French COVID testing product gets US emergency use authorization

PARIS - Biomérieux, a French healthcare company specializing in diagnostics, said on Monday it had won more positive feedback from the US Food and Drug Administration (FDA) regulator for its product aimed at helping test for the coronavirus.

BioMerieux said its 'BIOFIRE® RP2.1' panel testing product, which includes 22 pathogens that cause respiratory infections including SARS-CoV-2 which causes the COVID-19 coronavirus, had won 'emergency use authorization' from the FDA.

While the 'BIOFIRE® RP2.1' test has not had full clearance or approval from the FDA, the decision to give the product 'emergency use authorization' nevertheless marks more progress.

BioMérieux said it was looking to scale up supply of the BIOFIRE® RP2.1 panel at its production facilities in Salt Lake City (Utah, USA).

Test kits will be available for commercial distribution in the USA under the emergency use authorization, as well as internationally where regulatory approval allows.

BioMérieux added it expected to steadily build inventory levels to address the needs of the thousands of labs and healthcare professionals given an expected rise in demand for products aimed at testing for the presence of the coronavirus. 

-reuters-

Novartis, U.S. regulators agree to malaria drug trial against COVID-19

ZURICH - Novartis has reached an agreement with U.S. regulators to hold a randomized trial of generic malaria drug hydroxychloroquine against COVID-19 disease in 440 hospitalized patients, the Swiss drugmaker said on Monday.

The decades-old medicine has received U.S. Food and Drug Administration (FDA) emergency use authorization for coronavirus disease, but so far there is no scientific proof it helps those afflicted.

"We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis's top drug developer.

The drug, also used to treat lupus and rheumatoid arthritis, has been promoted by President Donald Trump, with some worried the administration's advocacy for an unproven medicine for COVID-19 has short-circuited the oversight process. (Reporting by John Miller, editing by John Revill)

-reuters-

Novartis $2 million gene therapy for rare disorder is world's most expensive drug

ZURICH/NEW YORK - Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million.

The Food and Drug Administration approved Zolgensma for children under the age of two with SMA, including those not yet showing symptoms. The approval covers babies with the deadliest form of the inherited disease as well as those with types where debilitating symptoms may set in later.

"This is potentially a new standard of care for babies with the most serious form of SMA," said Dr. Emmanuelle Tiongson, a pediatric neurologist at Children's Hospital Los Angeles who has provided Zolgensma to patients under an expanded access program. "The job now is trying to negotiate with insurers that this would be a long-term savings."

Novartis executives defended the price, saying that a one-time treatment is more valuable than expensive long-term treatments that cost several hundred thousand dollars a year.

Novartis touched off a debate over what gene therapy is worth last year, estimating its treatment would be cost-effective at up to $5 million per patient. A review in April by an independent U.S. group, the Institute for Clinical and Economic Review (ICER), concluded Novartis' value estimate for Zolgensma was excessive.

But on Friday, ICER said that based on Novartis' additional clinical data, the broad FDA label and its launch price, it believed that the drug fell within the upper bound of its range for cost-effectiveness.

Novartis said it was offering health insurers the option of installment payments for Zolgensma as well as refunds if the treatment does not work and upfront discounts for payers who commit to standardized coverage terms.

Novartis Chief Executive Vas Narasimhan has much riding on Zolgensma, describing it as a near cure for SMA if delivered soon after birth. But data proving its durability extends to only about five years. The therapy uses a virus to provide a normal copy of the SMN1 gene to babies born with a defective gene. It is delivered by infusion.

A RIVAL TO BIOGEN

Novartis is expecting European and Japanese approval later this year. Zolgensma will compete with Biogen Inc's Spinraza, the first approved treatment for SMA.

The disease often leads to paralysis, breathing difficulty and death within months for babies born with the most serious Type I form. SMA affects about one in every 10,000 live births, with 50 percent to 70 percent having Type I disease.

Spinraza, approved in late 2016, requires infusion into the spinal canal every four months. Its list price of $750,000 for the initial year and $375,000 annually thereafter was also deemed excessive by ICER.

Some neurologists see gene therapy becoming the preferred treatment for newborns with severe SMA, while acknowledging that families may choose to wait for long-term safety and efficacy data for Zolgensma. Novartis is looking into whether the death of one severely ill baby treated with Zolgensma was related to the therapy.

"Most families will want to do the gene therapy since it avoids the frequent spinal taps," said Dr. Russell Butterfield of the University of Utah in Salt Lake City. Butterfield has received payments from Biogen for consulting.

The FDA said it approved Zolgensma based on clinical trials involving 36 patients aged 2 weeks to 8 months. The agency said patients treated with Zolgensma showed significant improvement in developmental motor milestones such as head control and ability to sit up.

