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The Office of the Inspector General (OIG) at the Department of Health and Human Services released a report today calling into question the effectiveness of a key piece of the Food and Drug Administration’s (FDA) strategy for managing drug risks.
The report evaluated “Risk Evaluation and Mitigation Strategies” (REMS) that FDA imposes as a condition of approval of certain drugs. FDA uses REMS in situations where regulators have significant concerns that a drug has an unpredictable, severe, and potentially avoidable risk. REMS are a strategy FDA first adopted in the late 1990s as “voluntary” agreements that drug makers make with the agency. Sponsors would enter in to these arrangements with FDA as a condition of approval. In most cases, the companies promised to put in place restrictions on how drugs would be used by doctors. These limitations we meant to help mitigate the agency’s safety concerns, and make it easier to get a new product to the market.
These plans might, for example, involve pregnancy testing before woman can use a drug that is known to cause birth defects; or for drugs that could cause an immediate and severe allergic reaction (anaphylaxis), special monitoring of patients when the first received the medicine. Another situation where these risk mitigation plans were used involved scheduled narcotics that could be accidentally ingested by children. FDA often required risk management plans that would help keep the narcotic drugs secure in the home and out of the hands of small kids.
Over the years, these arrangements evolved. They became dubbed REMS in 2007 when FDA received explicit authority from Congress to demand these arrangements are part of drug approvals. Gone was the “voluntary” nature of the scheme, where FDA would effectively pressure companies into agreeing to the restrictions in order to get their products approved. After 2007, FDA had the explicit legal authority to demand the restrictions. But Congress also tasked FDA with oversight to make sure that the programs were having their intended public health benefits.
Enter the report today. In it, the OIG says that FDA has fallen short in how it implemented these provisions. But it’s hard to blame the agency. It was inevitable that these strategies would be hard to execute, and even more difficult to impose and monitor. The risk mitigation plans presupposed that FDA and the drug makers had legal, if actual control over what doctors did and how they prescribed medicines. FDA doesn’t have this authority and drug makers can’t exercise that sort of control.
Right now, FDA foists on drug makers the responsibility to make sure doctors comply with the REMS restrictions. The drug makers, in turn, have to impose these things on prescribers (and then monitor whether the physicians comply). But how? The entire arrangement is predicated on authority and a measure of control that neither the agency nor the companies actually possess. It should come as little surprise, that doctors aren’t heeding the requirements, and the drug makers are having a very hard time monitoring compliance and measuring the outcomes (and reporting this information back to FDA). These were often flimsy arrangements.
The OIG report reviewed approved REMS implemented since the program’s “legal” inception in 2008, all the way through 2011. FDA approved 199 REMS over that time; 99 of which were still required in 2012. Nearly half of the assessments for the 49 REMS that the OIG reviewed did not include all information requested in FDA “assessment plans,” and 10 were not submitted to FDA within required timeframes. FDA determined that only 7 of the 49 REMS we reviewed met all of their goals.
While it might seem logical to blame the drug makers for not monitoring their plans, there’s a bigger challenge hampering these goals. FDA has not identified reliable methods to assess the effectiveness of REMS. Nobody really knows how to evaluate whether the REMS are working. In fact, nobody has done rigorous work to evaluate which risk mitigation strategies are best suited for dealing with certain kinds of side effects. In short, there isn’t a whole lot of science guiding these regulatory burdens.
The OIG wants to give FDA more authority, so the agency can make its assessment plans enforceable. But FDA should be mindful what it asks for. The agency should be careful about taking on a requirement that it has no ability to adequately enforce. The agency can compel drug makers to monitor the REMS, but it can’t compel the doctors to submit to all the requirements. Neither can the pharmaceutical firms. In a fragmented drug supply chain, it is hard for the drug makers to “cut off” the doctors that don’t comply with all the previsions, and it might not be desirable. True enough; the REMS give some comfort to drug regulators who might be concerned about how doctors would prescribe a newly approved drug that had certain significant risks. But the challenges that FDA is having with implementing, and monitoring these plans should be a reminder that the agency doesn’t have as much leverage over medical practice as they would desire.
There’s a broader lesson here. Too many of the agency’s decisions and judgments are starting to turn on FDA’s desire to regulate aspects of the practice of medicine. The agency wants to make sure that doctors conform to the FDA’s judgment about how new products should be used. But FDA’s control over medical practice is tenuous, and will remain so. Efforts to exert more leverage will only alienate the providers that FDA relies on. And the agency’s judgment isn’t always in sync with the kinds of considerations made in everyday clinical practice, anyway.
The FDA may the final arbiter of the medical products that get approved. But its judgment should not stand in for the considerations that get made in the real world, where doctors and patients have to balance difficult issues to arrive and the right decisions. Where treatments are ultimately tailored to each person’s unique circumstances and needs – and the conclusions highly personal.
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