The United States Food and Drug Administration (FDA) has once again pushed back the release of a final rule allowing generic drug makers to update safety labels detailing new risks without agency approval to July 2016. This final rule has been surrounded by controversy as it has many implications for safety obligations and liability of generic drug companies.
Background
Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs) cannot independently update their product labeling with newly acquired safety information. This stands in stark contrast to companies with new drug applications (NDAs) and biologics license applications, who are able to update their product labeling when new safety information is released.
Currently, when a generic drug company notices a safety issue that has yet to be indicated on its reference product’s label, the generic company cannot do anything to alert the public consumers to any imminent concerns. Having such a restriction on generic drug companies can raise serious liability issues for them.
For example, if a company manufactured a cholesterol-lowering drug that killed some patients by causing them heart attacks and the company was found to have known about those risks but failed to warn potential consumers, the company can be sued by a consumer for failing to disclose the known risks and information. However, it gets complicated because a generic drug company, upon finding out about the heart attacks associated with their drug cannot update the label of its drug to warn consumers because then the labeling would be different from the original reference drug, which is prohibited under 21 C.F.R. 314.
It has been clear that the FDA has had an interest in making it easier for all drug companies to update safety labeling, saying, “The [proposed final] rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements.”
The proposed final rule was originally presented in November 2013, followed by multiple public meetings and requests for comments. This final rule, if approved, would permit a sponsor of a generic drug to “immediately issue a labeling change for any safety-related change,” which would initiate a process intended to allow differences to exist between the generic drug, the brand-name reference product, and other approved generic drugs on a “temporary basis.”
The labeling change would be required to contain certain information, such as the basis for the labeling change and the available data that supports the change. Approved available data would include reliable adverse event data, published literature, or epidemiologic studies.
Pushback
While it may seem like a way for generic drug companies to better cover their assets and protect themselves against preventable lawsuits, there is a lot of pushback against the proposed rule as written.
More than 23,000 comments were submitted to the public docket, providing changes, new ideas, and voiced opinions to the proposed rule. The FDA has announced that they are considering “several alternatives” that were provided through the 23,000 comments, and are considering the financial implications and benefits that would be associated with a final rule.
Some generic drug providers were so opposed to the initial proposed rule that the generic pharmaceutical industry’s most vocal trade association, the Generic Pharmaceutical Association (GPhA) threatened to sue the FDA over the proposed final rule. The GPhA claimed that the final rule would expose its members to potentially billions of dollars in new legal liabilities. While GPhA and PhRMA “share the FDA goals to promote and protect public health,” this proposed rule “creates a scenario where disparate and potentially conflicting information from multiple manufacturers for single medicines could be widespread, causing confusion and putting patient safety, access and savings at risk.”
In the joint GPhA and PhRMA statement, both organizations say they are “pleased” that the FDA will continue to evaluate the concerns that have been expressed with the proposed rule, which would require “generic manufacturers to update labels based on incomplete information without first receiving FDA approval” because “no single manufacturer has access to the full range of available data – the proprietary data from clinical studies or the data held by each individual applicant holder.”
Patient advocacy groups, on the other hand, are eager for the FDA to finalize the proposed rule. Dr. Michael Carome, director of the Public Citizen Health Research Group, stated that, “The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients. The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”
While we are not positive of the reason for the most recent delay, one can presume that it might be a bit of additional time for the FDA to continue reviewing the suggestions offered on how to make this rule one that industry and patient advocacy groups can agree on. Both groups share the same goal of protecting patients and are hoping that the final rule will reflect that, with industry hoping few, if any, unduly and hard-to-meet burdens will be placed on them.