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Transcript for the audio podcast:
REMS Plans Assess Risky Drugs

From the Office of Inspector General of Department of Health and Human Services

https://www.oig.hhs.gov

[Jaime Durley:] I'm Jaime Durley, Deputy Regional Inspector General for the Office of Evaluation and Inspections. I'm speaking with Sarah Langford, a program analyst in our office about a report called FDA Lacks Comprehensive Data to Determine if REMS Improve Drug Safety. Sarah, can you tell us a little bit about the Food and Drug Administration, or FDA's REMS program?

[Sarah Langford:] Sure. Well, first of all, REMS stands for Risk Evaluation and Mitigation Strategies, which are plans that manage drugs' risks. FDA requires REMS plans for about 100 drugs that are associated with serious risks like death or injury. Without effective REMS plans, the drugs' risks may outweigh their benefits. REMS plans can range from something simple, like requiring doctors to provide additional reading material to patients, to something more complex, like requiring doctors to be specially certified before they prescribe a drug.

[Jaime Durley:] So, Sarah, why did you do a study on these REMS plans?

[Sarah Langford:] Well, some drugs would never have received initial FDA approval, or would have to be removed from the market without a REMS plan. In short, we did this study to determine if FDA is adequately monitoring these REMS plans and protecting the public from risky drugs.

[Jaime Durley:] So, you looked at how well FDA monitored these risky drugs. How did you go about doing that?

[Sarah Langford:] Well, manufacturers have to submit assessments to the FDA on the effectiveness of REMS in managing a drug's risks. So then the FDA then determines if a REMS plan is meeting its goals. So we reviewed 49 REMS assessments to see if the drug manufactures provided the information that FDA requested so that they could determine if the plans were meeting the goals to protect the public.

[Jaime Durley:] And what did you find out about these assessments?

[Sarah Langford:] We found that almost half of the REMS assessments did not include all of the information that FDA requested. Importantly, though, FDA does not have the legal authority to require pharmaceutical companies to submit this information. And that means that FDA can't fine manufacturers if they don't provide that information. Also, one of our most troubling findings was that FDA found that only 7 of the 49 REMS we reviewed have completely met their goals.

[Jaime Durley:] Only 7 of 49? Why do you think this number is so low?

[Sarah Langford:] That's a really good question. One reason is that FDA did not always have the information it needed to determine a plan's effectiveness. For 17 of the REMS plans, FDA couldn't determine if the plan was meeting its goals. Most often this was because manufacturers did not submit enough information, or submitted information that wasn't scientifically sound. Further, we report that most of the plans that weren't meeting their goals feel short of properly informing patients and prescribers about drugs' risks.

[Jaime Durley:] It sounds like this study raises some major concerns about the effectiveness of REMS plans.

[Sarah Langford:] Yeah, it does. So one of our recommendations was that FDA identify REMS plans that are failing to meet their goals and then take action to protect the public health. We also recommended that FDA identify reliable methods to assess these REMS plans. Very importantly, we recommended that FDA seek legislative authority to require manufacturers to submit specific information in assessments.

[Jaime Durley:] And how did FDA respond to our recommendations?

[Sarah Langford:] FDA fully agreed with six of our seven recommendations. On our seventh recommendation, however, FDA would only agree to consider seeking legislative authority to require manufacturers to submit specific information in the assessments.

[Jaime Durley:] Sarah Langford, program analyst for the Office of Evaluation and Inspections. I want to thank you so much for sharing this important work on plans intended to protect the public from risky drugs.

[Sarah Langford:] Thank you.

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