Over-the-counter drug monograph reform the topic of subcommittee hearing

Under proposed legislation, “Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2017,” the over-the-counter (OTC) monograph process would be modernized to streamline rule-making and cut down on FDA resources, while being funded through the establishment of a user fee program. In a hearing before the House Committee on Energy and Commerce’s subcommittee on health on September 13, 2017 regarding the discussion draft, witnesses from the industry and the FDA voiced their support, as well as real world examples and reasoning, for the proposed changes.

Monographs and current process

Unless the FDA has approved a new drug application, the only way an OTC drug can be marketed is if it conforms to a monograph—a standard set of specifications established by the FDA for each therapeutic category of product—and is thus considered generally recognized as safe and effective (GRASE). A monograph is created through a three-step public rulemaking process via the Federal Register and a public comment period. It requires the convening of advisory review panels, publishing of an advanced notice of proposed rulemaking (ANPRM) with a comment period, review by the FDA, publishing a tentative final monograph (TFM), and later finalization of the monograph and subsequent amendments and updates. The FDA has around 88 rulemakings in 26 therapeutic categories covering over 100,000 OTC drug products, and there are 800 active ingredients for over 1,400 uses that the FDA oversees. There are no user fees associated with monograph products currently, and a small staff oversees the OTC program as well as attending to other current mandates. The rulemaking process spans many years and the industry waits for a decade or more for finalized monographs, for example, the ANPRM for external analgesic products was published in 1979 and the monograph has still not been finalized.


Since 2014, the FDA has examined monograph reform and the possible creation of a user fee program. The discussion draft includes proposes the following changes: (1) authorizing of the OTC Monograph User Fee Program; transition of OTC monographs from a rulemaking process to an administrative order procedures; (2) expediting administrative order procedures for OTC monograph drugs that pose an imminent hazard to public health or are associated with serious adverse events; (3) providing for a procedure to account for minor changes; (4) providing for a two-year exclusivity period for certain OTC innovative changes; and (5) clarifying how sunscreens would be reviewed.

Stakeholder witnesses

 Witnesses from across the industry presented statements before the subcommittee. They touched not only on the problems with the current process and their support of the proposals, but also their support in the industry supplementing the government’s efforts with the user fee program.

  • Bridgette L. Jones, MD, FAAP, representing the American Academy of Pediatrics (AAP), raised an example of how long it takes to get a monograph changed. Over a decade ago, in response to a petition to the FDA, an FDA advisory committee voted unanimously “that it was no longer appropriate for adult data on cough and cold products to be extrapolated to establish efficacy of the drugs in children under 12 . . . [and that] cough and cold drugs not be used in children under 6 years of age.” Currently, not even draft changes have been made to the monograph. She also noted that it is appropriate that the monograph be amended to provide dosing instructions for children under two years of age and that “if the monograph process worked better, surely this change would have happened years ago.”
  • Scott Melville, President and CEO of Consumer Healthcare Products Association (CHPA), notes the value that OTC medicines bring to the health of Americans and to the U.S. health care system and stresses that it’s important that the oversight process “is one that is efficient, transparent, and accommodating to innovation.” He also notes that his industry “is willing to supplement government resources with a modest user fee program.”
  • Kirsten Moore, Project Director, Health Care Products, The Pew Charitable Trusts, gave examples of the “unnecessary delay incorporated into a multi-step rulemaking system, which compromises FDA’s ability to respond swiftly to address new safety information and protect consumers” and urged Congress to pass the legislation as soon as possible.
  • Michael Werner, Partner, Holland & Knight, on behalf of the Public Access to SunScreens (PASS) Coalition, and Gil Roth, President, Pharma & Biopharma Outsourcing Association, also spoke in support of the OTC legislation.
  • Janet Woodcock, MD, Director for the Center for Drug Evaluation and Research (CDER) with the FDA confirmed the troubles with the current process and the present staffing levels raised by the other stakeholders. Her agency, as well as the other organizations, offered to continue to work with Congress to make the OTC reforms a reality.

