Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products

The Food and Drug Administration (FDA) has proposed a rule titled “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products.” The rule would require that prescribing information intended for medical professionals no longer be distributed in paper form. Instead, this information would be disseminated electronically, except in limited circumstances. FDA argues that requiring electronic dissemination of prescribing information will allow for quicker updates and improve the safety and effectiveness of prescription medications relative to the paper inserts currently employed. 

A new public interest comment by economist Todd Nesbit, written for the Mercatus Center at George Mason University, demonstrates that the proposed rule fails to show a need for the rule, fails to properly assess the benefits of the rule, and does not consider alternatives to the rule. The regulatory impact analysis should be improved to account for these failures.

Findings 

The FDA fails to establish a systemic failure indicating a need for regulatory action:

• Given that physicians and pharmacists regularly consult third-party compendia and corporately curated prescribing information, indicating that the FDA-mandated paper-form inserts are often out-of-date is not sufficient.

• The relevant questions are whether the privately provided sources of prescribing information are out of date and how frequently prescribing errors occur owing to out-of-date prescribing information.

The FDA fails to properly assess the benefits of the proposed rule:

• No attempt is made to assess the number of prescribing errors a mandatory electronic repository for prescribing information could help avoid.

• The FDA ignores the Government Accountability Office’s warning that electronic labeling fully replacing paper labeling could harm public health if it leads to limited access for some physicians, pharmacists, and patients, particularly in rural areas.

• The proposed regulation does nothing to advance toward patient-centered prescribing information and, thus, may stifle innovation since individualized information would not be offered on the repository without another rulemaking authorizing such information. This limitation diminishes the value of a centralized repository.

The FDA does not consider other relevant alternatives to the proposed regulation, a requirement of all economically significant regulatory actions as dictated in Executive Order 12866:

• The benefits of reduced printing costs are not the result of a mandated centralized repository but of removing the paper insert requirement. At a minimum, the net benefits of simply removing the paper requirement should be estimated and compared to that of the status quo and the mandatory electronic repository.

Recommendations 

Given the incomplete and flawed regulatory impact analysis, the proposed regulation should not move forward. Moreover, the regulatory impact analysis should be improved to address each of the following concerns:

• Clearly establish the regulatory need, including an estimate of the number of prescribing errors caused by out-of-date prescribing information related to paper-form inserts.

• Clearly establish the potential health benefits from a mandated electronic repository, including an estimate of the number of prescribing errors that can be avoided relative to the status quo and accounting for the usage of third-party compendia.

• Estimate the net benefits of relevant alternatives, including an option to remove the paper requirement.