The pharmaceutical printed literature industry has mobilized to block a proposed amendment that would allow electronic labeling for literature intended for healthcare professionals.
The e-labeling measure is appended at the end of House bill H.R.1919, the bill for a national drug tracing system that the full House passed on June 3.
“If Section 8. of H.R. 1919 is not eliminated, FDA approved printed package insert labeling of dangerous prescription drugs will be stopped and we will lose a dual system of communication that uses both printed labeling and online information sources,” the Pharmaceutical Printed Literature Association (PPLA) said in a briefing sheet.
The proposed regulation does not apply to patient literature such as MedGuides and other inserts for patients supplied with packaging but rather to the professional package insert (PI) required of manufacturers for drugs in distribution.
However, patients often ask for the PI to get informed about their prescribed medications, says Robin Henfling, strategic development director, Chesapeake Pharmaceutical and Healthcare Packaging, and the PPLA’s chairman.
“Many patients rely on the professional leaflets. This is critical information written by the manufacturer in standard format with content and language approved by FDA. (The PI) is written for the professional but many parts of it are accessible to the layman,” Henfling says.
Drug information printed by pharmacies—which has a low rate of adherence to government-required criteria—provides patients with a poor alternative, PPLA says.
PPLA has mounted a sustained lobbying effort against the e-labeling amendment, arguing:
--Electronic information is subject to random and unexpected disruption whereas printed materials are always readily available with the drug in any environment to provide proper instruction. Internet access is not available in all locations. Also, a single source of electronic information is subject to hacker mischief.
--the printed literature is relied upon by both healthcare providers and patients.
--Section 8 would put the professional insert printing industry out of business at a cost of 10,000 jobs permanently lost. The specialty presses and related equipment used by suppliers cannot be adapted for other business.
--Additionally, the attempt at an e-labeling amendment is premature. Tasked by last year’s PDUFA legislation, the Government Accounting Office (GAO) is now studying the e-labeling issue with study results due to be released by July 2013.
“Why would the House want to eliminate paper labeling in favor of electronic labeling before the GAO study it chartered on this specific issue is complete? That makes no sense,” PPLA said.
If the Senate’s proposed traceability law passes in the full Senate as expected, the Senate and House will attempt by conference committee or other means to reach a consensus on a single bill, subsequently to be voted on by both houses.
“We have talked with many people in the Senate who support the Senate’s version of the tracing law. Senators we have talked with acknowledge the (electronic labeling amendment) doesn’t belong in there,” says Henfling.
Section 8 of the House bill reads as follows:
In General- Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) is amended by adding at the end the following new sentence: ‘Required labeling (other than immediate container or carton labels) that is intended for use by a physician, a pharmacist, or another health care professional, and that provides directions for human use of a drug subject to section 503(b)(1), may (except as necessary to mitigate a safety risk, as specified by the Secretary in regulation) be made available by electronic means instead of paper form, provided that such labeling complies with all applicable requirements of law, the manufacturer or distributor, as applicable, affords health care professionals and authorized dispensers (as defined in section 581) the opportunity to request the labeling in paper form, and after such a request the manufacturer or distributor promptly provides the requested information without additional cost.
- Dave Vaczek