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Let FDA, not courts, write drug labels

Let FDA, not courts, label drugs

Contrary to the conclusion of your editorial (Court should stand with injured patients, Nov. 12), there is a sure-fire way to bolster drug safety and better serve patients: a strong, well-funded Food and Drug Administration.

Lawsuits challenging the adequacy of medicine labeling are no substitute for the FDA's expert scientific judgment.

Importantly, in the case before the Supreme Court, the FDA's actions led to appropriate warnings on the drug's label.

For the past 70 years, Congress has granted the FDA sole authority over warnings that appear on drug labeling. It's a muscular authority that the FDA takes seriously and, in recent years, the agency has given especially careful thought over the prominence and clarity of warnings.

What's more, the FDA has new authority — and has effectively used it — to compel companies to update labeling as new information becomes available.

To b e sure, juries and judges could attempt to accomplish the FDA's careful balancing of benefits and risks, swayed by the powerfully emotional appeal of the plaintiff seated before them.

The inadequacy of this approach was underscored by five former FDA chief counsels, who maintained in a bipartisan letter: "If every state judge and jury could fashion their own labeling requirements for drugs and medical devices, there would be regulatory chaos for these two industries that are so vital to public health, and FDA's ability to advance the public health by allocating scarce space in product labeling to the most important information would be seriously eroded."

Public health benefits from a single drug safety arbiter striving for national uniformity and rational decisionmaking.

Diane Bieri, executive vice president and general counsel, Pharmaceutical Research and Manufacturers of America, Washington

Citizens customers have a right to choose Nov. 15, letter

Underhanded maneuver

If Citizens is serious about preserving its policyholders' right to choose their insurance provider, then it has the opt in/out process 100 percent backwards.

Citizens is not adequately protecting consumers' right to choose when it endorses other insurers sending what looks like junk mail to us that requires us to opt out versus opt in. Our signature to opt out of Citizens is just common sense.

It's bad enough that Florida residents are held captive to skyrocketing homeowners insurance, property taxes and utility bills. Please don't rub salt in the wound with this underhanded maneuver.

Kathy Donohue, St. Petersburg

Policy hijacking is wrong

I am appalled that an insurance company can insure my home, with the blessing of Citizens, by merely "sending" me a letter giving me the option to "opt" out of their coverage. Isn't this backwards? Shouldn't I have to ask them to take my coverage over, not make sure that I document that I don't?

So all an insurance company has to do is: Not send the letter to me and say they did, send the letter to the wrong address, ignore my response to opt out, or just refuse or ignore my certified letter opting out. Don't think that could happen? Think again, according to a Nov. 15 letter to the Times.

Government is here to serve the people, not the private companies. For Citizens to support such a system of policy hijacking is preposterous.

Marty Chambers, Largo

Haley: Sorry for vet's death | Nov. 15, story

Wonderful care at Haley

I am very sorry for the family of Mr. Szamlewski, however my recent experience with the James A. Haley VA Medical Center was just the opposite.

Seven years ago my husband and I became the guardians of my brother, 20 years my senior. He became ill and so began our visits to the VA.

I had been a pharmaceutical sales rep for 15 years, so I had experience dealing with physicians and hospitals. I dreaded going to Haley due in part to its sheer size, however I was surprised at what I found.

Our appointments with onclogy were always timely, the staff was always courteous and my brother had a wonderful oncologist. My brother's cancer had spread; the physicians still continued to treat him until he said he had enough. That day his hospice care began.

I understand the frustration that comes from receiving care from a huge hospital. My best advice to patients is to be your own health care advocate, or allow a loved one to do it for you. If you are to be discharged and your life depends on oxygen, demand the oxygen before the discharge. I know it is a lot to remember in times of stress, but as this sad story demonstrates it can mean the difference between life and death.

James Haley is overcrowded and the inside is depressing and bleak, however as a health professional I have nothing but praise for the people who work there.

Cheryl McCormick, Brooksville

Convention center idea back | Nov. 11, story

Wrong project, wrong time

At a time of major economic strife, tax collection losses and a 30 percent drop in some hotel occupancies as reported in your paper last week, why on earth would our politicians consider building a Pinellas convention center?

Some of the first cuts companies make are meetings and unnecessary travel. Event bookings at many facilities are being cancelled or downsized. Rather than be thinking about how to spend money that is getting tighter by the day, how about a new way of thinking to save money?

This economic downturn could last for years.

Jeff Francis, St. Petersburg

You sent my mom to where? | Nov. 19, story

Lost in transit

I read with interest your story of the woman sent by U.S. Airways to Puerto Rico instead of Tampa. When I flew with U.S. Airways to New York state with my mother's ashes for a family interment ceremony, they lost the bag with my mother's remains.

A day of phone calls finally resulted in the bag's return from the Philadelphia hub it had not been forwarded from. On my return trip, a woman seated behind me learned that she was on a Tampa flight, although she had a Las Vegas boarding pass.

And yes, when I reached Tampa I learned that U.S. Airways had again lost my bag.

Vince Dempsey, St. Pete Beach

Benefits of raising gas tax

A 50-cent or $1-a-gallon new tax on gasoline would be an unpopular step, but it would produce a win-win result.

When gas prices stay up, investment in alternative energy goes up, the desire for gas-guzzlers goes down and the development of fuel-efficient cars and hybrids is speeded up.

People in low-income brackets who are hurt by increased gas prices can be compensated through tax rebates.

The federal income from an additional tax on gas should be used for the good of all people, including health care, infrastructure, schools and research and development of renewable energy.

Per A. Hakansson, St. Pete Beach

Let FDA, not courts, write drug labels 11/20/08 [Last modified: Friday, November 21, 2008 11:06pm]
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