The most common side effects of Zolgensma are elevated liver enzymes and vomiting. The FDA is requiring Zolgensma's label to include a warning that acute serious liver injury can occur.

With additional studies underway, Novartis said it has so far treated more than 150 patients with Zolgensma, which was acquired with its $8.7 billion purchase of AveXis last year.

Wall Street analysts have forecast sales of $2 billion by 2022, according to a Refinitiv survey. Spinraza sales hit $1.7 billion last year, and are seen rising to $2.2 billion in 2022. Roche is developing risdiplam, an oral drug, for the condition and plans to file for approval later this year.

A PUSH FOR SCREENING

Novartis, Biogen and Roche, as well as patient advocates and neurologists, say babies with SMA who receive treatment before symptoms emerge stand the best chance of near-normal development. They are lobbying to make SMA screening standard for newborns in every market.

"Babies (with SMA) are losing motor neurons from the day they are born, so the ability to treat them as early as possible is the way you get maximum value out of the therapy," David Lennon, who heads Novartis' AveXis unit, said in a recent interview.

Dr. Laurent Servais, a child neurologist in Liege, Belgium, called any delay in implementing newborn SMA screening "completely unethical."

Servais helped oversee a screening pilot program sponsored by the three companies. Southern Belgium is now screening 60,000 newborns annually, half the country's total births. Taiwan has also begun testing babies for SMA.

But widespread adoption has a long way to go. In the United States, only six states have begun active and routine SMA newborn screening since the federal government recommended it in 2018. Patient advocates estimate it could take until 2022 for the testing to be implemented nationwide.

In Europe, it may be even slower.

England recommended against newborn screening in February and will not consider it again before 2021, a spokesman for Public Health England told Reuters. SMA advocates in Germany do not expect action on screening until late 2021.

"It's astonishing," said Inge Schwersenz, of the German Society for Neuromuscular Diseases. "But we can't do anything to speed it up."

source: news.abs-cbn.com

E. coli lettuce outbreak traced to California

NEW YORK, United States - An outbreak of E. coli linked to romaine lettuce appears to have been traced to crops in California, the US food authority said Monday. 

American consumers were warned against eating the leafy salad by health officials last week.

The outbreak has caused 43 people to become sick in the US and another 22 in Canada, according to the Food and Drug Administration (FDA).

"Our investigation at this point suggests that romaine lettuce associated with the outbreak comes from areas of California that grow romaine lettuce over the summer months," the FDA said in a statement.

"The outbreak appears to be related to 'end of season' romaine lettuce harvested from these areas," it said.

The harvest has now shifted to other areas and it was "critically important to have a 'clean break' in the romaine supply available to consumers in the US in order to purge the market of potentially contaminated romaine lettuce," the FDA said.

It added that the break in supply appears to have been accomplished after officials requested on November 20 that the produce be withdrawn from the market and destroyed.

On the same day -- two days before the Thanksgiving holiday when Americans gather and feast together -- the Centers for Disease Control and Prevention advised consumers not to eat any romaine lettuce and to throw away any they might have in their homes.

jum/wd/ecl

source: news.abs-cbn.com

US orders restriction on e-cigarette sales; youth use surges

TAMPA - US regulators Thursday ordered sharp restrictions on sales of e-cigarettes, as national data showed a 78 percent single-year surge in vaping among young people, with two-thirds using fruit and candy-flavored products.

The proposed regulations announced by the Food and Drug Administration (FDA) would allow flavored e-cigarettes products to be sold in stores only, not online, and would also ban menthol in cigarettes and flavored cigars.

The changes are open to a public comment period lasting until June before they can take effect.

"These data shock my conscience," said FDA Commissioner Scott Gottlieb, referring to the latest data from the National Youth Tobacco Survey.

"From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students," he said.

A total of 3.6 million US youths reported vaping at least once in the past month, the data showed.

"These increases must stop. And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes," said Gottlieb. 

The battery-powered devices heat a nicotine liquid that users inhale, and are gaining popularity in the United States and abroad, particularly among young people, which Gottlieb has previously described as an "epidemic."

The proposed rules aim to restrict sales of all flavored vaping cartridges -- other than tobacco, mint and menthol -- to sales at "age-restricted, in-person locations and, if sold online, under heightened practices for age verification," said an FDA statement.

The reason mint- and menthol-flavored e-cigarettes are not included is they are more popular with adults who may be using them to decrease or stop their use of traditional cigarettes.

"This reflects a careful balancing of public health considerations," Gottlieb said, citing data that shows mint- and menthol-flavored e-cigarette products "are more popular with adults than with kids."

At the same time, the FDA announced a proposal to ban menthol in combustible cigarettes and cigars.

"I'm deeply concerned about the availability of menthol-flavored cigarettes," Gottlieb said.

