Friday, November 27, 2009

HealthDay

Health Highlights: July 11, 2008

Posted July 11, 2008

"It is true that what the AMA did historically was awful," Dr. Otis Brawley, chief medical officer of the American Cancer Society, told the AP. "There were AMA local chapters that actually had rules against black members well into the late 1960s, and policies that made blacks not feel comfortable well into the 1980s."

The apology is part of an effort by the group, long thought of as the voice of American doctors, to pare or eliminate racial disparities in medicine, the AP said.

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FDA Making Drug 'Non-Approval' Letters Easier to Swallow

The U.S. Food and Drug Administration says it wants to make it easier for drug companies and their investors when the agency decides a new drug isn't quite ready for approval.

In changes to take effect Aug. 11, the existing "not-approvable" letter will be replaced by a "complete response letter" when a drug isn't ready for sale in the United States, the agency said on its Web site.

"In the past, some drug manufacturers expressed concern that a not-approvable letter sent an unintended message that a marketing application would never be approved, which could adversely affect a company's ability to raise capital," according to a 122-page overview of the new policy cited by the Bloomberg news service.

The redesigned letter, the agency said, will elaborate on what's missing from the original application, and how the company may be able to correct it.

Currently, when drug makers apply for a brand-name drug's approval, they pay application fees in exchange for a promise from the FDA that it will act within 180 days. The new rules include provisions for how long the process will be extended when the companies are asked for additional information, Bloomberg said.

The new response letter may not be as accessible to investors as the current FDA protocol dictates, prompting some critics to wonder whether shareholders will be in the dark about the status of drugs' "approvability," the news service said.

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Controlled Drugs Easily Obtained Online Without Prescription

Powerful addictive drugs -- known as controlled substances because of their potential for abuse -- are easily ordered online, and in most cases without a prescription, a new Columbia University study finds.

Of 365 Web sites that sold controlled substances regulated by the U.S. Drug Enforcement Agency (DEA), 85 percent of the sites did not require a prescription, according to an Associated Press analysis of the study.

Examples of drugs that could be purchased this way included the potent painkillers morphine and oxycodone, and amphetamine stimulants.

The study found that the number of sites that sold controlled substances actually fell 37 percent from last year's analysis. The researchers cited efforts by law enforcement to crack down on illegal online drug sales.

About 80 percent of online prescriptions are for controlled substances, according to DEA statistics cited by the wire service. By contrast, these same drugs account for just 11 percent of sales at traditional pharmacies, the DEA said.

The House of Representatives is considering a bill to ban the sale of controlled substances online without a prescription. The Senate has already passed the measure.

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