Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”).  Currently, although manufacturers often voluntarily make their product PIs available electronically, they are required to distribute the PI in paper form on or within the package from which a prescription drug or biological product is dispensed.  However, under the Proposed Rule, manufacturers would be prohibited from distributing the PIs in paper form, except under limited circumstances. The Proposed Rule is expected to be published in the Federal Register on December 18, 2014, and written or electronic comments from the public will be accepted until 90 days after the date of Federal Register publication (expected to be March 18, 2015).

The FDA has expressed concern that the paper form of the PI “may not contain the most current information because it may have been printed and distributed prior to more recent labeling changes.”  Alternatively, the FDA believes that the electronic form of the PI “can be updated in real-time” and thus “FDA is taking this action to ensure that the most current PI for prescription drugs will be available and readily accessible to health care professionals at the time of clinical decisionmaking and dispensing.”  Manufacturers would be required to submit electronic PIs for publication on the FDA’s publicly available labeling repository at every time there is a labeling change. In addition, manufacturers would be required to review the online labeling to verify it is the correct version.

If finalized, the Proposed Rule would apply to PIs distributed in paper form on or within the package from which the drug is to be dispensed.  “Paper” PIs would still need to be available via e-mail, fax, or mail, upon request to a manufacturer-maintained toll-free telephone number.  In addition, there would be an FDA exception process for certain limited situations (e.g., for products intended for use in an emergency room or a product that may be stockpiled for an emergency).  The Proposed Rule would not apply to any patient labeling, such as patient package inserts or medication guides.  In addition, the Proposed Rule would not apply to PIs accompanying promotional labeling under 21 C.F.R. § 202.1(I)(2).

The FDA proposes that the regulations, if finalized, would have a compliance date of two years after the final rule is published. However, the FDA proposes that a product distributed between the effective date and the compliance date that bears the new required statement on the label and outer container must have the current electronic PI in the repository and should not be accompanied by the paper PI. The FDA indicates that the final regulation “may include staggered compliance dates, with a later compliance date for blood and blood components and an earlier compliance date for all other drug products.”

While all comments will be accepted, the FDA specifically invites comments:

  • on whether blood and blood components intended for transfusion should be subject to the electronic distribution of PI requirements in the Proposed Rule once the electronic submission standards accommodate these products;
  • from public health authorities and the medical care community on how product labeling is currently handled and whether current practices are sufficient when Internet access is not available due to disasters or public health emergencies;
  • on what impact, if any, the Proposed Rule will have during a public health emergency, natural disaster, or other situation involving field response when Internet or wireless access is not available or reliable;
  • on whether the proposed exemptions provision provides emergency planners with sufficient flexibility regarding the labeling of their stockpiled products;
  • on ease of use of the Web site;
  • on other categories by which the repository should be searchable (it is currently searchable by proprietary name, active ingredient, company name, NDC number, and application number or regulatory citation);
  • on whether requesting the PI over the telephone is a sufficient method for obtaining it when it cannot be accessed using the Internet;
  • on what would be considered a reasonable amount of time to respond to a request for current PI (the proposed requirement is to “promptly” respond);
  • on alternative or additional methods for ensuring that health care professionals without regular Internet access have the most current PI;
  • on whether the existence of two different formats of electronic labeling (e.g., labels subject to the FDA’s 2006 labeling rule, and those not) would present barriers to their value when used in the health care setting;
  • on whether a conforming amendment cross-referencing 21 C.F.R. § 201.100 should be added to 21 C.F.R. § 314.97 (which addresses the requirements for submitting supplemental applications and other changes to an approved abbreviated application);
  • on the feasibility of the application of electronic distribution of PIs for cellular therapy products regulated under section 351 of the Public Health Service Act;
  • on the availability of the biologic product container package in cases where the immediate container label does not have adequate space for the required 6-point typeface statement (e.g., to obtain the current PI, go to or call (insert the toll-free telephone number) for a faxed emailed, or mailed copy)
  • on the feasibility of requiring a statement of this length on containers such as small volume single dose vials and syringes of product, some of which already bear one or more peel-off labels for product identification and inclusion in patient charts; and
  • on whether the proposed review timeframes provide a sufficient amount of time for a manufacturer or applicant to check the accuracy and completeness of the posted PI.

In addition, the FDA also describes and requests comments on two possible “dual systems” – one possible system under which the electronic PI would be required, but that would permit voluntary distribution of the paper version, and another possible system under which the electronic PI would be required, but where dispensers (e.g., pharmacies) would have the option of ordering single or multiple copies of the paper PI when ordering a shipment of drug from the distributor.  Finally, the FDA broadly solicits “any additional comments on the use of prescribing information by prescribers and other health care professionals, as well as consumers/patients.”

In reviewing the Proposed Rule, manufacturers should consider whether any operational challenges might be presented in compliance.  Among other things, manufacturers should consider whether it may be necessary to: (1) update contracts with third parties involved in producing and/or distributing products and/or labeling, (2) update previously approved materials, (3) update policies and procedures (e.g., for trade and packaging), (4) implement/update “24/7” customer service call-line, scripts, contracts and policies to address requests for “paper” PIs, and (5) assign specific responsibility for reviewing online labeling, updating training etc.

Posted by Kathleen Peterson

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