FDA Regulations

A new electronic early detection system utilized by the Food and Drug Administration logged 125 primary reports of unsafe food or animal feed in the first seven months of operation, keeping the potentially dangerous food out of the mouths of consumers, according to PR Newswire.

Mandated by Congress, the Reportable Food Registry requires manufactures, processors, packers and distributors to report any safety problems with food for humans and pets, and animals. The reports help the FDA locate hazardous foods in the supply chain.

Notable cases so far include:

• In February 2010 – Hydrolyzed vegetable protein HVP was recalled, even though there were no reports of illness. More than 1,000 reports from industry on products with HVP led to the removal of 177 food products from store shelves.
• In November 2009 – Foods containing sulfites were recalled because they were not properly labeled. That led to the removal of two nationally distributed side dishes. Again there were no reports of illness.
• Salmonella was present in 37 percent of the 125 hazardous reports.
• Undeclared allergens were found in 35 percent of recalled food products.
• Listeria monocytogenes, a virulent food-borne pathogen and bacterium, made up 13 percent of reports.
• Among reports – There were 14 for animal feed or pet food; a dozen for seafood; 11 for spices and seasonings; and 10 for dairy products.

The legislation creating the food registry in 2007 requires industry to report any food for animals or humans that could reasonably present a probability of serious adverse health consequences or death. The reporting has to be done within 24 hours of the discovery of the problem and must be relayed to the FDA. Dietary supplements and infant formula do not have to be reported because they fall under a different mandatory reporting system. Also exempt are drugs and medical products or reports from consumers.

Interestingly any indication that a food product has been contaminated sparked a suspicion that it could be intentional, and the FDA must immediately notify the Department of Homeland Security. Florida food recall lawyers can help those who have experienced illness or harm from consuming contaminated food products.

Because the Food and Drug Administration’s Tobacco Control Act is one year old, it now has expanded powers. The Act was approved by Congress to keep kids from smoking and to help adults kick the habit. The FDA cannot regulate nicotine or outright ban smoking – a public health problem that kills 400,000 Americans every year – but it can chip away at Big Tobacco and its marketing intended to encourage young people to start smoking.

Big Tobacco knows if it can hook young people before the age of 19 that they are likely to become lifelong smokers.

It’s now against the law to sell cigarettes to anyone under the age of 18. Sales cannot be for anything less than a full pack of cigarettes. There can be no tobacco-sponsored events whether sporting or music.

One major tobacco consumer information point of concern is that the Tobacco Control Act now bans the industry from putting a positive spin on tobacco products and prohibited advertising or labeling tobacco products as “light”, “mild”, or “low”, and their promises of a lessened risk.

More and larger health warnings are going on smokeless tobacco packages.

Cigarette manufacturers will not be allowed to make or distribute flavored cigarettes such as fruit, spice, and candy-flavored, obviously aimed at hooking new smokers and they will not be allowed to market them to adolescent and teen smokers.

Part of the FDA’s expanded regulatory powers force cigarette makers to become more transparent, listing all ingredients, including toxins, added to tobacco.

Ironically, it is a user fee on tobacco manufacturers that is now funding the FDA crackdown on the industry.

Two drug safety reviewers believe that the diabetes drug, Avandia, should be removed from the market because of the drug’s link to thousands of heart attacks. Documents were released Saturday, February 20, the same day a report released by the Senate Finance Committee, suggest that drug maker, GlaxoSmithKline PLC, knew or should have known of the drugs’ dangers. The report also criticized the less than watchful eye of the Food and Drug Administration that is supposed to oversee drug safety.

Senators Max Baucus and Charles Grassley and their report suggests GSK understood there were heart risks associated with Avandia for several years, even before a study from the Cleveland Clinic suggested a link. The report suggests that Glaxo even went so far as to intimidate independent physicians and downplayed findings that a competing drug might be superior in reducing heart risks.

The report was compiled from some 250,000 documents, some supplied by Glaxo, the FDA and whistleblowers. Glaxo rejected the report’s conclusion.

Avandia had sales of 43 billion in 2006, but sales dropped off to less than half of that amount in 2009.

An advisory panel will be assembled by the Food and Drug Administration to assess the risks of Avandia, GSK’s second biggest seller. FDA Commissioner Margaret Hamburg says she is looking forward to that report.

FDA Reviews Are Not Favorable

Within the FDA, two reviewers in 2008 issued a memo that concluded Avandia’s risks exceed those of rival drug Actos, made by Takeda Pharmaceuticals. David Graham and Cate Gelperin wrote that as many as 500 heart attacks and 300 cases of heart failure were associated with Avandia use every month. Dr. Graham had argued to the FDA, as far back as 2007, that sales of Avandia should be halted.

If you or a loved one takes Avandia, you should know that in 2007, the FDA decided it should carry an addition warning about an increased risk of heart attack associated with its use when compared to a placebo. And even though the Cleveland Clinic researchers published a report warning of the heart attack risks, an FDA panel in 2007 voted 22-1 to keep it on the market.

When there is any doubt, the benefit of the doubt goes to the drug company and not the patient it seems. If you or a loved one have been taking Avandia and want to know more, consult with a Florida product liability attorney with experience in defective drugs. #

Source Article: http://edition.cnn.com/2010/HEALTH/02/20/avandia.study/index.html?eref=ib_topstories

The FDA reports that it is launching a new initiative to minimize damage from the ionizing radiation that comes from defective CT scans. Part of the campaign includes promoting personal medical imaging history cards. They will record the number of images one receives in a certain time period to minimize the cumulative number of radiation exposures. The initiative follows a series of reports from the Los Angeles Times that 260 patients were accidentally exposed to more than eight times the normal dose over a period of 18 months.

