http://www.washingtontimes.com/news/2012/apr/29/fda-may-let-patients-buy-drugs-without-prescriptio/?page=all#pagebreak
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FDA may let patients buy drugs without prescriptions**** Move would
increase patients’ out-of-pocket costs****

By Paige Winfield
Cunningham<http://www.washingtontimes.com/staff/paige-winfield-cunningham/>
-****

The Washington Times****

Sunday, April 29, 2012 ****

In a move that could help the government trim its burgeoning health care
costs, the Food and Drug
Administration<http://www.washingtontimes.com/topics/food-and-drug-administration/>may
soon permit Americans to obtain some drugs used to treat conditions
such as high blood pressure and diabetes without obtaining a prescription.**
**

The FDA<http://www.washingtontimes.com/topics/food-and-drug-administration/>says
over-the-counter distribution would let patients get drugs for many
common conditions without the time and expense of visiting a doctor, but
medical providers call the change medically unsound and note that it also
may mean that insurance no longer will pay for the drugs.****

“The problem is medicine is just not that simple,” said Dr. Matthew
Mintz<http://www.washingtontimes.com/topics/matthew-mintz/>,
an internist at George Washington University Hospital. “You can’t just
follow rules and weigh all the pros and cons. It needs to be
individualized.”****

Under the changes that the agency is considering, patients could diagnose
their ailments by answering questions online or at a pharmacy kiosk in
order to buy current prescription-only drugs for conditions such as high
cholesterol, certain infections, migraine headaches, asthma or allergies.***
*

By removing the prescription requirement from popular drugs, the Obama
administration <http://www.washingtontimes.com/topics/barack-obama/> could
ease financial pressures on the overburdened
Medicare<http://www.washingtontimes.com/topics/medicare/>system by
paying for fewer doctor visits and possibly opening the door to
make seniors pay a larger share of the cost of their medications.****

The change could have mixed results for
non-Medicare<http://www.washingtontimes.com/topics/medicare/>patients.
Although they may not have to visit a doctor as often, they could
have to dish out more money for medications because most insurance
companies don’t cover over-the-counter drugs.****

“We would expect that out-of-pocket costs for insured individuals,
including those covered by
Medicare<http://www.washingtontimes.com/topics/medicare/>,
would be increased for drugs that are switched from prescription to OTC
status,” said Dr. Sandra Adamson
Fryhofer<http://www.washingtontimes.com/topics/sandra-adamson-fryhofer/>,
who testified last month on behalf of the American Medical
Association<http://www.washingtontimes.com/topics/american-medical-association/>in
an
FDA <http://www.washingtontimes.com/topics/food-and-drug-administration/>-held
public hearing.****

Pharmacists and doctors have lined up on opposite sides of the issue. Often
trying to combat a public perception that downplays their medical training,
pharmacists embrace the notion that they should be able to dole out
medication for patients’ chronic conditions without making them go through
a doctor.****

“We think it’s a great development for everybody — for pharmacists, for
patients and the whole health care system,” said Brian Gallagher, a
lobbyist for the American Pharmacists Association. “The way we look at it
is there are a lot of people out there with chronic conditions that are
undertreated and this would enable the pharmacists to redirect these
undertreated people back into the health care system.”****

Medical providers urged caution, saying the government should not try to
cut health care costs by cutting out doctors.****

“What the government via the
FDA<http://www.washingtontimes.com/topics/food-and-drug-administration/>has
decided to do is just bypass the expensive doctor and to satisfy some
safety concerns of letting people just pick out their medications is make
sure they have to get counsel by the pharmacists,” Dr.
Mintz<http://www.washingtontimes.com/topics/matthew-mintz/>said. “I
believe there is value to using pharmacists, but not at the
expense of primary care.”****

Although the 
FDA<http://www.washingtontimes.com/topics/food-and-drug-administration/>says
more patients will be likely to obtain the drugs they need under the
proposed model, Dr.
Fryhofer<http://www.washingtontimes.com/topics/sandra-adamson-fryhofer/>questioned
whether the agency has sufficiently proved that.
****

“The FDA<http://www.washingtontimes.com/topics/food-and-drug-administration/>has
not offered any evidence establishing that it is safe, or patient
outcomes are improved, when patients with hypertension, [high cholesterol],
asthma or migraine headaches self-diagnose and manage these (or other)
serious chronic medical conditions on their own,” she said.****

Comments on the proposal are due by May 7.****

FDA 
<http://www.washingtontimes.com/topics/food-and-drug-administration/>spokeswoman
Erica Jefferson said the agency will issue a decision sometime
after that but didn’t offer a more specific time frame.****

“The agency is still reviewing the public comments and will make a
determination on the best path forward once this has been completed,” she
said.****

** **

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