A Deeper Dive: Recommendations for Strengthening the FDA’s REMS Program to Protect Patients

Lori Potter
Lori Potter
By Lori Potter, Senior Counsel, Government Relations, Kaiser Permanente

Several weeks ago, Institute for Health Policy Director Murray Ross shared a post on Kaiser Permanente’s response to U.S. Department of Health and Human Services’ request for comments on its “Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”

If you didn’t make it through our full 20-page letter, rest assured — you weren’t the only one!

That’s why we’re going to dive deeper into a few of the topics we addressed in the letter through a series of blogposts over the next several months.

Today, I will summarize our perspective on the Food and Drug Administration’s Risk, Evaluation, and Mitigation Strategies program — known as REMS — and offering thoughts on how policymakers can ensure the program is being used as intended.

What is the REMS program?

Sometimes, life-saving therapies come with potentially dangerous side effects. As part of the REMS program, drug manufacturers are required to design mechanisms to help patients, caregivers, providers, and others mitigate those risks so that patients can access the medications they need.

Depending on the level of risk, REMS requirements can be relatively simple — for example,  guidelines for patients and providers — or they can be more complex, such as specific lab-testing protocol, provider training, limited distribution through specialty pharmacies, and other “elements to assure safe usage” (or ETASU, an acronym that really rolls off the tongue!).

How are drug companies exploiting the REMS program?

While the aims of the REMS program are noble — to ensure that a drug’s benefit to patients outweighs its risks — some manufacturers have used REMS to deny generic manufacturers the drug samples they need to develop lower-cost versions of more expensive brand products. While REMS can appropriately limit access to drugs for safety reasons, the program was never intended to block the development of lower-cost generic alternatives.

Another inappropriate tactic that drug companies use is to restrict distribution of certain drugs through contracts with specialty pharmacies (or in some cases, a single pharmacy), which can affect access, affordability, and safe usage of these drugs.

Here’s an example of what this means for an integrated health care system such as Kaiser Permanente:

Using REMS, manufacturers can limit where their drugs are dispensed. When this happens, patients must go outside our system to a specialty pharmacy that the manufacturer chooses.

These instances disrupt our care coordination and safety features — for example, physicians and pharmacists can’t quickly share information about a patient’s medications. When we can’t automatically record the drug in patient’s electronic health record, a pharmacist may not be able to immediately identify a possible interaction with another medication.

How can we prevent REMS abuses from happening?

Kaiser Permanente has asked the FDA to re-evaluate the program to address the components that let drug manufacturers “game” the REMS process. Specifically, the FDA needs to prevent manufacturers from blocking generic competition — which would allow patients to have more and lower-cost drug options — or unnecessarily restricting distribution pathways through specialty pharmacies.

Two recent bills introduced in Congress seek to address the issue of limiting availability of samples to create generic equivalents: the Fair Access for Safe and Timely (FAST) Generics Act and the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. Both bills could result in substantial consumer and government savings by helping make lower-cost generics drugs available to patients more quickly.

To address abuses of limited distribution networks, we have also recommended that the FDA ensure health systems and pharmacies that can show they meet or exceed REMS requirements can access and dispense REMS drugs to their patients. In 2009, we filed a Citizen’s Petition with the FDA raising our concerns with features of the REMS program and suggesting ways that FDA could strengthen REMS to benefit patients.

We’ll continue to monitor these policy solutions and will keep you abreast of any changes. In the meantime, you can read our Drug Pricing 101 paper to learn more about this issue.

Download Drug Policy 101: FDA Risk Evaluation and Mitigation Strategy (REMS)