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Adding bite to FDA screening

...For example, when new drugs are widely advertised to consumers before the risks are known, thousands of those who take them may be harmed.

Most could have been treated by older, safer, cheaper drugs.

That's why the American Medical Association, most physicians, and the Institute of Medicine - a respected nonprofit that offers advice on biomedical issues - recommend a two-year moratorium on direct-to-consumer advertising of all new drugs.That sounds like a great idea, but the Senate bill rejects it.

Instead, it would allow (but not require) the FDA commissioner to impose a moratorium only when there is clear evidence that advertising to consumers would harm patients.

This is hard to prove because new drugs lack data on widespread use.

Even worse, Kennedy's bill doesn't even require the FDA to review new drug ads for accuracy.The Institute of Medicine also calls for reducing conflicts of interest among FDA advisory panel members.

A few weeks ago, the FDA adopted some of those suggestions.

It proposed to exclude from advisory panels all doctors and scientists with financial ties of more than $50,000 in the previous 12 months to the products under review; those with a lesser financial interest could still serve on the committees, but only as nonvoting members.Having any advisers with a financial interest is like having referees who bet on their own games - an obvious conflict of inte...

FDA Lifts All Restrictions on Boston Scientific's Minnesota ...

...The FDA then sent Guidant a warning letter about deficiencies at the plant in December 2005, all of which have now been resolved.

Boston Scientific is now free to seek approvals for new devices in the $10 billion-a-year global market for pacemakers and implantable cardioverter "[T]he competitive dynamics have changed over the past year and it remains to be seen how successful and quickly (Boston Scientific) will be able to take back lost ICD market share," said Bank of America analyst Glenn Novarro.

Boston Scientific has yet to resolve a second warning letter about quality control problems at plants in Massachusetts, Minnesota and Indiana.

Sources: MarketWatch, Reuters, CNN.com, Bloomberg, 24/7 Wall Street Commentary: Bypassing Surgery - Will Stents Survive The Bad News?

• Boston Scientific Addresses Quality Issues at JPMorgan's HealthCare Conference • JNJ, Boston Scientific Heart Stents Are Safe, Says FDA Stocks/ETFs to watch: Boston Scientific Corp.

(BSX).

Competitors: Johnson & Johnson (JNJ), Medtronic Inc.

(MDT), St.

Jude Medical Inc.

(STJ), Abbott Laboratories (ABT).

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Session focuses on weapons in schools

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