Plan B paves the way for new drug class

FDA invites public comment on behind-the-counter drugs; Plan B among the few such drugs in United States; already a popular classification in United Kingdom.

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By Aaron Smith, staff writer

NEW YORK ( -- Led by the emergency contraceptive Plan B, a new class of drugs called "behind-the-counter" is entering the FDA's spotlight.

As its name suggests, the behind-the-counter class, or BTC, resides in a pharmaceutical limbo between over-the-counter and prescription. Prescription drugs require a visit to the doctor's office, while over-the-counter drugs can be purchased right off the pharmacy shelves.

Behind-the-counter drugs require a green light from a pharmacist, but not a physician, before they are purchased.

So far in the United States, Plan B is the only prescription drug to switch to behind-the-counter status. On Wednesday, the Food and Drug Administration is holding a public meeting outside Washington, D.C. to hear opinions about opening up the BTC classification to more prescription drugs.

"The pharmaceutical industry, consumer groups, and some of the drug companies have been pushing the FDA to make certain prescription drugs available for dispensing behind-the-counter," said FDA spokeswoman Rita Chappelle, who declined to name any drug companies specifically.

The behind-the-counter class is already in use in Europe, Canada, Australia and New Zealand.

"The FDA is looking at creating a slightly more restricted class of over-the-counter drugs, similar to what we have in the U.K., what we call pharmacy-only drugs," said James McKean, analyst for the London-based research firm Atlantic Equities.

McKean said that GlaxoSmithKline's (Charts) acid reflux treatment Zantac is one of the "pharmacy-only" drugs available in the United Kingdom. He said the drug was off to a slow launch because some customers don't like answering pharmacists' questions about their gastrointestinal symptoms. But he added that, overall, switching a drug to BTC classification seems to boost consumer interest in them.

"It gives them a reputation of being more powerful, or being more medically relevant," said McKean.

Les Funtleyder, analyst for New York-based Miller Tabak, said that if behind-the-counter works in the United Kingdom, it will probably work in the United States.

"It's common in other places like Britain to have a behind-the-counter status and they haven't had many problems there as far as I can tell, so it's a viable distribution channel," said Funtleyder. "I think that as patients are becoming more responsible for their own medical costs, they're going to want more control of their healthcare, and behind-the-counter plays to that."

Barr Laboratories' (Charts) emergency contraceptive Plan B is the only drug in the United States that started out as a prescription before it went behind-the-counter in November of 2006. The drug is an emergency contraceptive with an 89 percent chance of preventing pregnancy if taken within three days after unprotected sex, according to Barr.

"[Behind-the-counter status] may make products a little more accessible, and in the case of Plan B, time is of the essence, but without a prescription most insurance plans won't cover the cost of the products," said Jake Hansen, vice president of government affairs for Barr Labs, in an email to

Nevertheless, the transition has actually helped sales rather than hurt them, said Hansen. Plan B's annual sales were $40 million when it was prescription-only, he said, but Barr projects those sales to double in 2007 under its new designation.

Ken Johnson, spokesman for the Pharmaceutical Research and Manufacturers of America, wouldn't say whether the drug industry supported or opposed the behind-the-counter designation.

Mevacor, a Merck & Co., Inc. (Charts, Fortune 500) cholesterol drug that lost patent protection in 2001, might be considered a behind-the-counter candidate in the United States, said McKean of Atlantic Equities. But Merck spokesman Ron Rogers said "the current system is adequate" and that a behind-the-counter designation for Mevacor "is not needed."

Instead, Merck is seeking over-the-counter status for Mevacor, and the FDA is holding an advisory committee meeting on this topic on Dec. 13.

Sometimes, the transition works the other way around, when over-the-counter drugs move behind the counter, though this is not the subject of the FDA meeting.

In 2005, retail giants Wal-Mart (Charts, Fortune 500), Target Corp. (Charts, Fortune 500) and Albertsons Inc. moved certain over-the-counter medicines, like Sudafed from Pfizer Inc. (Charts, Fortune 500) and Claritin-D from Schering-Plough (Charts, Fortune 500), behind the counter because they contained pseudoephedrine. This is a base compound in methamphetamine, a dangerous and illegal narcotic that has become the scourge of rural America. To top of page

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