This from the LA Times:
FDA drug proposal would bypass the doctor
The agency is floating the idea of letting patients get certain routine medications just by consulting with a pharmacist. Physicians, of course, are wary
By Daniel Costello, Los Angeles Times Staff Writer
October 5, 2007
Physicians may be losing their lock on Americans' medicine cabinets.
For years, consumers have had two options at the drugstore. They could either show up with a doctor's prescription or settle for less powerful medications sold over the counter.
Now the Food and Drug Administration is considering creating a different option, a class of medicines dubbed behind-the-counter drugs. It would let consumers purchase routine medicines that could include birth control pills, cholesterol drugs and migraine medicine without a prescription -- as long as they discuss it with a pharmacist first.
Pharmacists and drug companies like the idea; doctors think it's dangerous. If approved, the drug classification could go into effect as early as next year.
"We believe having certain drugs behind the counter but available only after a consultation with a pharmacist could significantly increase patient access," said Ilisa Bernstein, the FDA's director of pharmacy affairs.
But doctors are on alert. Dr. Anmol Mahal, a Fremont gastroenterologist and president of the California Medical Assn., said the federal agency's proposal was ill-conceived and unsafe for consumers.
"Patients are not clinicians," he said. "Allowing people to self-diagnose and self-treat is not in their best interest. Nothing could be farther from the truth."
Jaime Abramowitz disagrees. The 28-year-old human resources manager from Burbank said she would be comfortable getting at least routine medications without having to visit her doctor.
Abramowitz currently takes birth control and has to take as much as half a day off to get a checkup and refills every 12 months. "It's a pain going sometimes," she said.
Currently, only a few drugs are available behind the counter without a prescription. Best known is the morning-after birth control pill that was banned for over-the-counter sale in the U.S. until last year. Girls under 18 still need a prescription for the drug.
However, a much wider selection of behind-the-counter medications is available in Australia, Canada and several European countries. Several other countries are considering similar plans.
In the U.S., pharmacists, manufacturers and some consumer groups have made a concerted push in recent years -- with little success until now -- to create a federal regulatory category for medications that are known to have few safety issues and side effects.
Over-the-counter drugs typically sell for less than prescription medicines but often at much higher volumes and thus are potentially more profitable for manufacturers in certain cases.
Much will depend on which behind-the-counter drugs insurers decide to cover. Most insurance plans today cover prescription drugs but not over-the-counter drugs. Insurers say they are researching the FDA's proposal.
"Increasing patient control and access to medication while dramatically lowering cost to the consumer is a laudable goal," said Nicole Kasabian Evans, a spokeswoman for the California Assn. of Health Plans. "We would like to work with the FDA to learn more about their efforts."
The FDA announced plans Wednesday to examine the issue and spelled out details in the Federal Register. The move signals a possible change of heart in public policy and an indication that the government is trying novel ways of increasing the public's access to medications and reducing drug costs.
Just two years ago, an FDA panel turned down a bid by Merck & Co. and Johnson & Johnson to sell the cholesterol-lowering drug Mevacor without a prescription. At the time, several panel members said the agency should consider a behind-the-counter approval option. In January, Pfizer Inc. said it was considering seeking approval for its anti-impotence drug Viagra over the counter.
John Tilley, who owns four Zweber pharmacies in Downey and serves as president of the National Community Pharmacists Assn., sees the FDA's proposal as a "win-win" for patients.
Pharmacists are trained to consult about routine medical information, he said, and are often more accessible and spend far more time with customers than do their doctors. He added that greater access to medications might help patients without health insurance who otherwise might not be getting care.
"It's not like people would be getting these medications from a vending machine," he said. "This would include an adequate level of care."
Critics of looser oversight over the nation's drug supply, especially doctors, are less optimistic.
Mahal, of the California Medical Assn., said a main worry was that patients would buy medication and then lack supervision to ensure that their treatment was safe and effective. Another worry: that women who skip regular doctor visits to get prescriptions for birth control pills may also forgo gynecological examinations.
Bernstein, of the FDA, said the agency had several unresolved questions about how such a proposal would work in practice -- including how it could affect patient safety and whether it really would improve access to medications as much as some predict.
"We're still in research mode," she said.
The agency is planning to address those and other issues at a Nov. 14 public hearing about the plan and will seek written and electronic comments until Nov. 28.
There is no deadline by which the agency must make a final decision, although the process is likely to be concluded in the next several months.
On Thursday, the agency also said it would institute policies to shorten the backlog of more than 1,300 generic drugs awaiting approval by giving priority to decisions on products that are the first of their kind and giving applicants more feedback.
Generic drugs, which cost as much as 80% less than their brand-name counterparts, are now likely to get faster review, the agency said.
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