Posts Tagged ‘FDA’

FDA Takes a Proactive Approach to Improving its Oversight

Wednesday, October 20th, 2010

FDA to spend $25 million to upgrade their review processes. The Food and Drug Administration (FDA) is upgrading the scientific tools they use to review prescription drugs, medical devices and to oversee food safety. According to FDA Commissioner Margaret Hamburg, her agency will spend $25 million next year to collect suggestions from scientists in academia, government and industry with the goal of approving new products faster and enhancing troubleshooting.  “Regulatory science can deliver better, more targeted therapies more quickly,” she said.

The FDA wants to pool resources on a variety of projects, including predicting the side effects of pharmaceuticals based on patients’ genetic codes; reduce or eliminate drug testing on animals; and prevent salmonella and other bacteria in the food supply.  Modernization is a constant theme at the FDA and the agency is working to keep up with the ever-evolving science behind the newest drugs, medical devices and even foods.  Unfortunately, federal funding at the FDA typically has not kept up with requests for budget increases.  This has resulted in user-fee programs where pharmaceutical manufacturers and medical device manufacturers pay to have their products reviewed.

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Preparing for the Next Pandemic

Thursday, September 2nd, 2010

Department of Health and Human Services plans to ramp up vaccine production to stem next flu pandemic. Now that the H1N1 swine flu pandemic has officially come to an end, the federal government is planning to change the way it works with companies to counteract new disease threats. Proposed actions include reforming the Food and Drug Administration (FDA) and creating centers that will make vaccines available more quickly than was possible previously. According to a Department of Health and Human Services (HHS) report, the nation’s ability to respond to pandemics is too slow and that changes must be made. The report also contains a plan to help researchers and biotech firms bring new drugs and vaccines to the market in record time.

“At a moment when the greatest danger we face may be a virus we have never seen before…we don’t have the flexibility to adapt,” said HHS Secretary Kathleen Sebelius. The report promotes clearer guidance to industry regarding the kinds of tests need to achieve regulatory approval of new drugs and vaccines, something the pharmaceutical industry has requested. The FDA plans to establish teams to expedite this process. Additionally, HHS and the Department of Defense plan to establish the Centers for Innovation in Advanced Development and Manufacturing, according to the report.

“These centers will provide assistance to industry and government by advancing state-of-the-art, disposable, modular manufacturing process technologies,” the report says. “Finally, in public health emergencies, these centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza.”

Dr. Harold Varmus, who wrote a separate report from the Presidential Council of Advisors on Science and Technology, said “Accelerated delivery of vaccines by even a few weeks can mean saving tens of thousands of lives. Sebelius noted that the government has not invested adequately in “regulatory science” – studying the optimal means to test new products. “Because of this under-investment, we are often testing and producing cutting-edge products using science that is decades old. We are also going to reach out to product developers earlier in the process so they know what to expect,” Sebelius said.

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Tanorexia An Addiction, Physicians Say

Thursday, June 17th, 2010

Like that tanning bed too much? It’s an addiction. A rite of spring when anticipating an upcoming prom finds many young women heading to the tanning parlor to get that certain glow to complement their special dress.  Little do they know that too much tanning can turn into an addiction and make them more prone to skin cancer.

Brittany Cicala of Chesapeake Beach, MD, learned about the dangers of tanning the hard way.  At age 17, she headed to the tanning salon so she would look “tan and healthy” in the white lace dress she had chosen to wear to her prom.  Even after the event, Cicala – a blue-eyed blonde with fair skin – kept on tanning, often spending 20 to 25 minutes in the bed seven days a week.  In the summer of 2004, Cicala found a mole about the size of a nickel on her back.  When the mole started to bleed, she went to the doctor, was diagnosed with melanoma, and in the six years since has undergone 34 surgeries.  Cicala today describes herself as “tanorexic”.

According to Dr. Robin Hornung, a pediatric dermatologist in Washington state, melanoma rates are growing fastest among young women, and notes that many experts are suspicious of tanning beds.  A study by the University of Minnesota determined that melanoma risk increased as much as three times among people who tanned more than 50 hours, or had spent more than 100 sessions in a tanning bed.  The World Health Organization has classified tanning beds as carcinogenic and recommends banning young people under 18 from using them.

Tanorexia points out the importance of getting outpatient screenings in community-based settings to preemptively prevent melanomas and other cancers.

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Michelle Obama Asks Grocery Manufacturers for Healthier Foods

Wednesday, May 12th, 2010

First Lady takes the offensive for childhood obesity.First Lady Michelle Obama recently took her initiative against childhood obesity to the source, asking companies at a meeting of the Grocery Manufacturers Association to “step it up” and add less fat, salt and sugar to foods.  “We need you not to just tweak around the edges but entirely rethink the products you are offering, the information that you provide about those products, and how you market those products to our children,” she said.

Although Mrs. Obama has addressed schools and nutrition groups about childhood obesity, this was the first time that she faced the companies that make the snacks and junk food that contribute to the problem.  The Grocery Manufacturers Association – whose members include Kraft Foods, Inc., Coca Cola Co. and General Mills, Inc. – had invited the first lady to speak at its science forum and gave her a standing ovation.

Mrs. Obama called for food labels that are less confusing, smaller portion sizes and increased marketing of healthy foods.  She also urged the food companies to find creative ways to market products as healthy, increase nutrients, and reduce the number of bad ingredients.  “While decreasing fat is certainly a good thing, replacing it with sugar and salt isn’t,” she said.  “This needs to be a serious industry-wide commitment to providing the healthier foods parents are looking for at prices they can afford.”

Scott Faber, a grocery association lobbyist, said his industry is working with the government to find ways to produce healthier foods.  “Consumers are demanding more and more healthy choices.  Our industry will do our part by changing the way we make and market our foods, but government has a big role to play as well.”

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Hotdogs Called Hazardous to Children’s Health

Thursday, March 11th, 2010

Pediatricians say hotdogs are a choking hazard for childrenThe hotdog has become a center of controversy – not because of its fat, sodium or preservatives content – but because the American Academy of Pediatricians thinks the sausage should come with a label that warns of choking hazards for babies and children.

If that’s not possible, the academy would like to see hotdogs redesigned so their shape, size and texture make them less likely to get stuck in a child’s throat.  More than 10,000 children 14 and younger are treated in ERs every year after choking on food; as many as 77 die.  Approximately 17 percent of food-related asphyxiations are hotdog related.

“If you were to take the best engineers in the world and design the perfect plug for a child’s airway, it would be a hotdog,” said Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, OH.  “I’m a pediatric emergency doctor, and to try to get them out once they’re wedged in, it’s almost impossible.”  Smith notes that the Consumer Product Safety Commission requires labels on toys with small parts, but takes no position on foods, even though more than 50 percent of non-fatal choking incidents involve food.

The National Hot Dog & Sausage Council supports the academy’s plan to better educate parents about choking prevention.  According to council president Janet Riley, “As a mother who has fed toddlers cylindrical foods like grapes, bananas, hotdogs and carrots, I ‘redesigned’ them in my kitchen by cutting them with a paring knife until my children were old enough to manage on their own.”

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