"I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes," he said, adding that "menthol products disproportionately and adversely affect underserved communities."

STOCKS SLIDE

Health experts applauded the FDA move.

"The banning of flavors, popular among teens, would definitely be an important step in curbing the growing epidemic of e-cigarettes among youth," said Patricia Folan, director of the Center for Tobacco Control at Northwell Health, a network of hospitals in New York.

Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said "it is widely recognized that e-cigarettes are the gateway to smoking tobacco cigarettes for teens and young adults."

E-cigarettes expose users to significantly lower levels of potentially toxic substances than traditional cigarettes, except for nicotine, the US National Academies of Sciences, Engineering and Medicine said earlier this year.

But Horovitz cautioned "there is a question of safety in e-cigarettes because of the presence of propylene glycol, and other as yet unidentified compounds."

Some e-cigarette makers have already taken steps to curb sales to young people, including JUUL, a fast-growing startup which announced Tuesday it is suspending in-store sales of various flavored products and scrapping its social media presence.

JUUL flavors such as mango, fruit, and creme will now only be available on the company's website, "where we are adding additional age-verification measures," a statement said. 

For its part, American tobacco giant Altria, maker of major brands like Marlboro and Chesterfield, said earlier this month it would stop selling 2 types of e-cigarettes that use "pods" of flavored nicotine liquid for refills.

Altria will maintain the sale of its other e-cigarettes -- which resemble conventional cigarettes and which come in traditional flavors like tobacco and menthol.

On Wall Street, tobacco stocks slid on the news, continuing a decline that began last week as media reports warned of the impending regulations.

Altria fell 1.86 percent at 1:45 (1845 GMT) while British American Tobacco (Dunhill, Lucky Strike, Pall Mall) lost 3 percent and Philip Morris International fell 0.26 percent.

source: news.abs-cbn.com

US approves Epidiolex, first marijuana-derived drug

WASHINGTON - US regulators on Monday approved the first marijuana-derived drug ever to hit the US market, Epidiolex, which will be used to treat 2 rare and severe forms of childhood epilepsy.

Made by the British biopharma company GW Pharmaceuticals, Epidiolex uses purified cannabidiol, or CBD, which is one of more than 80 active compounds in the cannabis sativa plant, often known simply as marijuana.

"This is an important medical advance," said US Food and Drug Administration Commissioner Scott Gottlieb. 

"But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use."

The drug is approved for use against Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older, the FDA said.

Both forms of epilepsy cause severe seizures.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others," said the FDA.

Like Dravet syndrome, Lennox-Gastaut syndrome also begins in childhood and causes multiple types of seizures. Most children affected develop learning problems, intellectual disability, delayed motor skills and need help with daily activities.

"For those living with intractable seizures caused by LGS and Dravet syndrome, Epidiolex represents a true medical advancement," said Philip Gattone, president and CEO of the Epilepsy Foundation. 

"Clinical development for these rare and severe conditions is essential, and today's news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures."

RECLASSIFICATION NEEDED 

Before the drug can be made widely available, the US Drug Enforcement Administration must reclassify CBD, which is considered a Schedule 1 drug that has a high risk of abuse and no medical value because it is derived from marijuana.

A reclassification is expected within 90 days, according GW Pharmaceuticals. The drug should be available in the coming months.

Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals.

The European Medicines Agency is currently reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo. 

Across the board, the drug was shown to be effective in cutting the frequency of seizures.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

An advisory panel to the FDA recommended in April that the drug be approved.

The FDA is not required to follow the advisory panel's advice but usually does.

CBD does not cause intoxication or euphoria. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC).

source: news.abs-cbn.com

Death toll rises to 5 in U.S. tainted lettuce outbreak

Five people in the United States have died after eating romaine lettuce that was contaminated with E. coli bacteria, whose source remains a mystery, officials said Friday.

A total of 197 people have fallen ill in 35 states, said the US Centers for Disease Control and Prevention.

Since mid-May, "four more deaths were reported, bringing the total to five deaths from Arkansas (1), California (1), Minnesota (2), and New York (1)," the CDC said in a statement.

The outbreak is the largest in the United States since 2006, when spinach tainted with a similar strain of E. coli sickened more than 200 people.

The latest batch of illnesses are believed to be linked to romaine lettuce grown in the Yuma, Arizona region.

However, the investigation continues and the US Food and Drug Administration has said "the illnesses associated with this outbreak cannot be explained by a single grower, harvester, processor, or distributor."

Romaine lettuce grown in the Arizona region was last harvested in mid-April.

"It is unlikely that any romaine lettuce from the Yuma growing region is still available in stores or restaurants, due to its 21-day shelf life," said the FDA.

Eating the contaminated lettuce may cause diarrhea, vomiting and even kidney failure in severe cases.

