Well, after a lot of talk and years of discussion, “The Food and Drug Administration (FDA) is proposing to amend its labeling regulations at 21 CFR 201.100, 201.306, 201.310, 606.121, 606.122, 610.60, and 610.61 for human prescription drugs and biological products, and blood and blood components intended for transfusion, to require that the prescribing information (commonly referred to as the package insert) intended for health care professionals be distributed electronically and, with few exceptions, not in paper form.” A full copy (81 pages) of the proposed regulation can be found here. This Rule also will apply to manufacturers and distributors of unapproved marketed prescription drug products.
The Proposed Rule notes: “The paper form of the prescribing information may not contain the most current information because it may have been printed and distributed prior to more recent labeling changes, while the electronic form of prescribing information can be updated in real-time. FDA is taking this action to ensure that the most current prescribing information for prescription drugs will be available and readily accessible to health care professionals at the time of clinical decision making and dispensing.” In addition, the paper copies are not often available to healthcare providers as they usually do not dispense drugs, and pharmacies often just throw the paper inserts away when the product is dispensed, especially if the drug is dispensed in something besides the original container. FDA typically does not require recalls of product in commerce to update labeling and, as a result, it may take months before the most current version of a paper label reached the target audience. Electronically available label updates can be made available almost immediately.
The electronic distribution requirements of this Proposed Rule would not apply to patient labeling (including patient package inserts and Medication Guides), or to prescribing information accompanying promotional labeling, which would continue to be provided in paper form.
“Manufacturers would be required to submit the prescribing information to FDA for posting on FDA’s publicly available labeling repository Web site (labels.fda.gov) every time there is a change in the labeling. FDA would require firms to provide notice on the package label of the availability of the web site and direct healthcare providers to access that cite for current labeling.” Note that there is an exemption for certain biologic products relative to the label statement. The Rule also is requiring the inclusion of a toll free number on the product label that must be available 24 hours a day 7 days a week to assure that the information is readily accessible if internet access is not available to a healthcare practitioner. FDA notes that it also participates in the DailyMed web site, which provides publically available structured product labeling through the National Library of Medicine.
Given the time necessary for industry to make the preparations that are needed to comply with this regulation, FDA is proposing an effective date of 6 months after the publication date of the Final Rule in the Federal Register and a compliance date of 2 years after the date of publication of the Final Rule.
FDA is proposing that for label changes requiring a prior approval supplement that those changes be posted with 2 days of the FDA approval. Labeling changes submitted to FDA in Changes Being Effected (CBE) supplements or to be updated in Annual Reports (AR) should be submitted to FDA at the time of submission of the CBE supplement or when the change is made for an anticipated later AR filing. FDA will also require the submitter to check the labeling once posted to the FDA site to be certain that it is accurate and complete and represents the most accurate and up-to-date label copy.
The proposal will save firms millions of dollars in label changes and discarded out-of-date labeling while providing the most accurate up-to-date labeling to the healthcare provider. From a legal perspective, this could open up a new can of worms by plaintiff’s attorneys chasing down dates of updates for potential failure-to-warn law suits. If the innovator changes its label today and it shows up on the FDA site tomorrow, but it takes the generics 2 weeks to see the updates, then what happens if a patient gets injured in that window before the generic has time to change its label? FDA should build a mechanism to search by date updated and provide a notice of any change with the date that change was made such that it is readily available to the industry. What happens when a generic company fails to provide labeling in accordance within the timeframe permitted by the new FDA regulations, and how will enforcement actions (e.g., misbranding) be administered by the Agency? Resolving incorrect postings or failure of the FDA to post (e.g., computer glitch) must also be dealt with in finalizing the regulations.
While there is a process for requesting exemptions from the electronic labeling rule, it is expected that such exemptions will be rare. The comments on the Rule will be very telling as to how the public and the industry view this major transformation of labeling requirements. In addition, it is good to know that the FDA labeling site referenced above is already available on line. I tried it and it actually works and is easy to use. This is a good start, but we will have to see how it dovetails with any final action the Agency takes on the Generic Drug Labeling Rule expected to be finalized in late 2015.
