Tag Archive | "food and drug"

New Rules on Sunscreens Issued by FDA

The United States Food and Drug Administration announced on Tuesday that they will require new sunscreen labelling in order to identify the products that are best for decreasing the risk of skin cancer.

Based on the new rules, sunscreens that protect its users from UVA and UVB rays will be classified under “Broad Spectrum” sunscreens. FDA officials explained that both UVA and UVB rays cause skin damage; however, UVB rays are the main cause of sunburn.

Manufacturers of sunscreens will also be required to indicate sun protection factor (SPF). Those with less than SPF 15 could not claim that they help thwart sunburn, cancer, and premature skin aging.

The director of the Center for Drug Evaluation of the U.S. FDA, Dr. Janet Woodcock, said that sunscreens that meet their standards can now advertise their product as a tool that can help reduce the risk of skin cancer and early skin aging when used with other sun protection methods. The new labels, however, may not be seen until next summer, she added.

On the other hand, sunscreens with SPF of less than 14 and are not Broad Spectrum must indicate in their labelling that their product is not proven to decrease risks of skin cancer and sunburn. Woodcock also said that the said labels will be added on the drug fact box. She also said that sunscreens can no longer be referred to as “sunblocks” to avoid the impression that they offer complete protection from the harmful rays of the sun.


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Republicans Question Proposals to Push Healthy Eating Habits

Republican members of the House are pushing back against the administration’s efforts to promote healthy eating habits among the youth. They said that the Agricultural Department should tweak the rules they issued on January of this year that forces schools to make healthier lunches. Republicans insist that the ruling is far too costly.

The bill that was submitted by the Republicans further questions the Obama administration’s proposal to decrease the marketing freedom of unhealthy foods to the American youth. Moreover, they want the Food and Drug Administration to curb the rules requiring restaurants to place calorie count in their menus.

If the legislations proposed by the Obama administration will push through, it will cut billions from the FDA and USDA budgets, as well as domestic feeding programs.

Chris Crawford, a Georgia Republican, said that they are concerned about the costs of the administration’s proposals. Also, he said that the proposals may be overregulation. Although the regulation that controls the food products marketed to children is voluntary, a lot of companies are afraid that they may be penalized if they do not comply.

Crawford further said that the guidelines are “back-door-regulations”, pointing out the fact that children can watch violent and sexy TV shows but they cannot see an ad for child-friendly mascots like Tony the Tiger during commercial breaks.

On the other hand, Margo Wootan, a member of an advocacy group that fights for nutritional policies, said that the Republicans’ opinion on the matter is a very clear indication that the important benefits of nutrition policy are undermined.

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Avandia to be Pulled by FDA

The Food and Drug Administration has announced Thursday that retail pharmacies will stop selling the controversial oral diabetes drug Avandia starting November, because of the possible cardiovascular problems it may cause to patients.

Based on the new set of rules set by the FDA, Avandia will only be sold to patients who have been using the drug safely for a long time, patients whose blood sugar levels can only be successfully controlled by Avandia, and those patients who already know the risks the drug poses but still choose to use it. The rules will take effect on November 18, 2011.

Those patients who are qualified to take the drug or who will sign a consent stating he or she knows the risks and still willingly take the drug will be enrolled in a program. Only those who are enrolled in FDA’s special program will gain access to the drug.

Following the Avandia-Rosiglitazone Medicines Access Program, all medicines with rosiglitazone content will only be sold to enrolled patients. Certified pharmacies that participate in the program will release the drug by mail order. The agency said on Wednesday that GlaxoSmithKline – the drug manufacturer – will withdraw all rosiglitazone medicines from their supply chain. They will also provide pharmacies with specific instructions in returning the said medicines.

Rosiglitazone have other drug mixes such as Avendamet which is a combination of rosiglitazone and metphormine (hypoglycemic drug) and Avandaryl, a combination of rosiglitazone and glimeperide. These new FDA rules apply to all drug combinations of rosiglitazone.

GlaxoSmithKline spokesperson Mary Anne Rhyne announced that the company will inform doctors and pharmacists regarding the access program over the next two months; meanwhile, the company advices patients to discuss treatment options with their doctors first before making any changes.

