Additional Tidbits from the Proposed ANDA / 505(b)(2) Rule and Oops! A Correction

Please note that in our February 23 post (which has since been corrected), we inadvertently left out two words that make all the difference in the meaning of the concept.  So, if you only read the post prior to the correction we wanted to clarify the change.   The sentence of concern in the section on the Further Definition of Listed Drug should have read (the two previously missing words are bolded):

FDA is proposing to clarify that the definition of Listed Drug includes a drug product in the discontinued section of the Orange Book, which was suspended, withdrawn or otherwise discontinued from sale for other than safety or efficacy reasons.

Here are some more tidbits gleaned from the Proposed Rule.

Clarifying “Strength” of Parenteral Product

“FDA has a longstanding history of considering a difference in the total quantity of drug substance of a parenteral product (e.g., a single or multiple dose vial) or a difference in the concentration of a parenteral product to be a difference in the “strength” of the product for purposes of section 505(j)(2)(A)(iii) of the FD&C Act. FDA considers it important to review proposed differences in the total drug content or the concentration of a parenteral product because such changes can result in medication errors and incorrect dosing of patients.”  Thus, strength for a parenteral product will be judged by the total drug content in the container and the concentration of the drug substance.

Tentative Approval

FDA plans to define a tentative approval as an application that meets all FDA regulatory requirements and is otherwise approvable, but cannot be approved due to the existence of a period of patent or exclusivity protection.  FDA expands this definition to include 505(b)(2) applications and confirms that a tentative approval does not mean the application is approved until a final approval letter is issued by the Agency.

Identification of Labeling That Claims Method of Use  

FDA recognizes that method of use claims may apply to areas of labeling other than the “Indications for Use” section of the label, and is clarifying that NDA holders must identify which specific sections of the label pertain to the claims of the patent.  FDA believes that “[T]his information regarding product labeling also is necessary for FDA to evaluate whether the omission of aspects of the listed drug’s labeling protected by patent would render the proposed drug product less safe or effective than the listed drug for all remaining non-protected conditions of use and preclude approval.”  This is a concept that innovators love to assert when a proposed label carve-out is proposed by a generic.

Stay tuned for more on this important Proposed Rule!