as the shared system.
Food and Drug Administration website. Approved Risk Evaluation and Mitigation Strategies. June 1, 2018. Accessible at: https://www.accessdata.fda.gov/scripts/cder/rems
Consumer Reports. Are generic drugs like Apotex medication made in India safe? FDA sanctions against some Indian drug plants raise concerns about the U.S. generic drug supply. April 25, 2014> Accessible at: https://www.consumerreports.org/cro/news/2014/04/are-generic-drugs-made-in-india-safe/index.htm