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$93,000 Cost of Prostate Cancer Drug will be Paid by Medicare

Officials from Medicare already announced, Wednesday, that they will cover the $93,000 cost of Provenge. Provenge is a drug that is said to give men with end-stage prostate cancer four more months to live.

Medicare said that the drug manufactured by Dendreon Corporation is a very important drug and they want to ensure the drug will become accessible to a lot of men. Because of this, analysts said that Dendreon could sell up to $1 billion worth of the drugs. The decision will be finalized on June 30 and is said to be very important because most men with prostate cancer are 65 years old and above.

Naturally, Medicare covers drugs approved by the Food and Drug Administration. FDA cleared Provenge April 2010. Medicare’s decision to review coverage of the drug caused outburst from the public. They said that this is only the government’s way of avoiding reimbursing a costly drug.

Provenge is one of a kind as it is the first, and so far the only drug that utilizes the patient’s immune system to fight the cancer cells. Studies have shown that it can increase prognosis of prostate cancer by 100%. Moreover, it causes fewer side effects than chemotherapy.

Jim Kiefert, a prostate cancer patient, said that among all the treatments he had, Provenge had the least number of side effects. He further said that no one can put a price tag on human health, especially for a drug with very minimal side effects.

Bioethicists, however, argue that Medicare’s decision shows how bias the overall health care system in the U.S. is. Health care takes one fifth of the country’s economy only because the government tends to take pride in high technology, rather than going back to the basics.

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Menthol Cigarette Use has Increased Among Teenagers

Menthol cigarette use is particularly high among teenagers, as well as in young minorities, the government advisers informed as part of a draft report that was released on Monday.

The Food and Drug Administration advisers said further than 80 percent of adolescent smokers from the black race and further than half of adolescent smokers from the Hispanic race smoke menthol cigarettes.

The information was part of a draft chapter to be included in a report next week. The FDA will utilize the report to help determine whether or not the agency will ban or restrict the use of mint-flavored or menthol cigarettes.

Any restrictions to the use of menthol cigarettes will certainly affect the product outflow of Lorillard Inc, the top menthol maker that sells the cigarette brand Newport. Other companies that sell menthol cigarettes include R.J. Reynolds Tobacco Co of Reynolds American Inc, and Philip Morris of Altria Group Inc.

Based on the given data from Euromonitor International, menthol cigarettes account for almost one-third of the $83 billion annual cigarette sales in United States.

The draft also depicts that the increased usage of menthols among teenagers in general was brought by the remarkable increase in the quantity of white youths, aged 12 to 17, who are using menthol cigarettes.

The advisers will discuss their findings during a public meeting that will be held this Thursday and Friday. The complete report will be submitted to FDA on March 23.

Lorillard Inc has already filed a complaint that will prevent FDA from using the report given by the panel to make any official decision regarding the cigarettes.

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US FDA: 500 Unauthorized Prescription Drugs to be Pulled Out in the Market

The U.S. Food and Drug Administration said on Wednesday that it wants to pull 500 unauthorized prescription drugs for allergy, cold, and cough symptoms from the market because of the health risks they might pose to the public.

A list of 500 medications was released by the agency. The medications can only be obtained with a doctor’s prescription. However, the FDA has told drug companies to discontinue manufacturing those medications within 90 days and end shipping the items within 180 days.

Deborah Autor, FDA director of the Office of Compliance, Center for Drug Evaluation and Research, said that they do not know what those drugs are made of or how they are created. Also, they do not know if those medications will work properly.

She said close to if not all of the drugs are manufactured in United States. She said FDA believes many doctors continue to prescribe those medications. Some are even listed in desk reference books or advertised in journals.

Some of those drugs commonly used or sold in the market include Organidin, Cardec and Lodrane 24D. Another drug is called Pedia-Hist. The medication is not yet cleared by FDA, but it is already given to children as little as one year old.

Doctor Charlie Lee said the medications are chiefly a combination of cold and cough formulas. They have reported complications that include drowsiness, irritability and sedation.

FDA noted that the reports were still limited. It is not yet sure as to how many of the drugs were available on the market. Also, the number of people using the medication is still unknown mainly because most buy medications from the drugstore to treat the said symptoms.

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