On December 18, 2014, FDA released proposed regulations that would make prescribing information for drugs and biologics available online and prohibit distribution of paper copies as part of product packaging. FDA’s stated goal is to make prescribing information widely and easily accessible to healthcare providers and consumers alike, but some consumer and provider groups are criticizing the proposed rules because they may limit access to prescribing information in communities where the Internet is not readily available. The proposed rules also go against Senate Appropriations Committee directions to FDA to “ensure that any proposed regulation regarding electronic inserts does not come in lieu of paper inserts.” The generic drug industry, however, has applauded the rule as a viable alternative to a separate proposal requiring unilaterally updated labeling for generics and brand-name products.
The proposed rules would require manufacturers of prescription drugs and biologics, including blood and blood components for transfusion, to submit prescribing information for FDA to post on its online database, labels.fda.gov. Prescribing information, also known as “professional labeling” or the “package insert,” is meant to convey the most current information on product safety and effectiveness to healthcare providers and pharmacists. The electronic format would replace the written form which currently comes attached to a product’s packaging. The product’s immediate container and outside packaging would need only to include a written statement directing providers to labels.fda.gov, as well as a toll-free telephone number to request the prescribing information by fax, email, or mail.
Under the proposed rules, manufacturers (including repackagers and relabelers) would also be required to send prescribing information to FDA at various times. First, the manufacturer must submit initial prescribing information before the product goes on the market. Then, the manufacturer would be required to notify FDA within two days of making any change to the prescribing information once the product is commercially available.
FDA emphasizes that the posted information must be accurate, but the proposed rules would place the burden of verification on manufacturers. A manufacturer would be required to notify FDA within four days of submitting prescribing information if the information is not posted within that time. However, if FDA posts incorrect prescribing information, the manufacturer would be required to notify FDA of any errors within two days. According to the proposed rule, failure to meet the notice requirements may result in FDA enforcement action for misbranding. FDA has specifically requested comments on whether the proposed rules give manufacturers enough time to verify the accuracy and completeness of the posted prescribing information.
While the proposed ruled would significantly impact product prescribing information, FDA has not explained how consistency of the information will be maintained. For instance, even though the generic drug industry is touting the proposed rules as an alternative to the proposed generic drug labeling rule, the rules do not account for labeling variations between drugs and biologics of the same type or class. If one generic drug manufacturer changes the prescribing information for a drug, must other generic manufacturers follow? Must the reference drug manufacturer? The potential for encountering conflicting prescribing information in FDA’s database exists not only for generics but also for products in a therapeutic class where changes in the prescribing information may pertain to the mode of action rather than the molecular entity. FDA should explain how it will minimize these inconsistencies.
The proposed regulations would affect not only manufacturers, who must develop and monitor the online prescribing information, but also healthcare providers and pharmacists, who must make regular use of the prescribing information. Comments on the proposed regulations may be submitted to Regulations.gov and are due by March 18, 2015. We encourage all stakeholders to submit to FDA comments describing how the proposed regulations will affect their business.