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ASHP Comments on FDA Guidance on OTC Transition Approvals

Food and Drug Administration

September 17, 2018

[Submitted electronically to]
Dockets Management Staff (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA–2018–D–2281 for “Innovative Approaches for Nonprescription Drug Products; Draft Guidance for Industry; Availability.”

ASHP is pleased to submit comments to the Food and Drug Administration (FDA) on the draft guidance regarding innovative approaches for demonstrating safety and effectiveness for a nonprescription drug when the drug facts labeling (DFL) alone is insufficient. The organization’s 45,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety. ASHP thanks FDA for the opportunity to comment on the draft guidance. We hope that our feedback will assist FDA in assessing DFL sufficiency and imposing appropriate conditions to ensure safe consumer use of over-the-counter (OTC) medications.

  • Additional Conditions for Safe Use: ASHP recognizes that the draft guidance is meant to provide basic examples of conditions for safe use rather than an exhaustive list. However, as ASHP has commented in the past regarding OTC status approval, actual-use studies should be required for all therapies that may be available without a prescription, just as these studies are required for products moving from prescription to nonprescription status. Additionally, pre-approval clinical studies and systematic data collection from postmarketing surveillance should play a critical role in assessing whether a product is appropriate for OTC status. ASHP recommends that a drug’s continued nonprescription status be assessed based on data from postmarketing surveillance, epidemiological studies, and adverse event reporting. Post-marketing surveillance of these medications should include collaboration between FDA and the product manufacturer and should be supported by information reported by pharmacists and patients to an established surveillance system, such as MedWatch. Based on this information, products might be reassigned to prescription or OTC status.

  • OTC Medications for Chronic Conditions: In general, ASHP supports approval of products for OTC status provided there is evidence that consumers can use the products safely and effectively. However, we caution that certain medications may not be suitable for OTC status unless the conditions of use are stricter than the self-selection tests or the knowledge affirmation examples in the guidance. Specifically, FDA notes that enhanced DFL and/or additional conditions of use “could lead to the approval of a wider range of nonprescription drug products, including drug products that may treat chronic conditions.” Certain medications for chronic conditions require greater clinical oversight and expertise and closer monitoring than simple self-selection tests provide. Statins are prime example. ASHP’s Statement on Over-the-Counter Availability of Statins outlines the additional safeguards we believe would be necessary to ensure safe use of these medications without a prescription. They include, but are not limited to, recommendations from the patient’s clinicians, assessment and consultation with a pharmacist or other licensed healthcare professional, and the continued ability to prescribe these medications. If and when FDA considers OTC status for medications to treat chronic conditions, ASHP will provide detailed feedback on proposed conditions for safe use. Regardless, we urge FDA to consider an intermediate approach to OTC status, which would allow for the sale of products without a prescription, but only after consultation with a pharmacist or other licensed health care professional, for certain higher-risk medications such as statins.

  • OTC Status and Drug Access: Although pricing is not intrinsic to FDA’s drug approval process, we appreciate that FDA has recently expressed interest in pricing implications. Thus, we note that, in some instances, OTC approval can actually increase patient out-of-pocket costs for medications. OTC medications are not covered by insurance, and while OTC medications can be purchased using flexible spending account dollars, they are not eligible expenses for health savings accounts. Therefore, transitioning a product to OTC status does not always equate to increased consumer access to these medications.

ASHP appreciates this opportunity to offer FDA our feedback. Please contact me if you have any questions about ASHP’s comments on the draft guidance. I can be reached by telephone at 301-664-8696 or by email at [email protected].


Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs