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Posted 25 March 2015 | By Alexander Gaffney, RAC

FDA's Electronic Drug Labeling Proposal Comes Under Fire


The US Food and Drug Administration (FDA) is coming under fire from patient safety groups and US legislators who say the agency's attempt to require certain drug labeling information to be distributed electronically instead of on paper "package inserts" could put patients at risk.


In December 2014, FDA released a long-anticipated proposed regulation, Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, otherwise known as FDA's "electronic drug labeling rule."

The intent of the rule is relatively straightforward.

Prescription drugs are often accompanied by a long list of warnings, side effects, contraindications and other relevant information. Such information is of great importance to prescribers, who must know if a patient is likely to benefit or be harmed by a medication. To convey the risks and benefits of a drug to prescribers, FDA requires drug manufacturers to include a package insert with their products containing all relevant information.

But there's a potential problem: Because drug products can sit on shelves for months—even years—before being prescribed to a patient, the paper package insert often does not contain the most up-to-date information about a drug's benefits and risks. That could leave patients at risk

And then there's the cost. In 2013, US patients filled 3.9 billion prescriptions for prescription drugs at retail pharmacies. The number of package inserts that must be printed has given rise to a multimillion-dollar industry, complete with its own advocacy organization.

Pharmaceutical companies, meanwhile, have long argued they should be allowed to distribute drug labeling electronically.

"The time is right to transition to electronic distribution of prescribing information from the static, potentially outdated paper version on pharmacy shelves and in warehouse to having the most up-to-date information available electronically through a publicly available label repository," Novartis said in its

cumentDetail;D=FDA-2007-N-0363-0062">comments on FDA on the rule.

FDA's Proposed Rule

FDA's proposed regulation would do just that: require drugmakers to distribute their prescribing information in an electronic format. Companies would be barred from distributing information in paper form, FDA said.

FDA said it hoped its proposal would "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."

The electronic requirements do not apply to patient labeling, including package inserts and medication guides, or promotional labeling—only to the drug's "professional labeling."

The rule requires a product’s "immediate container label and outside package to bear a statement directing health care professionals to FDA’s labeling repository to view the electronic version of prescribing information."

Under the system, product manufacturers will be required to update the product labeling at FDA's website "every time there is a change in the labeling." They would also be required to verify that the correct labeling is posted on FDA's website, the agency said, and to "promptly notify" the agency if it is not.

Manufacturers would also be required to set up a 24-7 toll-free number where healthcare professionals could request paper copies of the prescribing information. This, FDA said, would ensure that persons without Internet access—such as in an emergency or power outage—could still access prescribing information.

Negative Reactions

The proposed rule has been met with a considerable amount of criticism.

Some safety groups, including the Institute for Safe Medication Practices (ISMP), have called the proposal unworkable in its current format.

"It is clear to us that the label repository website,, is not ready to use for locating drug information," ISMP wrote in a letter to FDA. "As described below, the system is deeply flawed and will almost certainly lead to harmful or fatal medication errors." The group said the current website is onerous to use and requires users "to sift through numerous pages to locate the actual drug information that they are seeking."

Another concern, noted in many comments to FDA, is that the electronic prescribing rule would impact the way in which physicians interact with and treat their patients. Many physicians will mark up the prescribing information for the patients, some comments said. ISMP noted that physicians frequently reference the printed materials, and that changes could lead to "workflow disruptions," and even delay care during an emergency.

Faced with a large amount of interest in the proposed rule, on 9 March 2015 FDA announced it would extend the comment period for the proposal until 18 May 2015.

Congressional Interest

But companies aren't the only ones interested in FDA's electronic labeling rule, and that could spell trouble for the agency moving forward.

At least five US legislators—Sens. Susan Collins (R-ME) and Angus King (I-ME), and Reps. Bruce Poliquin (R-ME), Gregory Meeks (D-NY) and Thomas Massie (R-KY)—have all written to FDA expressing their concern about the proposed rule.

“Pharmaceutical paper inserts are an important tool for our pharmacists and health care professionals that are in charge of administering life-saving medications to our hardworking families and seniors,” Collins, King and Poliquin said in a joint statement. The trio say they are working "to press FDA to reconsider and withdraw this harmful proposed rule.”

Like the Maine legislators, Rep. Massie expressed his concern that the proposed rule could harm constituents in rural areas where Internet access is poor.

The broad interest in the electronic prescribing rule could put pressure on FDA, which is currently the subject of reform legislation in both the House of Representatives and Senate. Increased interest in the proposed rule just as legislators are working on FDA reforms could raise the chance that statutory changes are made to FDA's labeling regulations.

Whether FDA will succumb to pressure or hold fast to the intent of its proposed rule remains to be seen.



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