"Most of the newly reported cases are people who became sick two to three weeks ago, still within the window when contaminated romaine was available for sale," said the CDC statement.

"Some people who became sick did not report eating romaine lettuce, but had close contact with someone else who got sick from eating romaine lettuce."

Nearly half of those who became ill had to be hospitalized. A total of 26 people have developed a type of kidney failure called hemolytic uremic syndrome. 

source: news.abs-cbn.com

Menus with calorie counts now a must in US as Obama-era rule takes effect

WASHINGTON - +An Obama-era rule requiring thousands of US restaurants, stores and movie theaters to post nutritional information for items on their menus kicked in Monday, reminding Americans they are what they eat.

The calorie-labeling rules were a controversial provision of former president Barack Obama's signature 2010 health care law -- which President Donald Trump has pushed to dismantle -- and their implementation has been postponed several times.

But the Food and Drug Administration announced last year it would press ahead with the regulation, which requires chains with 20 or more locations as well as grocery stores and convenience chains to post calorie counts for standard menu items.

Many major restaurant chains like McDonald's and Taco Bell are already complying with the rule, but the federal government will now require it.

"National menu labeling could help make a big difference in America's obesity rates, one of our most vexing public health challenges," wrote FDA Commissioner Scott Gottlieb, citing research that menu labeling prompts consumers to order 30 to 50 calories less per visit.

A number of public health advocacy groups as well as the National Restaurant Association have lauded the move, but some industry organizations have lampooned it as inflexible and anti-business.

"Regrettably, FDA's one-size-fits-all approach demonstrates a stunning lack of understanding about consumer preferences and the pizza category," said Tim McIntyre, chair of the American Pizza Community, a coalition of pizza chains.

"Pizza's unique ordering variations create countless combinations making it difficult to accurately deliver information on printed menu boards and costly to maintain," he said in a statement.

But Gottlieb emphasized that the FDA has "worked hard to make sure this new rule can be implemented in a way where the information will be maximally beneficial to consumers and the new requirements will be minimally burdensome to restaurants and retail establishments."

"Firms won't need to deal with a patchwork of different requirements for calorie labeling across the country," he added.

Posters, billboards and coupon mailings are exempted, and supermarkets and convenience stores do not have to post calorie information next to each item in self-service buffets and drink stations, Gottlieb said last November.

More than a third of Americans are obese, putting them at higher risk for heart disease, diabetes and some types of cancer.

source: news.abs-cbn.com

Sanofi may seek U.S. approval for Dengvaxia

PARIS - Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines, a senior executive said on Wednesday.

David Loew, head of Sanofi Pasteur, the French drugmaker's vaccines division, said his teams had complied with all regulations regarding Dengvaxia and had no regrets about the way the product had been developed.

The Philippines, where more than 800,000 school-age children were vaccinated in 2016, suspended a vast public immunisation programme last year because of safety concerns.

Sanofi warned in November that the use of Dengvaxia was to be limited due to evidence it can worsen the disease in people who have not previously been exposed to the infection.

In February, a Philippine government agency filed a lawsuit against Sanofi, demanding compensation for the parents of a 10-year-old girl who the agency said had died as a result of receiving Dengvaxia.

Sanofi has repeatedly said it knew of no deaths resulting from the vaccine. While some experts have said the company and regulators might have ignored warnings about how the vaccine was developed, executives at Sanofi deny any wrongdoing.

"On the whole path of development, we always worked with the World Health Organisation (WHO) and experts in the dengue community. We were always transparent," Loew told Reuters in an interview, referring to the WHO and other regulators.

"You need to ask yourself: what was done with the information that was available at the time? Looking back, I would say no, we would not have done anything differently."

Mosquito-borne dengue is the world's fastest-growing infectious disease, afflicting up to 100 million people worldwide. It causes half a million life-threatening infections and kills about 20,000 people, mostly children, each year.

Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the U.S. Food and Drug Administration.

He also said Sanofi was holding discussions with external partners and universities to come up with a test which would be applicable before vaccination. Such a test would take at least two years to bring to the market.

"We operate in environments where the temperature is 30-40 degrees Celsius so you want to be sure that the tests resist (...) If you have a vaccination campaign taking place in a school for example, you want to make sure it is 'implementable,'" he said.

Dengvaxia has been approved and registered in 19 countries so far, mostly in the developing world. It is currently under review by the European Medicines Agency.

Sanofi booked an impairment charge of 87 million euros ($108 million) related to Dengvaxia in its fourth-quarter results.

Loew said the prospect of another financial charge this year was "extremely low."

source: news.abs-cbn.com

US bans antibacterial soap chemicals over health risks

WASHINGTON - The US Food and Drug Administration (FDA) on Friday banned several key chemicals in antibacterial hand soap, warning of health risks and saying they were not more effective than ordinary soap.

