CHPA Switch Strategy: Behavioral Research, Medical Community Support

FDA has agreed to meet with the Consumer Healthcare Products Association to discuss the importance and relevance of conducting behavioral research to support Rx-to-OTC switch applications.

"Consumer/patient behavioral research" is a "new area of emphasis that we feel will assist in fostering an environment where switch is more predictable, less onerous and more frequent," President Michael Maves, MD, said during his 2001 report at CHPA's annual conference in Aventura, Fla. March 8-11.

The agency traditionally has been reluctant to consider behavioral research when reviewing switch NDAs, instead preferring clinical data, CHPA stated.

However, with most switches now focusing on drugs that treat chronic conditions, the use of behavioral research has become increasingly important to industry as a way of demonstrating that typical consumers can use such products correctly over extended periods of time, the association noted.

The desire to discuss behavioral research uses with FDA evolved from a meeting earlier this year between CHPA's Scientific Affairs Committee and association staffers, Maves said. At the meeting, it generally was agreed such research is crucial in supporting the concept of OTCs for chronic disease management rather than acute treatment.

Del Pharmaceuticals President and outgoing CHPA Chairman Charles Hinkaty echoed this position, noting new research tools are needed for "the future approval of complex switches for the management of long-term disease related conditions."

Recent attempts to switch medications for chronic conditions involved Merck's Mevacor and Bristol-Myers Squibb's Pravachol for hypercholesterolemia and AstraZeneca/Procter & Gamble's Prilosec for chronic heartburn. All three attempts were rebuffed by FDA advisory committees.

Several consultants have said studies comparing consumers' self-prescribing patterns and accuracy with that of physicians would strengthen industry's argument that drugs for chronic conditions should be allowed OTC. The American Pharmaceutical Association is overseeing studies on the benefits of pharmacist intervention in the treatment of osteoporosis and asthma (¹ (Also see "OTC Switches Would Be Facilitated Under Direct Refill Model" - Pink Sheet, 12 Feb, 2001.)).

To help gain support and possibly create momentum for increasing the number of OTC drug categories, CHPA also has begun to strengthen its ties with the academic medical community, Maves noted.

"I have met with a variety of physician and health care provider groups to expand the network of associations CHPA has traditionally been allies with," he said. "Interaction with these medical groups helps set the stage for collaboration and understanding of the role of consumers...in self-care and the broadening of indications" for OTCs.

Improving communication with the professional community may have been one of CHPA's objectives when it named Maves president in May 1999; a physician by training, Maves previously served as exec VP of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

Some of the groups Maves has met with so far include the American Medical Association, American Academy of Pediatrics, American Academy of Family Physicians and American Association of Medical Colleges. AMA recently came out in favor of OTC access to emergency contraceptives (² (Also see "AMA "Support" For Emergency Contraceptive Switch Applications Voiced" - Pink Sheet, 11 Dec, 2000.)).

Maves also noted he has been in touch with the Health Care Financing Administration and Agency for Healthcare Research & Quality.

Although expanded insurance coverage of OTC drugs and dietary supplements seems unlikely in the near future, Maves said incentives such as tax breaks for research conducted to support Rx-to-OTC switches potentially could arise out of the association's discussions with HCFA and AHRQ.

Maves additionally pointed to the association's efforts to increase its focus on international markets. CHPA has "identified Japan, Brazil and China as three major markets that we need to learn more about," he noted.

"When we speak of opportunities for increasing the rate of growth of OTCs and dietary supplements, here is where the future lies," Maves said.