REMS - The acronym that will change your life
In 2007 the FDA was re-authorized with a significant new authority - the authority to require the establishment of Risk Evaluation and Mitigation Strategies - REMS. In a very short part of the reauthorization bill the entire world of marketing drugs in the USA was turned upside down - and not much has been said about it!
By on Dec 19, 2008In 2007 the FDA was re-authorized with a significant new authority - the authority to require the establishment of Risk Evaluation and Mitigation Strategies - REMS. In a very short part of the reauthorization bill the entire world of marketing drugs in the USA was turned upside down - and not much has been said about it!
In short, REMS is the process by which the FDA is going to require the establishment of effective post-marketing surveillance of all adverse events, drug-drug interactions, side-effects and so forth - and there is no restriction on the range of products they can address with this authority. Just because you've been on the market for a decade or two does not make you exempt.
I had a meeting recently with an established client. We were talking about a product that has been on the market so long it is close to patent expiry and yet the FDA have requested a REMS policy covering the product's use. This requirement was taking a substantial amount of my client's time and had caused the creation of an entire working group within the company. I said that I thought REMS would become the most significant policy factor in the marketing of all new drugs within the next decade.
Patient registries have been used in some areas for a while (particularly oncology)and companies will be tempted to use them in order to meet the needs of an effective REMS policy, Unfortunately, I think that the FDA is eventually going to lean away from this approach as a registry will frequently be seen as too limited in terms of overall data capture. Given that patients have multiple conditions and that the interaction of those conditions in terms of all aspects of management of care will affect safety outcomes, I think the FDA is eventually going to favor another aspect of the reauthorization bill that concerned the use of patient records.
In short, the bill requires that the FDA use electronic medical records as the primary source of data to track all aspects of product safety (and probably efficacy as well). The records being covered here are not billing based but are the actual patient charts. This is where worlds collide. The FDA is going to be using EMRs to assess product safety post-marketing; they are also going to be using EMRs to assess outcomes - and both safety and outcomes are going to be compared with pre-approval data as well as comparing drugs against each other in ways that no clinical trial ever could. I have no doubt that labels will be modified as a result of these activities - and the pharmaceutical industry will be required to support these activities (by which I mean pay for them).
The growing presence of health information exchanges, the clearly stated policies of the new administration and the burgeoning requirements of REMS will mean that we must all become very familiar with the presence of EMRs as a means of monitoring products post-launch. We can get into the details of how this can be achieved another time, but for now I strongly urge you to look closely at HIEs (especially Indiana), the activities of the caBig and Big Health initiatives at NIH and look closely at the subtle language coming out of FDA. REMS is here, it is here to stay and it is going to change the way we do business across the board - from that first Phase I trial through the entire life or the product.