Life Sciences Horizons Brochure 2025 - Flipbook - Page 119
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2025 Horizons Life Sciences and Health Care
FDA offers new way for nonprescription drugs to be marketed
This past year saw some noteworthy updates to FDA’s
regulation of nonprescription drugs, including a new
option for companies to bring nonprescription
drugs to market with an additional condition for
nonprescription use (ACNU), and FDA using the
administrative order process to propose two
significant changes to over-the-counter (OTC)
monograph drugs containing acetaminophen
and phenylephrine.
Last December, FDA issued a final rule allowing companies to
bring nonprescription drugs to market with an ACNU. An ACNU
is a condition that must be affirmatively fulfilled by a consumer
which ensures that a drug can be appropriately selected and used
safely and effectively without the supervision of a practitioner. An
example of an ACNU is a requirement for consumers to complete
a questionnaire to evaluate the consumer’s safety risk before
allowing the drug to be purchased.
FDA is requiring that the label of a nonprescription drug with
an ACNU contain instructions about the ACNU, such as directing
consumers to go to a particular website or retail location to
complete a questionnaire to check if the drug is safe for the
consumer. FDA said it hopes that allowing companies to market
nonprescription drug products with an ACNU will increase
consumer access to some drugs that are currently available only
by prescription, such as those that treat certain chronic diseases or
conditions. Some OTC drug manufactures have expressed
concern that this final rule will allow FDA to simultaneously
maintain prescription and OTC versions of the same drug
product, discouraging full switches for prescription drugs
to OTC drugs.
Over the past year, FDA also used the OTC monograph order
request process to propose significant changes to OTC monograph
drugs containing acetaminophen and phenylephrine. Last June,
FDA issued a proposed order to amend the OTC monograph for
internal analgesic, antipyretic, and antirheumatic drugs to add an
allergy alert warning that drugs marketed under the monograph
containing acetaminophen may cause severe skin reactions,
including skin reddening, blisters, and rash. And last November,
FDA issued a proposed order to amend the OTC monograph for
cold, cough, allergy, bronchodilator, and antiasthmatic drug
products to remove oral phenylephrine as a nasal decongestant.
FDA has solicited public comments on both proposed orders, but
has not yet finalized either.
Although the effective date of the ACNU final rule was originally
27 January 2025, it was delayed to 27 May 2025, due to a regulatory
freeze. This will provide time for the new Trump Administration
to consider whether to revise the ACNU rule, which would require
further notice-and-comment rulemaking.
Heidi Forster Gertner
Partner
Washington, D.C.
David Horowitz
Partner
Washington, D.C.
Bert Lao
Counsel
Los Angeles