The FDA move took aim at 19 ingredients including the two most common, triclosan and triclocarban, which are widely included in liquid and bar antibacterial soaps despite fears they damage the immune system.

"Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Janet Woodcock, director of the FDA's drugs division.

"In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term."

The ban does not include hand disinfectant products used in hospitals and other medical centers, the FDA said.

Theresa Michele, who works with the personal care side of the agency, said most non-medical products on the market contain at least one of the banned ingredients.

Manufacturers have a year to comply with the ban, and some are already working to remove the ingredients in question from their products, the FDA said.

"Washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others," an FDA statement said.

If soap and water are not available, a hand santitzer "that contains at least 60 percent alcohol," could be used instead, it added.

Not all parties are convinced of potential harm from the personal care products, with the American Cleaning Institute (ACI) arguing that the soaps were safe.

"Antibacterial soaps are critical to public health because of the importance hand hygiene plays in the prevention of infection," an ACI statement said.

"Washing the hands with an antiseptic soap can help reduce the risk of infection beyond that provided by washing with non-antibacterial soap and water."

source: www.abs-cbnnews.com

PepsiCo brings back aspartame as diet cola sales fizzle

NEW YORK - PepsiCo said Monday it is putting aspartame back into some diet beverages in the United States, just a year after pulling the artificial sweetener from its products over consumer concerns about safety.

"Consumers want choice in diet colas, so we're refreshing our US lineup to provide three options that meet differing needs and taste preferences," a PepsiCo spokeswoman, Gina Anderson, said in an email to AFP.

The move comes as PepsiCo struggles with fizzling diet-cola sales.

Diet Pepsi's sales volume fell 5.8 percent in 2015 and dropped roughly 11 percent at retail during the first quarter of 2016, according to data from Beverage Digest cited by Bloomberg News.

The US beverages and snacks giant said in April 2015 it would replace aspartame-sweetened Diet Pepsi with versions sweetened with a blend of sucralose, commonly known as Splenda, and acesulfame potassium in August.

At the time, PepsiCo said that consumers wanted aspartame-free drinks. The trend came amid studies that linked aspartame to cancer.

But now American consumers appeared willing to mix up their artificial sweeteners, according to the company.

PepsiCo said it will use aspartame in its reintroduction later this year of Diet Pepsi Classic Sweetener Blend and PepsiMAX as PepsiZeroSugar.

Diet Pepsi, its main diet cola brand in the US, will remain sweetened with sucralose and Ace-K, it said.

Aspartame and sucralose are approved for human consumption by the US Food and Drug Administration.

In late 2014, Coca-Cola launched Coca-Cola Life, its first reduced-calorie soft drink sweetened with cane sugar and stevia leaf extract, a natural herbal sweetener.

source: www.abs-cbnnews.com

Company stops production of durian candy

DAVAO CITY -- The production of Wendy's Durian Candy was temporarily stopped after the sweets allegedly caused almost 2,000 school children in the Caraga region to fall ill.

The number of those affected by the food poisoning outbreak in the Caraga region has risen to 1,909, based on data gathered by the Department of Health (DOH) at 11 p.m. Saturday.

Janet Aquino, owner of Wendy's Durian Candy, immediately coordinated with the authorities after hearing about the incident.

"Noong nakita ko sa TV, pina-hold ko na iyong stocks ko upang 'di na madamay ang iba," Aquino said.

Officials of the DOH and the Food and Drug Administration (FDA) have also confiscated all their remaining stocks for testing.

According to Aquino, their candies have a shelf life of six months. She also denied that they sell expired products.

She believes that the candies sold to the students have been repacked, since they usually pack and sell their candies by the hundreds.

She also said the incident has deeply affected her business but she is willing to cooperate with the authorities on their investigation.

Davao City Health Officer Dr. Joy Villafuerte said Wendy's Durian Candy is not registered under the Bureau of Food and Drugs (BFAD). -- report from Claire Cornelio, ABS-CBN News Southern Mindanao

source: www.abs-cbnnews.com

FDA bares shortage of Pharmacists

Manila, Philippines --- The Food and Drug Administration (FDA) expressed concern that the Philippines lacks pharmacists, a problem it says hampers access of Filipinos to safe and affordable essential medicines.The FDA said there are 32,443 retail drug outlets in the country but there are only 20,000 registered pharmacists.

All drug outlets are required to be under the supervision of registered pharmacists, as mandated by Republic Act 5921 or The Pharmacy Law.

“The figure does not include 625 retail outlets for non-prescription drugs and 332 Chinese drugstores, 302 drug manufacturers, 45 medical device manufacturers, 412 drug traders, and 6,044 drug distributors, which also require the presence of pharmacists when open for business,” according to an advisory signed by FDA Director General Kenneth Hartigan-Go.

