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FOR IMMEDIATE RELEASE
October 31, 2005

Sen. Browne introduces Rx Right to Know Act
Senate Bill 894 would open clinical test results

Senator Pat Browne 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."

Contact:

Matt Moyer
(610) 821-8468

 

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Remarks of
Senator Pat Browne
Senate Bill 894/Rx Right to Know Act

October 31, 2005

Thank you for coming out this morning.

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. 

Thank you.