Future OTC Technologies Will Bring Regulatory Challenges – Gottlieb

Technological changes in the OTC drug marketplace will prompt changes in the approval process for nonprescription products, according to FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb, MD.

The current crop of investigational new drug applications reflects a shift in focus on the part of prescription drug firms: away from drugs for primary care indications and toward specialized conditions, Gottlieb said May 3 at the Consumer Healthcare Products Association's Scientific & Regulatory conference in Washington, D.C.

Driven in part by the reimbursement landscape and technological advances, the shift will lead to opportunities for development of new OTCs, particularly for chronic conditions, Gottlieb said.

"One of the things that is apparent to us at FDA is the nature of drug development itself is changing quite dramatically."

"If you look at the work burden on the new drug side at the FDA, we see far more meeting requests, far more intensity of work around new IND applications in the earlier stages of development. We think that this is a proxy for the increased complexity of the applications themselves - whether it's the indications the sponsors are seeking or the types of molecules they are developing," the deputy commissioner said.

"Certainly, the way the reimbursement environment is set up and is evolving with the bifurcation of how primary care drugs are reimbursed versus specialty care drugs, I think that's one big driver of companies taking a harder look at the specialized end of the marketplace."

"We have to contemplate how we change the delivery model," he said. "OTC pharmaceuticals, I think, in the future are going to be a big part of that."

New Technologies, New Approval Demands

The evolving OTC environment is "going to require changes to the approval process. It may very well require new approval models."

For example, the use of new technologies and venues to assist in consumers' appropriate self-selection of OTCs will create new regulatory challenges.

Gottlieb cited technologies such as "kiosks in the pharmacy, interactive websites, talking labels - things that allow patients to do point-of-care testing."

He pointed to the developing industry of in-store clinics such as MinuteClinics as a "very interesting innovation in the healthcare marketplace".

"But how we develop the framework that allows companies to capture the intellectual property of these kinds of innovations as part of the overall products that they are selling is a challenge," he said.

"It's a challenge on whether the FDA has a very clear pathway for doing that and whether or not it's going to require additional legislation," Gottlieb noted.

Office of Nonprescription Drugs Director Charles Ganley, MD, agreed that drugs paired with new technologies raise questions whether under agency regulations "something can be incorporated into an approval letter for conditions of use."

"I am a huge advocate for utilizing technology to improve the use and selection of OTC products," Ganley said. "I think in the next 15 or 20 years, if you expect to have a vision that some of these are going to be more chronic or preventive therapies, that's where you have to go."

"There are probably regulatory hurdles right now that have to be addressed to give companies the confidence to go forward and put research dollars in," Ganley acknowledged.

Electronic Labels

Labeling technologies under development for prescription drugs have implications for OTC drug distribution, the deputy commissioner said.

CDER launched structured product labeling (SPL) electronic labeling requirements for prescription drugs last November, and has targeted August for focusing on SPL for OTCs (¹ 'The Tan Sheet' Oct. 24, 2005, In Brief).

"One of the things we are doing as part of this redesigned label is create more opportunities to get information about drugs from the label available in electronic formats," Gottlieb explained.

This will "enable fully electronic archives of drug information in the future."

"One of the things we are working on - on a pilot basis with one such third party vendor - is kiosks that can go inside the pharmacies. You literally swipe the drug label over the kiosk, you use the barcode that's now required on all drug labels and you swipe it on the kiosk and you get a printout of different sections of the label that might pertain to your particular questions or needs."

This type of technology could be used to enhance use of OTCs by aiding in appropriate selection and identifying potential interactions, for example.

Gottlieb expects the nascent industry based on the collection, organization and delivery of this type of electronic drug information to grow rapidly.

"As more and more of this information becomes electronic, I think the growth in these kinds of third party vendors that grow up specifically to offer information at point of care is going to be significant."

Will Reimbursement Follow?

If OTCs do begin to fill therapeutic areas left behind by Rx drug makers, existing trends of payor interest in OTCs will likely accelerate.

The future OTC marketplace "may require new reimbursement models that compensate people for the products they purchase over-the-counter," Gottlieb said.

He praised the advent of health savings accounts and "the steps some insurers are taking to compensate patients, to reimburse for products purchased over the counter."

Gottlieb cited WellPoint and Aetna among companies who have led the way in promoting OTCs in therapeutic crossover areas. Both have worked to increase incentives to use OTCs such as Claritin and Prilosec OTC (² 'The Tan Sheet' Aug. 15, 2005, In Brief and ³ (Also see "Aetna Follows Claritin Model, Will Provide Prilosec OTC Coupons" - Pink Sheet, 13 Oct, 2003.), p. 11).

Emphasis On Prevention

The drug development process will be affected by the changing environment as well, Gottlieb said.

"There are many places where we could look at the development process and contemplate innovations to allow for the creation of more primary care medicines, more over-the-counter medicines."

Gottlieb cited preventive care as a particular area where the clinical trial process could evolve.

The industry and agency should look at "how we can create development processes and clinical trial models that make it easier and more efficient to develop claims and drugs aimed at primary prevention," he said.

The agency is planning a workshop "very soon" with the Drug Information Association, looking specifically at clinical trial models for pursuing prevention claims, Gottlieb noted.

The Company Model

The business model for companies marketing chronic condition OTCs will continue to move toward the model of consumer products firms and away from pharmaceutical companies, Gottlieb predicts.

"The kinds of companies that do this work in the future may well look more like consumer products companies, marketing directly to consumers."

Consumer products firms are equipped to develop "new kinds of strategies to get health information to consumers to empower them to take charge of their healthcare decision-making," he asserted.

"These are the kinds of things consumer products companies are very good at."

Is It Time For Behind-The-Counter?

As the environment for OTCs for chronic conditions develops, "we may well decide in the future that it's worth our while to engage in a discussion about behind-the-counter" sale as a third class of drugs, Gottlieb suggested.

The FDAer allowed there are "reservations in the industry about how exactly this would work in the United States." However, "engaging in that discussion again, I think, will be important in the near future.

The opinion that the U.S. should consider some form of intermediate third class of drugs has resurfaced at the FDA recently in the context of Rx-to-OTC switch.

Ganley has expressed his interest in exploring the topic, and advisory committee panelists during consideration of J&J/Merck's statin Mevacor showed an interest in revisiting a third class to handle the self-selection demands of a statin switch (⁴ (Also see "Mevacor OTC Panel Rejection Elicits Third Drug Class Talk" - Pink Sheet, 17 Jan, 2005.), p. 3).

- Christopher Walker