Specific Questions From FDA

1) FDA is seeking to foster innovation in the use of digital technology with prescription drugs while maintaining a consistent approach to communications by sponsors about their drugs. Does the proposed approach to prescription drug-use-related software adequately foster innovation by drug sponsors?

2) What alternative regulatory approaches could the Agency consider?

3) What should FDA take into consideration with respect to applying prescription drug labeling requirements in this context (e.g., the requirement that labeling bear adequate directions for use)? Does the proposed approach adequately preserve FDA's ability to ensure that existing prescription drug labeling requirements are met?

4) In a situation where the output of prescription drug-use-related software includes a benefit claim about the drug, what should FDA consider when providing recommendations on how to appropriately address the balancing of benefit information and risk information?

5) Does the proposed framework appropriately characterize the types of prescription drug-use-related software output that should be submitted for advisory comment? Are there other examples for which advisory comment should be recommended because there is a strong potential that the prescription drug-use-related software output will increase the potential for harm to health if used with a drug?

6) Does the proposed framework appropriately identify the materials and information that should be submitted by drug sponsors as part of a voluntary request for comment under § 202.1(j)(4)? Are there other materials or information FDA should consider in its evaluation of whether prescription drug-use-related software output submitted by drug sponsors is consistent with FDA-required labeling and is truthful and not misleading (e.g., human factors study results)?

7) Regarding software functions, FDA's proposed expectation is that sponsors are responsible for ensuring that prescription drug-use-related software reliably produces its output as intended. Is this approach sufficient to ensure patient safety?

8) FDA recognizes that software will have frequent updates, many of which will not alter prescription drug-use-related software functionality. FDA proposes that for prescription drug-use-software output that is considered promotional, if changes in the software do not alter the output experienced by the user, FDA would not need to be notified of those changes. Does this approach strike an appropriate balance between allowing for software innovation while providing adequate oversight of sponsor communications about their prescription drugs?

9) What can be done to ensure that the end user has access to the prescription drug-use-related software that is appropriate to the specific drug dispensed at the pharmacy (e.g., in cases of generic substitution)?

10) What issues should the Agency consider as it develops this proposed framework in order to facilitate timely generic competition for prescription drugs that are approved with prescription drug-use-related software output included in the FDA-required labeling?

Drug/Software Combos Likely Won't Require Pre-Market Review By US FDA

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