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Browne Introduces Rx Right to Know Act
HARRISBURG -- Senator
Pat Browne (R-16) today announced that he has introduced Senate Bill 894, the
Prescription Drug Right to Know Act. This legislation would amend the
Controlled Substance Drug Device and Cosmetic Act to protect patients by
requiring the drug industry to provide full disclosure to doctors and the public
about the safety of the products they sell in Pennsylvania.
"Specifically, this
legislation would require that drug companies certify in writing to the
Secretary of Health that all of its clinical trials have been published in order
to sell or give away its products in Pennsylvania," Senator Browne said. "SB
894 also requires that drug companies register the start of all new clinical
trials with a federal agency and certify in writing to the Pennsylvania
Secretary of Health when that occurs."
Public confidence in the
motives of the big pharmaceutical companies has fallen as drug prices skyrocket
and manufacturers' profits increase. The public's mistrust was increased last
fall when Merck pulled Vioxx off the market amid reports that the
anti-inflammatory drug increased the risk of heart attacks and strokes.
"Drug manufacturers spend
millions of dollars each year in research and development efforts to create new
medications. Before any drug hits the pharmacist's shelves, it must undergo
numerous clinical tests and reviews by internal and external evaluators before
it can be approved by the FDA," said Senator Browne.
"However, as we are all
aware, pharmaceutical companies are not required to publish the results of all
clinical trials that test the safety or efficacy of their products," Senator
Browne continued. "As a result, many drug companies have published the results
of studies that are favorable to their products, while suppressing information
that show unfavorable results."
One of the key components of
the legislation is a proposal to create a state-administered website that would
provide links to all published clinical trials. Further, the taxpayers would
not have to cover the cost of maintaining this website. SB 894 would impose an
annual fee of $1,000 on drug manufacturers to offset the costs of maintaining
the website.
"That proposed $1,000 fee is
relatively insignificant compared to the earnings of the big drug companies,"
Senator Browne said. "Yet, the value of the information that would be then
available to consumers who want to make informed decisions about their
healthcare options would be priceless."
Remarks of Senator Pat Browne
Senate Bill 894/Rx Right to
Know Act
October 31, 2005
Our society has come a long
way since the days when families relied on the apothecary's shop for their
medicines. Back in that simpler time, the pharmacist would pull a bottle of
elixir from the shelf or mix up a special blend of herbs or chemicals to cure
the aches, pains and diseases of time.
Fortunately, the medical
sciences -- including pharmacology -- have advanced in ways that those old-time
apothecaries could never have imagined.
Undoubtedly, some of the
greatest achievements of the 20th Century were in the area of health care. In
1900, the average American could expect to live to be somewhere in the mid 50s.
In the year 2005, our life expectancy is now 77.6 years.
Much of that success in
increasing our longevity comes through the use of pharmaceutical products. The
well being of millions of people depends upon their regular use of drugs to
control diabetes, cardiovascular disease, cholesterol levels, depression or a
myriad of other physical and mental conditions.
Yes, we have moved beyond the
days when leeching to remove bad blood from an ill person's body was a widely
accepted form of medicine.
However, the familiar
surroundings of the corner apothecary have been displaced by chain drug stores
and pharmacies in discount stores and supermarkets. The days of the one-on-one
relationship at the drug counter are, for the most part, gone forever.
And, with the end of the
apothecary, we have also lost an element of trust.
The old apothecary certainly
didn't have the myriad of resources available today, but his customers trusted
that he would make the best possible decision in providing medicines for their
families.
As drug prices skyrocket and
manufacturers' profits increase, is it any wonder that consumers are questioning
the motives of the big pharmaceutical companies? The public's mistrust
certainly increased last fall when Merck pulled Vioxx off the market amid
reports that the anti-inflammatory drug increased the risk of heart attacks and
strokes.
Drug manufacturers spend
millions of dollars each year in research and development efforts to create new
medications. Before any drug hits the pharmacist's shelves, it must undergo
numerous clinical tests and reviews by internal and external evaluators before
it can be approved by the FDA.
However, as we are all aware,
pharmaceutical companies are not required to publish the results of all clinical
trials that test the safety or efficacy of their products. As a result, many
drug companies have published the results of studies that are favorable to their
products, while suppressing information that show unfavorable results, as the
case with Merck and VIOXX.
Congress and the FDA have not
addressed this issue and that is why the Pennsylvania General Assembly must act.
Today, I am announcing that I
have introduced Senate Bill 894, the Prescription Drug Right to Know Act. This
legislation would amend the Controlled Substance Drug Device and Cosmetic Act to
protect patients by requiring the drug industry to be honest with doctors and
the public about the safety of the products they sell in Pennsylvania.
Specifically, this
legislation would require that drug companies certify in writing to the
Secretary of Health that all of its clinical trials have been published in order
to sell or give away its products in Pennsylvania.
SB 894 also requires that
drug companies register the start of all new clinical trials with a federal
agency and certify in writing to the Pennsylvania Secretary of Health when that
occurs.
One of the key components of
my legislation is the proposal to create a state-administered website that would
provide links to all published clinical trials. Further, the taxpayers would
not have to cover the cost of maintaining this website. SB 894 would impose an
annual fee of $1,000 on drug manufacturers to offset the costs of maintaining
the website.
That proposed $1,000 fee is
relatively insignificant compared to the earnings of the big drug companies, Yet
the value of the information that would be then available to consumers who want
to make informed decisions about their healthcare options would be priceless.
None of us want to return to
the days of leeches, but it is time we restore confidence between the druggist
and the consumer. Requiring the publication of all clinical trial tests and
results will give doctors and patients the information they need to make the
right choices about prescription drugs.
 
Sen. Pat Browne introduces Senate Bill 894, the Prescription Drug
Right to Know Act, at an Oct. 31 news conference in the Capitol rotunda.
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