Introduction

Section 505-1 of the Food and Drug Administration Amendments Act (FDAAA) allows the FDA to require a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of a drug outweigh the risks. Recent news regarding REMS and the manipulation of their implications by drug manufacturers has brought to light some of the loopholes in Section 505-1 as well as logistical issues related to the dispensing of REMS-controlled drugs.

Background

A REMS can contain a Medication Guide, a communication plan, or a communication-related Element to Assure Safe Use (ETASU) and can be applied to new drugs, generics, and biologics. A REMS may be required of a previously approved product if additional safety information becomes available.

A REMS program is intended to ensure that the benefits of a drug outweigh the risks, but recent reports suggest that these programs may also be limiting patient access to drugs for reasons unrelated to safety.

Issue

Are REMS programs limiting patient access to drugs for reasons unrelated to safety?

Rule

REMS programs are limiting patient access to safe drugs if:

  • Patient access to a drug requiring a REMS program has been limited due to at least one reason unrelated to the safety of the drug.

Analysis

A March 2012 panel discussion including experts from the US Food and Drug Administration, the American Pharmacists Association, and private practice addressed the use of risk evaluation and mitigation strategies and brought to light some important issues regarding REMS programs.

RN Lisa Gorski recalls that the stringent requirements of some REMS programs include competency tests for nurses, which often become a limiting factor for a particular clinic to be able to administer a drug, in result limiting access for patients to be able to receive that treatment. Dr. Marcie Bough adds that at times patients are excluded from receiving a drug if the drug is part of a closed or restricted distribution program and their regular pharmacy is not part of the network of that particular REMS program, thereby limiting patient access to that drug. Dr. Bough discusses logistical problems in the middle of trying to dispense REMS controlled drugs in pharmacies, mentioning that internet access can vary across retail settings, often times delaying or offsetting the ability to access the programs needed to properly dispense a drug such as Isotretinoin, which requires the iPLEDGE program.

A recent article in the Washington Post talks about how the development of cheaper, generic versions of many REMS-controlled drugs has been restricted due to the exploitation of a legal loophole by big drug companies. A Senate bill provision prevents drug makers who manufacture REMS-controlled drugs from restricting sample sales to generic drug companies as along as they agree to follow FDA-approved safety procedures. The problem is, the House version of the bill does not include the provision.

Some branded drug manufacturers are using restrictive distribution policies to prevent the development of generic drugs, and they’re using REMS to do so. They are refusing to sell samples of their REMS-controlled drugs, claiming they are under no legal obligation to sell products to a competitor and exposing themselves to liability risks associated with providing large quantities of drugs with known dangers for human testing. If generic companies cannot obtain samples, they are not able to develop their equivalent, cheaper version for the public, thereby limiting patient access to REMS-controlled drugs that some patients cannot afford.

Conclusion

Patient access to a drug requiring a REMS program has been limited due to logistical issues and well as legal loopholes, therefore REMS programs are limiting patient access to drugs for reasons unrelated to safety.

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