No-competition drugs stir controversy
WASHINGTON -- Barr Pharmaceuticals Inc. has finally begun to ship its morning-after pill labeled for over-the-counter sales, but not without raising new questions about how the federal government has handled the drug.
In exchange for conducting simple studies, including tests of how consumers use the emergency contraceptive and how they read and understand the new label, the Food and Drug Administration has granted Barr three years to sell Plan B without competition from makers of generic drugs -- so-called regulatory exclusivity.
Consumer advocates say the deal will unfairly prop up prices for Barr.
Plan B sparked a feud in which Democrats in Congress held up approval of a new FDA chief because they believed the agency was delaying its approval for over-the-counter sales of the medication for ideological reasons.
In August, the FDA granted permission to sell Plan B over the counter to women and men 18 and older. The company began shipping the medication, labeled for both prescription sales and over-the-counter sales, last week . Younger women and men still need a prescription to buy it in most states. Massachusetts state legislators, over Governor Romney's veto, endorsed a law permitting trained pharmacists to write that prescription, allowing them to dispense Plan B to all consumers, regardless of age.
Companies can request exclusivity after the FDA agrees that their prescription products can safely be sold over the counter. The FDA did not respond to questions seeking the number of exclusivity requests it has granted. While critics say such arrangements artificially inflate the prices of some medications, drug makers say exclusivity offers an incentive to conduct research that ultimately helps patients.
GlaxoSmithKline plc , which sells Nicorette , says exclusivity encourages manufacturers to bring innovative products to the market. When Nicorette in 1996 became the first smoking cessation treatment approved for over-the-counter sales, the FDA banned generic competitors until 1999. That's because the company had conducted two clinical studies examining how physicians prescribed it, and how patients who bought it with and without prescriptions used it.
The exclusivity provides "some incentive for innovation," said Melissa Dunn , a spokeswoman for Glaxo Consumer Healthcare. "It's really for companies who are doing all of the background research, investing the R&D dollars, and time and efforts into developing a product to give them some protection for a period of time."
But Public Citizen's Sidney M. Wolfe said exclusivity keeps generic competition at bay. So, for three years, consumers pay more than they should.
"They should get some advantage for it, but it seems like three years is on the long side," said Wolfe, director of the consumer advocacy organization's health research group.
Leaders of the new Democratic majority in Congress have said they will attempt to restrict some of the methods drug makers use to keep generic copies of their products off the market.
A Duke University researcher who conducts label-comprehension studies concedes they are not as time-consuming or expensive as traditional clinical trials that involve measuring drug concentrations in blood or monitoring such data as heart function to ensure drugs are not cardiotoxic. But Ruth S. Day , director of Duke's medical cognition laboratory, said the work is rigorous science, nonetheless.
The work is usually done one-on-one, sometimes selecting subjects from shopping malls. A researcher gives a consumer a drug package, the drug label, or both. The person reads it. The researcher tests the consumer on whether they understood what they read, sometimes with the label in hand. The tests plumb whether the consumer knows if the drug is a good choice, understands what side effects to expect, and knows how to tell when side effects are worrisome enough to seek medical attention.
Plan B has had a complicated regulatory history, marred by allegations that the FDA's decision-making was guided by Bush administration efforts to appease the Republican party's conservative base. Anti-abortion activists oppose easing sales of emergency contraception, which is intended to prevent pregnancy after a contraceptive fails or after unprotected sex.
Last week, a US magistrate ruled that the Center for Reproductive Rights could subpoena White House documents as part of a lawsuit it filed in 2001 against the FDA for failing to allow women of all ages to purchase Plan B without prescriptions.
Diedtra Henderson can be reached at dhenderson@globe.com. 
