FDA Proposes Rule To Require Electronic Rx Drug Labeling
December 22, 2014 in News
On Thursday, FDA published a proposed rule in the Federal Register that would replace paper prescription drug-labeling information for health care providers with an electronic system, Bloomberg reports.
Currently, information about the safety and effectiveness of prescription drugs is distributed to health care providers in paper form.
FDA says that under the paper format, information can become outdated if it is printed and distributed before labeling changes are made. However, the agency says that an electronic form of prescribing information could be updated in “real-time,” giving providers access to the most current prescribing data.
Details of the Proposed Rule
Under the proposed rule, drugmakers would be required to:
- Send FDA prescribing data when labeling information changes so the agency can update its public labeling website;
- Review and verify information on the site is correct; and
- Notify FDA promptly if information on the site is incorrect.
In addition, the law would require prescription drug containers and outside packages to include:
- Language directing prescribers to FDA’s labeling site to view prescribing information; and
- A toll-free phone number — accessible 24 hours a day, seven days a week — at which the drug manufacturer can receive requests for paper copies of prescribing information.
The proposal would allow FDA to exempt agencies from complying when doing so would adversely affect safety, effectiveness, purity or potency of a drug, or when it is not technologically possible or inappropriate (Mixter, Bloomberg, 12/17).
FDA said the proposed rule would not affect printed drug information and prescription instructions for consumers.
The agency estimates the change would save the drug industry $52 million to $164 million (Jenks, “Healthopolis,” CQ Roll Call, 12/18).
The proposed rule will be available for comment until March 18 (Bloomberg, 12/17).