Proposed Generic Labeling Rule Would Cause Confusion, Industry Group's Study Says

The FDA’s proposed rule that would allow generic manufacturers to alter generic drug labels without FDA approval would cause confusion for patients and providers, show the results of a Farleigh Dickinson University PublicMind survey. In addition, many health care providers, including physicians, physician assistants, and pharmacists, said they were not aware of the proposed rule, the results suggest. The survey was conducted on behalf of the Generic Pharmaceutical Association.

The rule, which the FDA proposed in November 2013, would allow generic drug manufacturers to modify drug safety labels once they receive new drug safety information, and in advance of FDA review.

The FDA introduced the rule following the Supreme Court’s decision in a high-profile case regarding liability claims and generic drug safety labels. The court determined that generic drug manufacturers could not be held responsible for failing to warn patients about postmarket safety changes, because generic manufacturers must reproduce the originator’s product label exactly, and cannot change the labels without FDA approval.

Since introduction of the proposed rule, various patient advocacy, disability, veterans, minority, and provider groups have expressed concerns about it. Many of the concerns relate to labeling consistency and patient safety, because the changes could result in multiple versions of product labels.

Most of the providers participating in the survey felt that many different labels for the same product would confuse patients. Only 23% of pharmacists surveyed felt that multiple labels would have no impact on patient confusion; 37% felt there would be a great impact on patient confusion. An additional 37% of pharmacists felt that multiple labels would have some impact on patient confusion.

Overall, providers felt that existing information about generic drugs is adequate, with 95% of pharmacists surveyed saying generic drug information is sufficient.

Many pharmacists (93%) thought access to safety data should be required prior to changing generic product safety labels. Meanwhile, 87% of pharmacists felt that FDA approval should be required before changes are made to any safety labels.

Pharmacists were most likely to say they would be very concerned about the legal liabilities accompanying the label changes—53% of pharmacist participants said potential legal liabilities would concern them “a lot,” and an additional 32% said legal liabilities would concern them “some.”

Most pharmacists surveyed by Farleigh Dickinson University’s PublicMind said multiple drug labels would be confusing, with 51% stating that it would be very confusing, and 39% that it would be somewhat confusing. In addition, most pharmacists did not feel they would have the time necessary to keep up with labeling changes.

“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” said Thomas E. Menighan, executive vice president and chief executive officer of the American Pharmacists Association. “Pharmacists devote a great deal of time to counseling patients on appropriate medication use, and as the survey indicates, 67% of pharmacists asked are concerned that they will not have sufficient time to effectively address issues created by this proposed regulation.”