USA – FDA Withdraws Proposed Rule on Generic Label Changes

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. For our part, the FDA is committed to a thorough, science-based review of the data and information submitted by drug manufacturers and the corresponding product labeling. Our goal is to ensure that the benefits and risks are clearly articulated in drug labeling. That patients and providers have accurate information. And that the benefits outweigh the risks for the intended patient population.

We recognize the decisions surrounding which drug to use in a treatment regimen can be complex. And often cost plays a role in those decisions for patients and health care providers. We also know there are impacts of these decisions on the health care system overall. When looking at the broader impact of our regulations, the agency must weigh and balance the potential impact of our actions especially as it pertains to consumer access to high-quality, lower-cost generic medicines. These are matters of public health concern. One such issue the FDA has considered extensively over the past few years is the process by which drug companies update drug labels and communicate safety-related information for generic drugs.

In November 2013, the FDA proposed a rule (Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products), which, if finalized, would have allowed generic drug makers to independently – meaning, without prior FDA review and approval – update and promptly distribute new safety information in drug labels. This is something that currently only branded drug makers can do.

This rule, if implemented, would have allowed generic manufacturers to independently update their drug labels with new information. We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities. We heard arguments that the proposed rule could impose new costs on generic manufacturers that might have raised the price of generic drugs to patients, potentially impacting patient access to generic medicines. And, among other challenges, the new policy would have resulted in labels for the same drug that varied between different generic manufacturers, for some period of time. This could have led to consumer and provider confusion.

Today, the FDA is withdrawing this proposed rule. At the same time, we’re taking important steps to update the labels on certain generic cancer drugs with modern safety and efficacy information. This effort will help make sure that prescribers and patients have the most up-to-date information to guide treatment decisions and will broaden patient access to generic medicines.

These actions are part of our ongoing commitment to promote a framework that ensures that generic drug labels reflect up-to-date, science-based information to inform patients and providers; while also balancing the need to maintain a pathway for the development of generic drugs that is modern, efficient and low cost.

As with all decisions we make, we carefully weighed the potential benefits of this proposed rule against the challenges it could impose. We want to provide background on this process, the FDA’s decision and the overarching public health considerations that were weighed. And, more broadly, we want to outline some of the current efforts the FDA is undertaking to help modernize generic labels.

Since that 2013 proposal, there’s been an important and robust public debate. It included extensive public comments received on the proposed rule and during a related public meeting in 2015. This debate has resulted in the FDA carefully considering over the past few years policy approaches on how best to improve communication of important, newly acquired drug safety information to providers and patients.

We’ve carefully considered all of the feedback we received from the various stakeholders – both in favor of and against the proposed rule. We’ve evaluated whether there are more effective and efficient ways of keeping generic drug labels up-to-date with the latest safety information and helping to ensure that generic companies continue to engage in an appropriate level of post-market safety surveillance.

Fundamentally, we believe that the withdrawal of the proposed rule is in the best interest of the public; and that other steps that we’re pursuing can achieve our goals.

For a multisource drug (typically an older drug that is available as both a generic and brand medicine), there are generally several manufacturers that will make a generic version. The question posed by the proposed rule was whether each drug maker should be able to independently update its label. In our review of the issue, we uncovered several hurdles that – if the rule was implemented – could compromise public health…