GAO Report Due on Behind-the-Counter Drugs

As FDA Commissioner Andrew von Eschenbach packs up his office, one thing he'll leave behind is a revival of discussions about a possible third class of drugs, sold behind pharmacy counters without a prescription. The concept is opposed by many drug makers, but championed by some who see it as a new path to broader access. When the National Association of Boards of Pharmacy discussed BTC drugs at its annual symposium in December, the Tan Sheet was there. Here's a Tan Sheet exclusive story on behind-the-counter proposals, and GAO's anticipated report, which is expected to shape FDA policy.

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FDA Awaits GAO Report To Guide Behind-The-Counter Policy 
 
The Government Accountability Office's anticipated updated report on a behind-the-counter class of drugs will help shape FDA's policy, according to Connie T. Jung, senior policy advisor for Pharmacy Affairs.

Jung spoke Dec. 5 at the National Association of Boards of Pharmacy's annual symposium in Tucson, Ariz., which included a discussion of a potential BTC class.

"We're in the exploring and discussion phase on this issue as we look at any information we have and as we wait for the results of the GAO report," she said. "I'm sure you'll hear something from us after that."

The report is an update of a similar investigation conducted by GAO in 1995. In January 2008, House Energy and Commerce Committee Chairman John Dingell and Oversight and Investigations Subcommittee Chairman Bart Stupak, both Democrats from Michigan, requested GAO revisit the topic.

In 1995, GAO examined 10 countries where BTC-like systems exist. The report concluded there was not enough evidence to support a third class in the U.S., with no hard evidence against it either.

Jung said the agency expects the new report "very soon," as GAO is in the "final steps" of preparation.

"We are waiting to see if this report will echo" the old report, or whether it will contain new information that supports a BTC class, she said.

According to the GAO's Public Affairs Office, the report is "expected to be delivered to the requesters at the end of January," but "is subject to a 30-day restriction" against public release.

The report's "scope and methodology" includes interviewing industry experts and FDA officials, reviewing previously gathered comments and materials and interviewing experts and officials in selected countries with established BTC classes.

Experts Say No Hard Evidence Yet

"I'm very interested to see if GAO comes up with the same finding again this time," said Frederick Branding, a partner at Reed Smith in Chicago and an ex-pharmacist,at the NABP conference.

Branding said later in an e-mail that it would be a "surprise" if GAO came to a different conclusion because he has not found new information that supports or argues against a BTC class.

Consultant Joe McGovern of Doylestown, Pa.-based firm The Atlantis Group says, "The short answer is there is still not much data that I know that really supports the development of a BTC class."

McGovern noted that some manufacturers support a BTC class to facilitate Rx-to-OTC switches, and "many" pharmacists back a third class. However, he noted, "Many European countries OTCs are still mostly BTC so we can't apply their experience easily" to a three-class system.

Asked if McNeil Europe's 2004 switch of Zocor Heart-Pro (simvastatin 10 mg) to "Pharmacy status" in the U.K. might provide evidence that could support a BTC class, Branding said "it may be too soon to tell how well that procedure" for statin availability in the U.K. is working.

Sidney Wolfe, director of the health research group at Public Citizen, noted the pending GAO report would help shape his view.

"I am not firmly against a BTC class nor for it," said Wolfe at the NABP conference, although he was positioned as an "opponent" during a point/counterpoint session.

"We need more research," Wolfe said, adding BTC systems are "grossly under-researched."

The Rand Report

McGovern cited a Rand Corporation working paper, "Potential Effects of Introducing Behind the Counter Drugs," which was published in August. Rand prepared the report for the office of the assistant secretary for planning and evaluation at the U.S. Department of Health and Human Services.

The authors attempted to use U.S. experiences with OTC drugs to forecast the impact of a third class.

Lead author Neeraj Sood and colleagues looked specifically at drugs switched OTC in the U.S. and how the switches impacted physician visits, utilization, patient health and medical costs.

The authors concluded the introduction of OTC or BTC drugs "generally cause patients to substitute toward" the nonprescription drug over prescription options "but the effect on overall use is more ambiguous, and depends to some degree on the structure of private and public health insurance."

The report determined there has not been much research on OTC/BTC status and its effect on patient health or medical costs. Some of the studies on the topic also "exhibit methodological issues," they said.

New Blood

Branding noted at the conference that the approaching change in administration will bring a new commissioner. New leadership could reframe the debate or strengthen or disperse interest in a third class.

"There will be new people, probably a new chief counsel ... So, this all will change. You never know right now. I'm going to assume that some of the people at the Food and Drug Administration don't either."

Outgoing Commissioner Andrew von Eschenbach reached out to the industry in 2007 to begin a discussion on the development of a third class .

The agency held a public meeting in November 2007 to gather comments from industry stakeholders and other experts on a potential third class.

The Canadian Experience

NABP also heard presentations from pharmacy experts from Canada, which has a BTC class.

Barbara Wells, founding executive director of Canada's National Association of Pharmacy Regulatory Authorities, who also was key in developing and implementing the country's harmonized drug schedule program, discussed the Canadian system.

"In a Canadian context, a behind-the-counter schedule is not without issues, but by and large seems to work well," she said.

Wells, a consultant and founder of B.A. Wells Healthcare Consulting, spoke during the point/counterpoint session as a "proponent."

Wells said the BTC class seems to offer a good way to manage certain products. Examples of drugs sold BTC in Canada include insulin and epinephrine-filled syringes, she noted.

She said consumers are sometimes confused by the distinction between OTC and BTC drugs, and public education is needed to explain why certain nonprescription medications require a pharmacist's consultation and are kept behind-the-counter while others do not and are available OTC.

Wells acknowledged there is a lack of evidence to support a BTC class, noting that countries with BTC classes, including Canada, seem to have done little research on the impact.

"This doesn't mean that there is no evidence. It doesn't mean that it's not effective," she said. "It just means there is not enough evidence to support either way at this point."

Wolfe noted that while the U.S. is looking at other countries' drug class models, those countries' health care systems and attitudes may be vastly different.

For example, he maintained health care is considered "a right," in Canada, while in the U.S. it is not.

- Katie Stevenson (k.stevenson@elsevier.com)