The FDA will hold public meetings March 30 and 31 to consider suggestions about further training requirements for CT scan operators. Also the groundwork must be laid for a national database to pre-determine the optimal dosage for any given procedure. The more radiation, the clearer the picture, but the manual override by operators is what has caused the overexposure problem. The use of CT scans has tripled since 1995 and many critics believe the review doesn’t go far enough. Up to one-third of the 70 million scans in the U.S. annually may be unnecessary. A 2007 study published in the New England Journal of Medicine, finds that up to 0.4% of cancers in the U.S. may be due to unnecessary scans. As it stands now, without a patient history card, it is up to the patient to remind medical technicians and their doctor of the number of scans they have received to avoid multiple, cumulative exposures.

Source Articles: http://abcnews.go.com/Health/CancerPreventionAndTreatment/fda-radiation-safety-standards-popular-rays/story?id=9795804

http://www.kaiserhealthnews.org/Daily-Reports/2010/February/10/FDA-and-medical-radiation.aspx

The Food and Drug Administration is debating whether to toughen warnings on tanning beds because of a suspicion they lead to cancer. The pitch for tanning beds has been that they are safer than lying in the sun and do not lead to cancer, but there is an increasing scientific consensus that there is no such thing as a safe tan, no matter what the source.

That is the message that one 18-year-old female received. She was preparing for the Miss Indiana pageant and getting a tan in a tanning salon when she discovered a growth on her leg. It turned out to be an early-stage melanoma, the most danger form of skin cancer. The woman had regularly gone to the tanning beds. It started in sixth-grade when she was a cheerleader. She even owned a tanning bed at one time. No more. She didn’t think the warning label on the tanning bed was meant for her. After all, it was so small, she said, “Nothing to make me stop and think, ‘This is real.’ The melanoma was caught before it spread further.

The World Health Organization has listed tanning beds as a definitive cancer-causer right alongside ultraviolet radiation. Both the sun and the tanning beds emit that form of radiation. Previously it was considered a “probable” carcinogen. The FDA recently decided those small warnings are not strong enough and do not convey the full message. So in March, an FDA advisory panel began public hearings to explore stricter regulations. UV radiation is also linked to basal and squamous cell carcinomas, which affect more than one million Americans a year and kill about 2,000 annually, while melanoma kills about 8,650 annually.

Source Article: http://cbs2.com/health/fda.tanning.beds.2.1433848.html

One of the big cries in health care reform is the need to have our medical information transferred to an electronic data base. The theory is that is patient records are accessible immediately and there will be fewer mix-ups in an emergency and during routine medical treatment. The government is so convinced this is a good idea that it plans to spend up to $27 billion on electronic medical records systems, also called health information technology, or HIT. Every American is supposed to have an electronic medical trail by 2014. But there are problems. Over the last two years, six patients have reportedly died and several were injured when the system malfunctioned. Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health testified at a government hearing on February 18 that there have been malfunctions of the system. HIT has mixed up patients, put test results in the wrong file, and lost medical information.

Other examples include a “locking up” of data in an operating room, and a failure to display a patient’s allergies due to software errors. The system is largely unregulated and the FDA may suggest some sort of framework of federal oversight which could include requiring the system makers to register with the government and submit reports on safety issues, errors and problems that surface. The systems could even face a pre-market review by the agency before they are launched. Sen. Charles Grassley says there needs to be a national system for reporting errors and product failures. Some manufacturers are resistant to additional scrutiny arguing regulation will not necessarily make electronic medical records safer, while others favor the stepped up scrutiny. Device makers also testified suggesting a patient safety organization be created to collect reports of problems in electronic health systems. Hospitals are interested too in finding out the most they can about safety flaws before they jump forward into the electronics age. After all, patient lives are at stake.

Savella is a drug used to treat fibromyalgia that should be banned says consumer group Public Citizen. The advocacy group has petitioned the Food and Drug Administration (FDA) calling for the Savella ban, pointing out that European regulators refused to approve it as a treatment for fibromyalgia.

What’s wrong with the drug? According to Public Citizen, in two clinical trials, Savella was found to increase blood pressure, heart rate and suicidal thoughts. Patients with normal blood pressure developed hypertension compared to those on a placebo. A hike in your blood pressure rate can increase the risk of a cardiovascular event, a heart attack or death.

Savella also carries an increase in the risk of seizures, addiction, mood disorders, excessive bleeding, glaucoma and gastrointestinal effects. Pregnant woman should not take the drug, says Public Citizen. And besides, says Dr. Sidney Wolfe of Public Citizen, as a treatment for fibromyalgia, it loses effectiveness after three months. With all of the downsides and few upsides, there is very little reason to take this potentially dangerous prescription medication.

And if there is any need for further convincing, the European Medicines Agency has rejected Savella’s approval for fibromyalgia saying its benefits were “marginal” and did not outweigh its risks. After this the FDA approved the drug in January 2009.

Source Article: http://www.bloomberg.com/apps/news?pid=20601103&sid=a0lZW4ldgHns