The FDA said it is concerned over the recent statement of the Philippine Pharmacists Association (PPhA) and the Drugstores Association of the Philippines (DAP) warning the public about drugstores that employ “ghost pharmacists,” or absentee registered pharmacists employed by unscrupulous drugstores.

PPhA Executive Vice President Dr. Yolanda Robles said that in the Camanava (Caloocan, Malabon, Navotas, and Valenzuela) area, for example, 70 percent of drugstore owners have no pharmacists.

The FDA said “it has initiated a series of activities to address ‘ghost pharmacists’ and acute shortage of dedicated community pharmacists that have severely affected the DOH delivery of public health goods and services and health outcomes.”

It said the lack of licensed pharmacists became evident when the DOH launched the Botika ng Barangay project in early 2000.

“The FDA faces the challenge, if not the dilemma, of ensuring all Filipinos have access to essential medicines down to the farthest barangay of the country with Section 27 of the Pharmacy Law and other rules and regulations, still in effect,” Go said.

The FDA said the Pharmacy Law’s provision of requiring a licensed pharmacist for every drugstore “may be a contributory factor that limits, if not hampers, the growth and expansion of the drug retails industry given the shortage in community pharmacists.”

In order to address this, “the FDA has taken steps to review the Pharmacy Law and its rules and regulations implemented by the FDA,” Go said.

Last October, the FDA told Health Secretary Enrique Ona “that there are existing legislations that may prevent full access to essential medicines and health products in the regions.”

“FDA will undertake several consultations with stakeholders, including the legislators and the civil society, to help find the balance and the solution that would best serve the interest of the public,” Go said.

The FDA is advising consumers to buy medicine from legitimate drug outlets. It warned drugstore owners to observe the provisions of Administrative Order No. 56, or the regulation that covers the licensing of drug establishments and outlets.

source: mb.com.ph

Toxic cosmetic products seized in Baclaran

MANILA, Philippines -- Over 100 boxes full of cosmetic products which allegedly contain toxic metals were seized by the Food and Drug Administration (FDA) from Chinese medicine drug stores in Baclaran, Parañaque City on Tuesday.

Members of the environmental watchdog Ecowaste Coalition initially posed as buyers of cosmetic products in drug stores surrounding the Redemptorist Church.

After the items were found to contain toxic metals such as lead and mercury, the FDA immediately confiscated the products.

The seized cosmetic products were not properly labeled, and did not provide understandable and adequate information.

The items are also included in the FDA's list of banned cosmetic products.

The FDA said if the drug stores are caught selling these products again, their business permits may be cancelled. -- Report from Zhander Cayabyab, dzMM

source: abs-cbnnews.com

FDA orders recall of 6 S.Korean noodle brands

MANILA - Philippine authorities have ordered the recall of six brands of South Korean noodles from local shops after they were reported to contain a cancer-causing chemical.

The Food and Drug Administration said in a statement dated Thursday that the noodles made by Nongshim Co, "will be off the shelves immediately", and called on the public to report if they were still being sold.

"The government is also undertaking inspection, collection and testing of other brands of noodles not currently identified to be contaminated as a precaution," the statement on the agency's website said.

The Philippine agency said its South Korean counterpart had found that the six brands contained "benzopyrene, a chemical with carcinogenic potential" in its tests.

The statement did not say if the Philippine agency had tested the Nongshim brands itself. Spokesmen of the local FDA could not be contacted for comment.

China, Taiwan and Vietnam have all reportedly had similar recalls of the same brands of South Korean noodles over similar health fears.

source: abs-cbnnews.com

Delays in new food-safety regulations cause frustration

Last year President Obama signed a law hailed as the most sweeping overhaul of food safety in 70 years. Fast forward 17 months, and major portions have yet to be implemented.

The Food Safety Modernization Act moves the Food and Drug Administration away from its traditional role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens. It allows the agency to issue mandatory recalls and hire more food-safety inspectors. The act passed with bipartisan support and broad backing from the food industry and consumer and public health groups.

The law will touch the vast majority of foods Americans eat. FDA oversees most of the nation's food supply, except for meat, poultry and processed eggs, which are under the U.S. Department of Agriculture.

But the new law hasn't gotten out of the starting gate. Regulations implementing the law are awaiting approval by the Office of Management and Budget, which is responsible for evaluating their effectiveness and making sure they are consistent with administration policies.

Three of the most important rules awaiting approval are:

•Safety standards for irrigation water, manure, worker hygiene and wildlife that can contaminate fresh fruits and vegetables.

•Foreign supplier verification programs that make importing companies responsible for the safety of the foods they bring into the United States.

•Requirements that food companies have a plan in place to identify possible sources of contamination and specify what they will do to deal with them.

