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OTC Drug Safety, Innovation, and Reform Act
 
Q: How will the Over-the-counter (OTC) Drug Safety, Innovation, and Reform Act of 2018 change the regulation of OTC drugs?
 
 
imageThe pharmaceutical industry and regulators have long known that the regulation of OTC drugs needs serious reform. The FDA implemented the current monograph system for reviewing the safety and efficacy of OTC active ingredients in 1972. The system was reasonable at the time, but over the years it has evolved into a slow and cumbersome process that's unable to keep pace with current technology and science. This situation isn't acceptable for an industry that provides more than 60 percent of the medications sold in the US.
 
In testimony to Congress last year, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, outlined the challenges and drawbacks of the current system, which include:
  • Completing safety and effectiveness reviews of the OTC monographs is a burdensome and lengthy rule-making process, resulting in many OTC products still being marketed under incomplete monographs.
  • Addressing urgent safety issues swiftly and promptly occurs but doesn't result in the updating of relevant monographs. The FDA currently publishes notices to warn consumers and healthcare professionals of safety concerns and issues guidance documents encouraging the industry to make voluntary changes to their product formulations and/or labeling.
  • Keeping pace with evolving science or accommodating innovation with no established mechanism to do so is problematic, with eligibility being largely limited to active ingredients that were on the market before 1972.
  • Regulating all OTC monograph products effectively is impossible due to the FDA's lack of resources, which the agency has acknowledged.
 
Following Woodcock's testimony, Congress became involved and began a legislative process to address the issue. This legislation is making its way through both the House of Representatives and the Senate with bipartisan support. In July, the House, by voice vote, passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 (H.R. 5333). Likewise, on April 24, 2018, the Senate Health, Education, Labor, and Pensions committee approved the Senate bill, the Over-the-Counter Drug Safety, Innovation, and Reform Act of 2018 (S.2315), which Senators Johnny Isakson and Bob Casey co-sponsored. The Senate at large received the bill on July 18. While timing of its passage is unclear, the Senate has shown little objection to the actual substance of the bill.
 
Congress intends the proposed bill to replace the current slow and time-consuming regulatory procedures for monographs with an administrative-order process called an OTC Monograph Order Request (OMOR). Either a manufacturer who wishes to amend a monograph or the FDA, in response to a citizen's petition, can initiate an OMOR. These formal requests would be similar to, but not as extensive as, those for an NDA or ANDA product, and regulators anticipate that it will take no more than 2 years from the date of submission until the agency makes a final decision.
 
Clearly, as technology advances, both industry and consumers will benefit from this more efficient approach. For example, a pharmaceutical company could initiate an OMOR to request that the FDA add a new active ingredient or combination of active ingredients to a monograph, or perhaps a new indication or dosage form. Two innovation tiers exist within the bill:
 
Tier 1. Tier 1 includes changes to a monograph that require human data, such as when a request involves a new active ingredient or condition of use for which clinical data will be necessary to prove safety and efficacy. To encourage innovation for such a change, the legislation would authorize the FDA to grant up to 2 years of market exclusivity, thus delaying the entry of other versions of the same qualifying OTC product.
 
Tier 2. Tier 2 includes minor changes to the monograph, such as requests for new interchangeable terms, reordering of existing information in the Drug Facts panel, or modifications to the Directions or Other information section. These requests wouldn't grant market exclusivity.
 
To address safety concerns and other critical labeling changes that may be necessary, the bill provides the FDA with the authority to take rapid action when necessary, alleviating the need for issuing guidance documents in place of actual rulemaking. In addition, the bill specifically requires that the FDA re-evaluate the OTC cold and cough monograph with respect to children under the age of six and report annually to Congress on the progress of this evaluation. This requirement was prompted by a 2007 internal review that linked the deaths of 54 children younger than 6 years to overdosing with OTC decongestants and cough medications.
 
With regard to the monographs that the FDA hasn't yet finalized, the agency would consider all tentative final monographs (TFMs) to be final upon passage of the bill. The legislation would allow all Category 1 active ingredients—those already considered generally recognized as safe and effective (GRASE) in TFMs, with the proviso that the FDA could revisit this classification at a later date if new information becomes available. Likewise, the legislation considers Category 3 ingredients that have not received GRASE determination to be "legally marketed."
 
Obviously, these changes are quite significant and not possible without increased funding of the FDA. Therefore, the bill provides the agency with the authority to collect user fees to cover most of the costs associated with both updating the regulatory system and providing the necessary resources to evaluate and monitor the OTC drug market. These new revenues would come primarily from facility fees from registered establishments that manufacture OTC drugs. Contract manufacturers—facilities that make the drug products but don't market them under their own names or labels—will be charged two-thirds of the fee charged to facilities that both manufacture and market under their own names and labels. In addition to facility fees, additional revenue will come from both Tier 1 and Tier 2 OMOR submissions.
 
As noted earlier, the act is now awaiting Senate action. A great deal of bipartisan support for this bill exists as well as support from outside organizations, including the American Academy of Allergy, Asthma, & Immunology; the American Dental Association; and the American Academy of Pediatrics. The Consumer Healthcare Products Association (CHPA), the leading US trade association representing OTC drug manufacturers and marketers, also supports the bill. While the timing is uncertain, when the bill does pass, it will have an enormous impact on companies that manufacture and/or market OTC products in the US.
 

 
Susan Crane is independent advisor OTC for drugs and labeling, and Norma Skolnik is independent consultant at EAS Consulting Group, Alexandria, VA. EAS specializes in FDA regulatory matters, helping domestic and foreign pharmaceutical, dietary supplement, and biologics firms comply with applicable laws and regulations.
 
Do you have a question for our experts? Send your questions to pwright@cscpub.com, and we'll have an expert answer them.
December 31, 2018
 
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