FDA's proposed rule on labeling requirements for systemic antimicrobials should allow for "appropriate treatment" of infections that are suspected to be caused by susceptible microorganisms, the Pharmaceutical Research & Manufacturers of America said in comments to the agency.

The proposed rule states that "antibacterial drug products should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms" (¹ Also see "FDA Considering Exclusivity Program As Antimicrobial Development Incentive" - Pink Sheet, 25 September, 2000.).

FDA's proposed statement overlooks situations when physicians rely on experience to prescribe antimicrobial therapy due to the absence of susceptibility data and rapid diagnostic tests at the point of care, PhRMA suggested.

FDA should defer to the physician's expertise to decide appropriate use, PhRMA said. "Clinical practice and the experience of the physician provide the clearest rationale for prescribing practice and the use of this knowledge does not constitute 'inappropriate use.'"

Labeling language should note that "when microbiological data are not available for an individual patient, the decision to prescribe an antibiotic should be based on the clinician's assessment of the most likely etiology and optimal therapy," the comments state.

The assessment may come from "available clinical, pharmacodynamic and in vitro information provided from clinical trials and postmarket experience with antimicrobial agents," PhRMA said.

The association argued that cost containment measures and lack of infrastructure limit the ability to perform susceptibility tests at the primary care level.

"Currently, there are no rapid diagnostic tests available at most points of care that will reliably distinguish viral from bacterial infections, or distinguish susceptible from resistant bacterial pathogens," the comments note.

"The infrastructure required to support diagnostic testing in primary care settings is currently not in place and is unlikely to be funded without data to support the cost-effectiveness of having culture and susceptibility data to guide antimicrobial therapy," PhRMA said.

PhRMA suggested FDA delay implementing the proposed rule until complete implementation of the Interagency Task Force on Antimicrobial Resistance's action plan (² Also see "Antimicrobial Drug Approval May Be Speeded By Enhanced Preclinical Studies" - Pink Sheet, 22 January, 2001.).

Any delays in the action plan, which establishes action items to be implemented over five years beginning in June 2000 to reach specific surveillance, prevention and control goals, could impact implementation of the proposed antibacterial labeling, PhRMA said.

PhRMA also proposed that "inappropriate use" information for antimicrobials would be better placed in the precautions section rather than at the beginning of the label, as proposed in the draft rule.

The placement of an inappropriate use statement immediately below the product name, which is "the most important location of the label," PhRMA said, would imply that "these statements provide the most important information about the product to merit this prominence both in labeling and as part of the fair balance information in promotional labeling."

Instead of placing general statements on inappropriate use in the area immediately under the product name, FDA should reserve that section of labeling for important safety warnings such as boxed warnings as per current regulation, PhRMA said.

Pharmacia's comments argued that since the proposed statements are well known to physicians, "the use of standard labeling statements regarding medical practice is likely to make physicians skip those paragraphs when reading a package insert."

"Product labeling should not dictate medical practice," Pharmacia said.

The Alliance for the Prudent Use of Antibiotics and the Society of Infectious Diseases Pharmacists requested in their comments on the draft that the final regulations be extended to clarithromycin (Abbott's Biaxin) and rifampin, which would be excluded under the proposal.

Otic, ophthalmic and topical antimicrobial agents, rather than only systemic products, should also be included, SIDP suggested.

Antimicrobials Labeling Rule Should Allow "Appropriate Use," PhRMA Says

More from Archive

More from Pink Sheet