By executive order, OMB is authorized to review new rules for three months and can extend the review period for an additional month. These rules have been at OMB for more than seven months.

OMB spokeswoman Moira Mack says public safety regulations can require extensive review. "The administration is working as expeditiously as possible to implement this legislation we fought so hard for. When it comes to rules with this degree of importance and complexity, it is critical that we get it right," she says.

Food-safety advocates and industry groups are frustrated.

"There is no good reason for this delay," says Erik Olson, director of food programs with the Pew Health Group, a part of the Pew Charitable Trusts. "What's important is that these new protections of our food supply be put into place as soon as possible to protect all Americans from getting sick from contaminated food."

"You really have to wonder who is advising the president to delay these regulations," says Caroline Smith DeWaal, food-safety director with the non-profit Center for Science in the Public Interest.

Polls show most people support food-safety legislation, she says. "It crosses party lines," she says. "People really understand that this is an essential function of government."

There's continued strong support from the food industry. Kraft, McDonald's, Coca-Cola, Kellogg, Walmart, Kroger, Cargill and Tyson are all on record as supporting the law.

Both the Grocery Manufacturers Association and the Produce Marketing Association sent letters to Obama this spring encouraging the administration to publish the draft rules.

Produce Marketing Association members handle more than 90% of fresh produce sold to U.S. consumers. In his letter, President Bryan Silbermann said not publishing the rules is creating "uncertainty and paralysis. It is much more difficult for companies to invest in additional food safety safeguards without knowing what the FDA rules will be."

Voters are willing to pay for food safety, according to poll by the Make Our Food Safe coalition, made up of 10 public health and consumer-advocacy organizations. Among likely voters, 66% support additional funding for FDA to carry out new responsibilities related to food safety. Almost 75% were willing to pay up to 3% more for food to cover the new safety measures.

source: USA TODAY

13 skin-whitening products containing excessive mercury being sold in Manila and Makati

MANILA, Philippines – Toxics watchdog Ecowaste Coalition on Wednesday alerted the Food and Drug Administration (FDA) on skin whitening products containing mercury that are being sold illegally in Manila and Makati.

Thirteen tested cosmetic products were found to contain excessive amounts of mercury. The products contained 550 parts per million (ppm) to 60,800 ppm of mercury. The ASEAN Cosmetics Directive's allowable limit is only up to 1 ppm.

Samples were purchased by Ecowaste from cosmetic stalls and Chinese drugstores around Binondo, Divisoria, Quiapo, and Sta. Cruz in Manila and Guadalupe in Makati. The products cost between P60 to P180. Ecowaste used an X-Ray Fluorescence spectrometer to measure the mercury content of the samples.

Mercury was not listed as an ingredient in all the samples and none of the skin whitening products had been previously listed in the 2010-2011 FDA list of 50 banned skinned whitening products containing excessive amounts of mercury.

Mercury is dangerous to humans in excessive amounts as this causes poisoning, mutations, and other health problems. Symptoms of mercury poisoning include irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around mouth. Mercury also damages the kidneys and the nervous system and interferes with the brain development of unborn and young children.

The group is urging cosmetic consumers to be wary of product labels and ingredients and not patronize those that do not give adequate and understandable information. It said products with mercury should not be thrown with ordinary trash.

Ecowaste sent a letter to FDA Officer-in-Charge Atty. Nicolas B. Lutero III proposing the following steps to address the issue:

a. Issue a new advisory banning skin whitening products for containing mercury above the allowable limit of 1 ppm.

b. Conduct a series of law enforcement activities to rid the market of skin lightening cosmetics containing dangerous levels of mercury and without the benefit of notification with the FDA.

c. Publish a consumer education material that will inform users about the health hazards posed by mercury-containing cosmetics.

d. Encourage victims of mercury exposure from skin whitening products to come forward and tell their stories.

Below are the results of the test conducted by Ecowaste on the 14 products:

1. AILKE Perfection Salvation Rosy Whitening and Peeling Cream manufactured/distributed by (not indicated on the label)(purchased for P120 from Central Chinese Drug Store, 1057 Ongpin St., Binondo, Manila), mercury NOT detected.

