WASHINGTON, June 28 - Public hearings are set to start Wednesday, as the
Food and Drug Administration considers whether to switch a number of
prescription-only drugs to over-the-counter sale, The New York Times reported.
Evidence given during Wednesday and Thursday's hearings could see a number
of medicines -- possibly including antibiotics and birth control pills -- go
on sale without a doctor's prescription, the newspaper said in an article
Wednesday.
The FDA next month is also due to convene a panel of scientific experts to
evaluate applications from two drug manufacturers, Merck and Bristol-Myers
Squibb, for low-dose versions of their anti-cholesterol pills to be sold over
the counter.
This week's hearings will see the FDA make its first re-examination since
1972 of how it regulates over-the-counter drugs, The New York Times said.
The last review saw the FDA create a new system for approving
over-the-counter drugs, in which more than 600 drugs were transferred from
prescription to non-prescription status.
This time round, the FDA will examine whether patients with conditions more
serious than mild headache or athlete's foot should be able to treat
themselves.
The agency will now question whether more chronic conditions like high
blood pressure, high cholesterol, and osteoporosis, should be treated by the
patient.
"The health care environment has changed tremendously in recent years,"
Robert DeLap, the agency official heading the review was reported as saying.
"People are much more interested in self-care, and in being able to manage
their minor conditions themselves."
The decision could have a major impact on the 100 billion-dollar
pharmaceutical industry. It coincides with a political debate in Congress
analysing who should pay for medicines and how much they should cost.
Some 55 people will testify at this week's hearings including drug and
insurance company officials, safety advocates and infectious disease
specialists.
The latter are concerned about antibiotic resistance.
Meanwhile, opponents to abortion are currently fighting over-the-counter
sale of a birth control pill, which, taken in high doses can be used as a
morning-after contraceptive, the newspaper added.
