FDA Faulted For Inability To Properly Manage Drug Risks

The Office of the Inspector General (OIG) at the Department of Health and Human Services has recently released a report calling into question the effectiveness of the Food and Drug Administration’s (FDA) strategy for managing drug risks.

The OIG said they did the study because The Food and Drug Administration (FDA) requires manufacturers to submit structured plans, known as Risk Evaluation and Mitigation Strategies (REMS), for drugs associated with known or potential risks that may outweigh the drugs’ benefits. If the FDA does not properly monitor REMS’ performance, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks. However, the FDA does not have the authority to require, but may request, drug manufacturers (i.e., sponsors) to submit specific information regarding REMS’ effectiveness.

The 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 the 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 the 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 were 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 they first received the medicine. Another situation where these risk mitigation plans were used involved scheduled narcotics that could be accidentally ingested by children. The 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 the FDA received explicit authority from Congress to demand these arrangements are part of drug approvals. Gone was the “voluntary” nature of the scheme, where the FDA would effectively pressure companies into agreeing to the restrictions in order to get their products approved. After 2007, the FDA had the explicit legal authority to demand the restrictions. But Congress also tasked the FDA with oversight to make sure that the programs were having their intended public health benefits.

The OIG report reviewed approved REMS implemented since the program’s “legal” inception in 2008, all the way through 2011. The 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 the FDA “assessment plans,” and 10 were not submitted to the FDA within required timeframes. The FDA determined that only 7 of the 49 REMS reviewed met all of their goals.

The OIG stated in their report that their “findings raise concerns about the overall effectiveness of the REMS program.”  To address these concerns, they made seven recommendations regarding the FDA’s evaluation and assessment of REMS and its review of sponsors’ REMS assessments. The FDA concurred with six of our recommendations. For the remaining recommendation, to seek legislative authority to make the FDA assessment plans enforceable, the FDA did not state whether it concurred or did not concur. However, the FDA agreed that this recommendation should be considered if another opportunity arises to pursue legislative changes to the statutory provisions that describe the requirements for REMS assessments.

Although, according to the recent report, OIG says that the FDA fell short in how it implemented the provisions, is it really their fault?  Or is the system set up to fail?

According to an article in Forbes, “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 the FDA and the drug makers had legal, if actual control over what doctors did and how they prescribed medicines. The FDA doesn’t have this authority and drug makers can’t exercise that sort of control.”



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