2. Feique Whitening Anti-Freckle Cream manufactured/distributed by GLDJB (Harbin) Cosmetics Ltd.,China (purchased for P60 from stall IA 43-45, 168 Mall, Divisoria, Manila), 16,000 ppm of mercury

3. Feique Golden Aloe Whitening Anti-Scar, Anti Freckle Set manufactured/distributed by GLDJB (Harbin)Cosmetics Ltd., China (purchased for P60 from stall IA 43-45, 168 Mall, Divisoria, Manila), 25,000 ppm of mercury

4. Feique Green Tea Vital Whitening Freckle-Removing Cream manufactured/distributed by GLDJB (Harbin) Cosmetics Ltd., China (purchased for P150 from stall IA 43-45, 168 Mall, Divisoria, Manila), 15,800 ppm of mercury

5. Bai Li Tou Hong manufactured/distributed by (not indicated in English) (purchased for P150 from stall IA 43-45, 168 Mall,Divisoria, Manila), 46,700 ppm of mercury

6. Maidaifu Herbal Moisturizing and Whitening Cream manufactured/distributed by (not indicated in English) (purchased forP180 from Stall IA-45, 168 Mall, Divisoria, Manila), 60,800 ppm of mercury

7. Green Cucumber and Ginseng 6 Days Specific Eliminating Freckle Whitening Set manufactured/distributed by Yudantang International, Taiwan (purchased for P120 from stall IR-24, 168Mall, Divisoria), 9,414 ppm of mercury

8. Loreial Paris Anti-Freckle Cream Suit manufactured/distributed by (not indicated on the label) (purchased for P120 from stall IB 2-4 999 Shopping Mall,Divisoria, Manila), 1,371 ppm of mercury

9. Aichun Beauty Strongly WhiteningFreckle Series (3 in one) manufactured/distributed by France Sasa (HK) International Group Ltd. / Livepro Beauty Cosmetics Co. Ltd., China (purchased for P98 from G2 Beauty Products, Villalobos St., Quiapo, Manila), 550 ppm of mercury

10. “Special Cream” (double, label in Chinese) manufactured/distributed by (not indicated in English) (purchased for P80 from stall G-162 Good Earth Mall, Bustos St., Sta. Cruz, Manila), 1,565 ppm of mercury

11. “Special Cream” (single, label in Chinese)manufactured/distributed by (not indicated in English) (purchased for P80 from Famous Chinese Drug Store, Recto Ave. near Rizal Ave., Sta. Cruz, Manila), 1,378 ppm of mercury

12. Yudantang Ginseng and Ganoderma Lucidum 6 Days Specific Eliminating Freckle Whitening Sun Block Cream manufactured/distributed by Yudantang International, Taiwan (purchased for P140 from Rose and Fujikura General Merchandise, Uni-Mec Supermarket, Guadalupe, Makati City), 31,300 ppm of mercury

13. Aichun Beauty Green Tea Whitening Speckle Removing Series (3 in one) manufactured/distributed by France Sasa (HK) International Group Ltd./Livepro Beauty Cosmetic Co. Ltd., China (purchased for P90 from G2 Beauty Products, Carriedo St., Quiapo, Manila), 1,250 ppm of mercury

14. Aichun Beauty Pawpaw Whitening and Freckle Remover Series (3 in one) manufactured/distributed by France Sasa (HK) International Group Ltd./Livepro Beauty Cosmetic Co. Ltd., China (purchased for P90 from G2 Beauty Products, Carriedo St., Quiapo, Manila), 867 ppm of mercury

source: interaksyon.com

Regulators clear Coke, Pepsi of cancer link

US regulators said soft drinks from PepsiCo Inc and Coca-Cola Co posed no cancer risk, contrary to a watchdog group that reported several popular brands contain high levels of a chemical linked to cancer in animals.

The Center for Science in the Public Interest (CSPI) said it found unsafe levels of a chemical used to make caramel color in cans of Coca-Cola, Pepsi-Cola, Dr Pepper Snapple Group Inc's Dr. Pepper, and Whole Foods' 365 Cola.

The group asked the Food and Drug Administration to ban caramel coloring agents that contain the chemical known as 4-methylimidazole, or 4-MI. This follows a similar plea last year.

"Coke and Pepsi, with the acquiescence of the FDA, are needlessly exposing millions of Americans to a chemical that causes cancer," said CSPI executive director Michael Jacobson. "If companies can make brown food coloring that is carcinogen-free, the industry should use that."

The FDA said it is reviewing the group's petition, but that the drinks were still safe.

"A consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents," said Doug Karas, an FDA spokesman, in a statement.

The cans were all taken from stores in the Washington, DC area, and some had levels of 4-MI near 140 micrograms in each 12-ounce can, the watchdog group said. The state of California has a legal limit of 29 micrograms of 4-MI, it added.

However, the group said a bigger health risk came from high-fructose corn syrup, which is used to sweeten soda and can contribute to diabetes.

The FDA's limit for 4-MI in caramel coloring is 250 parts per million (ppm). That caramel would then be diluted when it is put in soda. The highest levels of 4-MI found by CSPI were about 0.4 ppm, according to Reuters calculations.

"This is nothing more than CSPI scare tactics," the American Beverage Association said in a statement. "In fact, findings of regulatory agencies worldwide ... consider caramel coloring safe for use in foods and beverages."

source: interaksyon.com