Bill Would Allow Two-Year Ban on Ads for New Drugs
Under a bill moving through the U.S. Congress this week, drug companies could be prohibited from advertising new prescription medicines directly to consumers for the first two years the products are on the market, the Associated Press reported.
The bill would give the Food and Drug Administration the power to impose such a ban.
Proponents say the new law would help guarantee that new medicines are safe before drug companies advertise them to consumers with the goal of getting patients to ask their doctors for prescriptions for the drugs.
"We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people," Consumer Reports analyst Bill Vaughn told the AP. "The real testing of these drugs takes place after a pill hits the market and that's why the advertising needs to be regulated."
The drug industry says the ads provide patients with important information about diseases and treatment options.
On Wednesday, the Senate committee that oversees the FDA will put the finishing touches to the bill, the AP reported.
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Most Poor People With HIV Don't Get Antiretroviral Drugs
Worldwide, only 28 percent of poor people with HIV have access to antiretroviral drugs that could save their lives, says a new report by the World Health Organization, Unicef and UNAids. HIV is the virus that causes AIDS.
The report also said there are still a number of obstacles standing in the way of the United Nations' target of universal access to HIV/AIDS prevention and treatment programs by 2010, BBC News reported.
By the end of 2006, just over two million people with HIV in low- and middle-income nations were receiving antiretroviral drugs. While that's 54 percent more than the previous year, the report noted that 7.1 million people with HIV still did not have access to the drugs.
The WHO had set a goal of providing antiretroviral drugs to three million poor people by the end of 2005, BBC News reported.
While the overall coverage rate for antiretroviral drugs was 28 percent, it was just six percent in the North Africa and Middle East regions. The report also said that just 11 percent of pregnant women with HIV are getting the drugs they need to reduce the risk that they'll pass the virus to their babies.
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Doctors Considering Removing Corzine's Breathing Tube
Doctors on Tuesday were trying to assess whether New Jersey Gov. Jon S. Corzine could breathe on his own and be taken off a ventilator. But they've said there's no timetable for when the breathing tube may be removed.
There are also plans to reduce Corzine's level of sedation and to give him some control over the amount of pain medication he receives, the Associated Press reported.
Corzine, 60, suffered multiple injuries last Thursday when the sport utility vehicle he was riding in crashed on the Garden State Parkway. As of Tuesday, he remained in critical but stable condition at Cooper University Hospital.
His injuries included: a broken left thigh bone; a dozen broken ribs; broken collarbone and chest bone; and a fractured vertebrae in his lower back. Doctors said he doesn't have any brain damage or paralysis, the AP reported.
So far, the governor has had three operations on his broken left leg. In the first surgery, doctors inserted a titanium rod. The other two operations were to clean wounds in the leg.
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Climate Change-Related Water Problems Will Affect U.S.
Climate change will cause major water-related problems for Americans, scientists and military experts conclude.
States will have disputes over control of rivers, lakes and other water sources, and floods and water shortages elsewhere in the world will result in increased conflict and terrorism that pose national security challenges for the U.S., the Associated Press reported.
U.S. scientists who helped write an international report on the effects of climate change said that the Great Lakes will shrink, coastal areas in the eastern U.S. will face increased flooding, and some areas of the U.S. Southwest will have to find new sources of drinking water.
On Monday, the scientists released their 67-page chapter on the effects of climate change in North America.
A separate report by a panel of retired U.S. military leaders also released Monday warned that water problems caused by climate change will increase conflict, terrorism and the need for international intervention in poor, unstable regions of the world, including Africa, the Middle East and South Asia, the AP reported.
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FDA Seeks 31 Percent Rise in Fees from Medical Device Makers
Under a U.S. Food and Drug Administration proposal, the medical device industry would have to pay 31 percent more in fees next year to help offset the costs of having their products reviewed by the FDA.
The agency wants to collect 31 percent more in 2008 and then 8.5 percent more each year through 2012 in order to collect $287 million in fees from the industry over those five years. That would cover only about 23 percent of the $1.2 billion the FDA estimates it will spend during that time to review medical devices, the Associated Press reported. The rest of the tab would be paid for by taxpayers.
The increased fees will help the FDA provide manufacturers with faster and more predictable review times for their devices, the agency says.
Some critics charge that the FDA's growing reliance on drug and medical device industry fees give companies undue influence over the agency's approval process, the AP reported.
The fee increase is included in the FDA's recommendations to Congress for reauthorizing the Medical Device User Fee and Modernization Act, which will expire Sept. 30 unless it's renewed by Congress. Public comments on the proposal are being accepted by the FDA for the next 30 days and a public meeting will be held April 30.
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