Should the Process for Over-the-Counter Drug Approvals Be Modernized? (S. 2740)

What is S. 2740?

(Updated December 31, 2019)

This bill — the OTC Monograph Safety, Innovation, and Reform Act  — would change the monograph rulemaking process to an administrative order process (which is the same legal authority used for other medical product approvals. It would allow the Dept. of Health & Human Services (HHS) to take rapid action to protect public health if safety issues emerge.

The bill would also establish processes for manufacturers to request administrative orders, or for the secretary to initiate administrative orders at the recommendation of the FDA or in response to citizens’ petitions; and for drug developers to request meetings with the FDA, similar to existing processes for prescription drug development.

A new incentive would be created to bring innovative over-the-counter products to consumers by providing an 18-month period of product differentiation to reward innovation.

The Food & Drug Administration (FDA) would be required to provide an annual update to Congress on its evaluation of the cold & cough monograph with respect to children under the age of 6. The FDA would be authorized to collect user fees so that it has the necessary resources to evaluate & monitor the over-the-counter market.

Argument in favor

This bipartisan bill would modernize the FDA’s broken process for approving over-the-counter medical products to better serve the American public and allow for innovative products to reach the people who need them.

Argument opposed

This bill would make too many changes to the processes involved with bringing over-the-counter drugs to market, and doesn’t provide an adequate way to pay for the FDA’s oversight.

Impact

Over-the-counter drugs and those who consume them; pharmaceutical companies; and the FDA.

Cost of S. 2740

A CBO cost estimate is unavailable.

Additional Info

In-Depth: Sen. Johnny Isakson (R-GA) introduced this bill to streamline and modernize the FDA’s process for approving over-the-counter drugs:

“It is past time to modernize and overhaul our woefully outdated over-the-counter drug approval process. I’m reintroducing the Over-the-Counter Monograph Safety, Innovation, and Reform Act to help ensure that the health products in Americans’ medicine cabinets and on supermarket shelves are effective and accessible for patients, that innovations can be made well into the future, and that we promote competition to bring down costs for consumers.”

Lead Democratic cosponsor Sen. Bob Casey (D-PA) added:

“The over-the-counter monograph system is outdated and has not kept pace with the needs of the American public or the changing drug market for decades. The Over-the-Counter Monograph Safety, Innovation, and Reform Act would make commonsense updates to modernize the regulation of over-the-counter drugs to provide confidence to American consumers that non-prescription drugs have appropriate oversight from the FDA, and that the FDA has the authority to take swift action to protect public health should a safety problem occur. This legislation has been the product of years of work, and I urge the Senate to take swift action to pass it.”

This legislation has the support of four bipartisan cosponsors evenly divided between Republicans & Democrats, and passed the Senate HELP Committee without an amendment. In the last Congress, the committee approved this bill’s predecessor on a 22-1 vote.

Media:

• Sponsoring Sen. Johnny Isakson (R-GA) Press Release