Drugs

Suggestions to Improve OTC Drug Draft Reg

David McFarland

— 2 min read
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Several stakeholders are suggesting ways they believe an FDA draft regulation on nonprescription drug products with an additional condition for nonprescription use (ACNU) can be improved. Public Citizen Health Research Group says concerns raised by stakeholders in countries in which pharmacists enable patients to get medicines without a doctor’s prescription highlight several problems with implementing such a system in the U.S. The comment letter identifies the problems as limited pharmacist diagnostic skills, lack of access to patient clinical records, accountability for prescribing, the not unlikely shifting of cost from insurers to patients, and the extra costs of additional training for pharmacists as well as reimbursement for additional time.

Pharmaceutical Research and Manufacturers of America identifies areas of the proposed rule that it says would benefit from further discussion:

  • FDA, not the applicant, should be required to determine whether an ACNU is necessary, and the final rule should clarify the applicant content requirements on the operationalization of the ACNU;
  • FDA should allow applicants to seek approval of ACNU products by submitting a supplement to an approved NDA when doing so would be consistent with the law;
  • FDA should streamline the proposed rule’s postmarket reporting requirements;
  • FDA should recognize that ACNU are conditions of use under section 505(j) of the Federal Food, Drug, and Cosmetic Act; and
  • ACNU should be eligible for patent listing if they meet the criteria outlined in the law and FDA’s patent listing regulations.

The Consumer Healthcare Products Association says it agrees with many of the principles outlined in the proposed rule and offers feedback in three areas: general feedback, recommended changes to the proposed regulations; and the favorable economic impacts of the proposed rule will be undermined if simultaneous marketing remains in the rule.

The Association for Accessible Medicines says it is important for FDA to ensure that the ACNU pathway is a viable option for generic firms by:

  • providing more examples of the types of products that could be marketed under the pathway;
  • articulating in the final rule the principle that brand companies cannot use proprietary ACNU conditions to block generic competition and providing more examples of allowable operational differences;
  • providing additional information regarding exclusivity and patent listings;
  • providing more detail on how FDA expects the new pathway to be implemented through the nationwide distribution and dispensing supply chain;
  • eliminating burdensome postmarketing reporting requirements;
  • providing examples of allowable differences in labeling between brand and generic drugs with ACNUs and simplifying the labeling statements required on products with ACNUs; and
  • providing more detail on FDA’s processes for handling members of a class of drugs after the first drug switches to a nonprescription product with an ACNU.

Finally, the National Association of Chain Drug Stores recommends that FDA rework the proposed rule to establish these labeling requirements for nonprescription drug products with an ACNU:

  • nonprescription drug products with an ACNU should be made available to patients only at state-licensed pharmacies where licensed pharmacists can assist with the necessary patient assessment processes for determining whether a particular medication is appropriate for the individual; and
  • FDA should require that ACNU processes (e.g., patient assessment processes, recordkeeping) be standardized and aligned with other current requirements related to dispensing.

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