On the evening of July 16, the House passed a sweeping over-the-counter (OTC) drug regulation reform bill, bringing the first changes to the system in over four decades. The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 would amend the Food and Drug Administration’s (FDA) OTC drug review process by expanding the $8 million budget, adding roughly 100 employees to oversee it, and setting in place a five year, $134 million user fee system known as OMUFA. Additionally, on July 17, the FDA issued a draft guidance on over-the-counter drugs.
OTC Drug Bill
The measure, H.R. 5333 (115) (summary) would grant just 18 months of exclusivity to manufacturers of innovative OTC drugs. It also includes a provision that requires the Government Accountability Office to conduct a study no later than four years after the bill is enacted to assess the “overall impact of exclusivity … including its impact on consumer access.”
Prospects remain uncertain in the Senate, where a similar bill by Johnny Isakson and Bob Casey, S. 2315 (115), was approved by the HELP Committee earlier this year. While there have reportedly been objections raised by some Members who are working through unrelated issues with FDA, those members do not have objections to the substance of the bill. Once the issues are resolved, the bill is not expected to need floor time to pass in the upper chamber. While differences between the House and Senate legislation are minor, it remains unclear how they might ultimately be reconciled.
Draft Guidance
In the draft guidance, FDA details two new approaches to making nonprescription drugs available in situations where information in the drug facts labeling (DFL) is not sufficient to support OTC use. The guidance aims to provide an easier pathway to demonstrate safety and effectiveness without relying solely on DFL by: (1) developing labeling in addition to the DFL, and (2) implementing additional conditions that will allow consumers to self-select and use the product safely. The proposal also would encourage the use of other tools that can serve to educate patients on potential treatment options, such as a digital platform that would provide more easy-to-access information than traditional DFL. The new procedures would apply only to the New Drug Application (NDA) process under the FDA’s purview, and is specifically intended to extend the NDA pathway to include therapeutic indications that have not historically been available for use without a prescription.
In a statement from FDA Commissioner Scott Gottlieb, he notes the impact on patients:
“Our hope is that the steps we’re taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription. Clearly, not all prescription drugs can or should be available directly to consumers. Many require a professional diagnosis and oversight to ensure the benefits of use outweigh the risks. But other, select types of drugs, are appropriate for nonprescription use if we are able to ensure access to resources that will help patients determine if the medicine is right for them. These are the products that we will carefully consider for this innovative pathway.”