OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

Significant nonprescription drug innovations likely would start to reach the market within a few years of an overhaul of US FDA's OTC monograph program as manufacturers make proposals for formulation and other changes they've been sitting on due to the current system's problems, the Consumer Healthcare Products Association predicts

"We know a lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” said David Spangler, CHPA's senior vice president for policy, during the Food Drug Law Institute annual conference in Washington on May 4.

Monograph reform legislation has momentum this year as the House Energy and Commerce Committee on May 9 cleared its bill, H.R. 5333, for a floor vote. The Senate Health, Education, Labor and Pensions Committee did the same for a similar bill, S.2315, in April (see sidebar).

The current process requires rulemakings to add ingredients or delivery formats to an OTC monograph or add or change an indication. Both the House and Senate bills propose replacing the process with a system that allows FDA to use administrative orders to make changes and authorize a user fee program to pay for FDA’s work.

The bills, both based on a proposal FDA developed with industry input, would allow companies interested in adding or changing an indication or ingredient in a monograph to make an OTC monograph order request, or "OMOR." FDA would classify OMORs in two tiers – one would include most innovations such as new ingredients, indications, combinations test methods, routes of administration, doses or concentrations, and two would include a defined set of smaller, finite change, such as standardization of doses of a finalized ingredient within a particular finalized monograph or labeling changes. (Also see "Pediatric Provision Moves OTC Monograph Reform To Subcommittee Vote" - Pink Sheet, 16 Jan, 2018.)

In some cases when FDA decides small changes such as minor dosage form or labeling updating are needed, it could issue an administrative order on changes companies could make without incurring an OTC monograph user fee.

Spangler described the current system as dissuading commercialization with prohibitive barriers to developing products based on monograph changes.

For instance, currently a firm considering making a fast-dissolving strip to deliver an OTC monograph medication quicker and use less active ingredient faces a long and costly process for gaining FDA clearance for the innovation to be generally regarded as safe and effective. And once its added to a monograph, competitors are free to make and market products using the technology.

Those sorts of shelved technologies will begin to reach the market following a monograph program overhaul, he says. “We think those drawers are going to unlock. Not in the first couple of years, but year three, four and five, we think we will be seeing some of these innovations submitted to FDA and acted on.”

Spangler also said companies will benefit from an accelerated process to making product label changes. He noted an example of a company marketing sodium phosphate tablets and requesting adding a warning to the product due to FDA concerns about a rare but serious adverse effect. In order to make a change to its own labeling, the company had to ask FDA through a citizen petition.

“Here’s a company wanting to do the right thing,” Spangler said. As the firm just moved forward with its labeling change without approval, FDA could have found the company’s product misbranded. “FDA didn’t act against the, but that’s not the way to run a railroad.”

Spangler didn’t identify the company, but in 2008 the only manufacturer at that time of nonprescription sodium phosphate products available in the US, C.B. Fleet, voluntarily recalled its Fleet Phospho-soda products following an FDA safety alert on the kidney injury risks associated with using the products for bowel cleansing. (Also see "CB Fleet voluntarily recalls OTC OSP" - Pink Sheet, 22 Dec, 2008.)

Fleet, since acquired by Prestige Brands Holdings Inc., had removed the bowel cleanser indication two years earlier and in 2003 filed a citizen petition asking FDA to modify the OTC monograph for laxative drug products to include “professional labeling” for bowel cleansing and proposed dosing amounts. (Also see "FDA Amends OTC Oral Sodium Phosphate Labeling, Warns Of Risks" - Pink Sheet, 15 Dec, 2008.)

The monograph program overhaul would allow firms to use an expedited administrative process when FDA would an administrative order in interim final form if it expects a label change would mitigate "heightened' risks of adverse events, Spangler said.

“The point being, you know there is a safety issue. FDA, the industry and the public ought to be able to see that on a label sooner, not later,” he said.

From the editors of the Tan Sheet.