FDA Denies Citizen Petition Seeking Mandatory NDA Labeling for Prescription Drugs
On January 6, 2012, the U.S. Food and Drug Administration (“FDA”) denied a citizen petition (Docket No. FDA-2008-P-0291) requesting the FDA to require manufacturers and distributors of prescription drug products to include the new drug application (“NDA”) number on drug product labels.
PRN Publishing, a company that distributes a monthly newsletter for community pharmacists, filed this citizen petition in 2008 over concerns about pharmacists ability to determine the equivalency status of prescription drug products. (See the full text of PRNs citizen petition here.) When filling prescriptions, pharmacists often refer to the list of Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, to determine the equivalence status of brand and generic drug products in the United States. Where substitution is not prohibited by a prescriber, pharmacists have a duty to dispense only those generic products which appear in the Orange Book and are rated “A.” The citizen petition argued that, due to frequent changes in drug manufacturers and distributors of particular drugs, pharmacists may have difficulty matching drug products on the shelves with the corresponding listing in the Orange Book. As a solution, PRN suggested that all prescription drug manufacturers and distributors should include a drug products NDA number on the label of each bottle. Thus, this system would allow pharmacists “to quickly and easily determine the equivalence status of any drug product by simply comparing the NDA number on the bottle to the NDA numbers listed in the Orange Book under the heading of the particular drug in question.”
Currently, 21 C.F.R. part 314 requires that all drug manufacturers obtain FDA approval of a drug application in order to market a new drug or generic drug. Manufacturers and distributors, however, are not required to place this approved application number on drug product labels. Section 10.30 of the Code of Federal Regulations provides citizens the opportunity to submit a petition to the FDA requesting the Agency to add, remove, or change its regulations. (See 21 C.F.R. § 10.30.) In its citizen petition, PRN suggested that the change to Agency requirements would benefit all stakeholders because it would 1) protect patients from inadvertent illegal substitution; 2) relieve pharmacists of the undue burden of having to research the provenance of each drug product before dispensing generics; and 3) guarantee drug makers that a companys NDA is “firmly attached to its product in whatever form it is distributed.”
Upon reviewing this citizen petition, the FDA did not find PRNs recommendation to be an effective means of communicating drug equivalence to pharmacists. (See the full text of FDA denial here.) In its denial, the FDA pointed out that authorized generic drugs share the same NDA numbers as the branded innovator product and would not be identified separately from the branded drug in the Orange Book. The FDA addressed this issue in the introductory section of the 28th edition of the Orange Book. There, the FDA specifically indicated that distributors and repackagers of products in the Orange book are not identified “because [they] are not required to notify FDA when they shift their sources of supply from one approved manufacturer to another.” Consequently, “it is not possible to maintain complete information linking product approval with the distributor or repackager handling the product.”
Further, the FDA asserts that PRNs recommendation may result in confusion because “[p]harmacists could be confused when they look up an NDA number in the Orange Book and find only a listing for the innovator product.” The FDA noted that the citizen petition lacked sufficient data or information to support the claims listed. After balancing PRNs claims against the Agencys statutory mandate, space limitations, alternatives, potential for confusion, and potential safety risk, the FDA concluded that it would not be necessary to amend the current drug labeling requirements at this time and denied PRNs citizen petition.
Fuerst Ittleman will continue to monitor the developments in the regulation of drug products. For more information, please contact us at email@example.com.