FDA To Consider ‘Over-the-Counter-Plus’ for Certain Drug Approvals

The Food and Drug Administration (FDA) announced on February 28, 2012 it is seeking input on what it calls a “new paradigm” under which the agency would approve certain drugs that would otherwise require a prescription for over-the-counter (OTC) use under certain safe use conditions.

FDA said the safe use conditions would be specific to the drug product and might require the sale of the drug in predefined health care settings, such as a pharmacy. Additionally, some conditions of safe use could be designed to assist patients in self-selection of an appropriate drug or provide for follow-up monitoring during continued use. The conditions also could include requiring pharmacist intervention to ensure appropriate nonprescription use, the agency said in a notice published in the Federal Register.

FDA acknowledged that industry is developing technologies consumers can use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate. For example, kiosks or other technological aids in pharmacies or on the internet could lead consumers through an algorithm for a particular drug product. The algorithm could consist of questions that help consumers properly self-diagnose certain medical conditions or determine whether specific drug warnings contraindicate their use of a drug, FDA said.

The agency said it also is considering whether the same drug product could be available simultaneously as both a prescription and as a nonprescription product with conditions of safe use. “Dual availability could help ensure greater access to needed medications by making obtaining them more flexible,” FDA said.

FDA said the requirement to obtain a prescription for appropriate medication may contribute to the “undertreatment” of certain common medical conditions, including high cholesterol, hypertension, migraine headaches, and asthma. For instance, some consumers do not seek necessary medical care, which may include prescription drug therapy, because of the cost and time required to visit a health care practitioner for an initial diagnosis and an initial prescription, the agency said. Some patients who obtain an initial prescription do not continue on necessary medication because they would need to make additional visits to a health care practitioner for a prescription refill. Additionally, some prescription drugs require routine monitoring by a doctor.

FDA said some doctor visits could be eliminated by making certain prescription medications available without a prescription but with certain other conditions of safe use that would ensure they could be used safely and effectively without the initial involvement of a doctor. In some cases, a doctor visit would be required for the initial prescription, but a certain number of refills could be authorized beyond those that would normally be authorized without a return visit under specialized conditions of safe use like with certain rescue medicines such as inhalers, the agency said.
In addition to improved health outcomes for consumers staying on their medications, the time and attention that physicians and other health care providers expend on routine tasks related to prescription refills reduces the time that they are available to attend to more seriously ill patients, FDA said. Eliminating or reducing the number of routine visits could free up prescribers to spend time with more seriously ill patients, reduce the burdens on the already overburdened health care system, and reduce health care costs.
“The world is changing and we have to change to with it,” said FDA Commissioner Dr. Margaret Hamburg. “We’re not talking about abandoning standards for safety and efficacy, we’re talking about leveraging opportunities in science so we can do a more effective job as regulators and also improve the drug development process.”
The over-the-counter-plus switch is one of several FDA proposals aimed at increasing access to established drugs or speeding up approval of experimental medications. After years of high-profile drug-safety cases in which the FDA restricted access to certain medications, the agency is increasingly highlighting its efforts help drugmakers get new innovative drugs on the market. The shift comes as drug companies and their allies in Congress have pressured the agency to speed up approvals. Interest in creating a third category of drug products – something other than prescription or over-the-counter status is not new. In October 2007, FDA announced a November 14, 2007 public meeting to discuss the creation of a “behind the counter” (BTC) class of drugs – i.e., a class of drugs available behind the counter at a pharmacy without a prescription but that would require the intervention of a pharmacist before dispensing. This meeting was followed by a March 2009 report by the Government Accountability Office (GAO) which laid out, among other things, arguments supporting and opposing the creation of a BTC drug category.

The FDA will hold a public hearing on the over-the-counter-plus proposal on March 22 and March 23, 2012 from 9 AM to 4 PM at the FDA’s White Oak Campus in Silver Spring, MD. Additional information on the meeting is available on the FDA Web site.