Re: A Bombshell Drops on Cholesterol Medication's Glass House

Now - write congress referencing this and the Ban on Direct to Consumer advertising!! Use this to contact congress. Article on the ban follows (if I get this HTML correct......:)

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************************************************************************************************************ http://www.nj.com/news/ledger/index.ssf?/base/news-10/1163745172307060.xml&coll=1 exec says pharma will fight ad ban First Amendment and self-policing cited at Senate panel hearing Friday, November 17, 2006 BY ROBERT COHEN STAR-LEDGER WASHINGTON BUREAU WASHINGTON -- The pharmaceutical industry sent a warning yesterday that it will oppose restrictions on direct-to-consumer advertising when Congress takes up legislation next year to strengthen federal drug safety regulations.

Adrian Thomas, a Johnson & Johnson vice president, told a Senate committee a bill calling for up to a two-year moratorium on direct-to-consumer advertising for newly approved drugs "represents a troubling change."

"Many members of the industry, including Johnson & Johnson, have voluntarily agreed to exercise restraint with respect to DTC advertising, especially during the period of time after approval," Thomas said in testimony before the Senate Health, Education, Labor and Pensions Committee.

"Appropriate DTC advertising plays a valuable role in educating patients about diseases and treatments," he said. "The value of this education to patients, as well as important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area."

A counter view was offered by Consumers Union President Jim Guest, who said the drug safety bill sponsored by Sens. Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.) should allow the Food and Drug Administration to limit advertising on new drugs for three years, not just two as proposed.

Guest said consumer advertising by drugmakers -- accounting for $4 billion a year in spending -- is not an educational tool, but a vehicle to mass-market drugs before all possible serious side effects are known.

"The direct-to-consumer advertising is not a good way for consumers, physicians or medical providers to be informed," he said.

The advertising issue is just one facet of a much broader debate on overhauling the way the FDA regulates the drug industry.

The FDA has come under heavy fire in the past few years because of a string of high-profile drug recalls and safety warnings, including the 2004 withdrawal of the popular painkiller Vioxx after long-term use was linked to an increased risk of heart attacks.

Kennedy, who will take over as chairman of the health committee when Democrats assume control of the Senate in January, said drug safety legislation will be a top priority.

"Millions of Americans rely on the drugs that the FDA reviews to protect them from sickness. But now, the FDA itself urgently needs treatment," he said.

Sheila Burke, chairwoman of an Institute of Medicine panel that in September produced a damning report on the FDA's drug safety oversight, agreed. "If there ever was a time that it was critical to address these issues, it is now," she said.

The IOM found the FDA cannot effectively track the safety of new drugs or respond quickly to problems because of a lack of money and staff and weak enforcement powers.

The Kennedy-Enzi bill would require pharmaceutical companies to devise safety plans for new drugs, mandate more disclosure of clinical trials, give the FDA authority to order labeling changes and require companies to carry out safety studies of drugs once they are on the market.

It would also give the FDA power to require pre-clearance of consumer advertising, mandate specific disclosures and prohibit ads for up to two years after a drug has been approved if disclosures alone are not adequate to protect public health.

The FDA currently monitors print and broadcast advertising for fairness and balance. It also encourages, but cannot require, drugmakers to submit ads for review in advance of airing or publication.

Facing heavy criticism over industry marketing tactics, the Pharmaceutical Research and Manufacturers of America in 2005 issued voluntary guidelines calling for companies to submit advance copies of ads to the FDA and to clearly state the health conditions for which the medicine is approved, as well as its major risks.

Twenty-three drug companies agreed to the guidelines. In addition, Bristol-Myers Squibb said it would not advertise new drugs to consumers for one year after approval, while Pfizer said it would impose its own six-month moratorium.

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