The US Food and Drug Administration is getting ready to review generic biotech drugs for the first time.
In advance of this, it released on 10 February 2012 guidelines under which the review process will be carried out. For consumers, the move represents the chance to obtain these hi-tech drugs - which presently command high prices - much more cheaply as so-called ‘biosimilars'.
The 2010 Patient Protection and Affordable Care Act featured one section calling for a biosimilar drug approval channel to open up but stated the FDA should be responsible for its content.
Draft Biotech Drug Guidelines
The draft biotech drug approval guidelines now release represent the administration's response to this call and they cover several areas. These include ‘Scientific Considerations', which supplies information to help generic biotech drug manufacturers prove that their products resemble those on which they're based. Also focused on are ‘Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product'.
"When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process", Janet Woodcock from the administration's Center for Drug Evaluation and Research explained in a statement. She added: "These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers."
Generic Biotech Drug Approval
Responding to the news of these generic biotech drug approval guidelines' release, manufacturers expressed content and a statement issued by GPhA - the Generic Pharmaceutical Association sums up their feelings.
"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients", the organisation said.
According to IMS Health, the worldwide biosimilars market has the potential to reach $25bn in value by 2020, thereby occupying a 10 per cent share of the overall biotech drugs market.
From here, the FDA's guidelines will be open for 60 days consultation, then firmed-up before being re-released in final form.
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The "Arsenic Prevention and Protection from Lead Exposure in Juice Act of 2012" or "APPLE Juice Act of 2012" is in response to a Consumer Reports investigation that found levels of arsenic and lead that exceeded the federal standards for drinking water in 10 percent of apple and grape juice samples tested in New Jersey, New York and Connecticut.
As the lawmakers note, both arsenic and lead are known to affect brain development in children. Both toxins are pervasive in the environment -- both naturally occurring and the result of pesticide use, emissions and other industrial and agricultural chemicals. In both cases, the federal government has set a safety threshold for drinking water but not for juice.
The APPLE Juice Act would require that FDA establish standards for fruit juices within two years.
"The unacceptable levels of arsenic and lead in juices currently sitting on shelves at the supermarket present a danger for our children and their health," said Pallone. "Setting basic standards for arsenic and lead in products whose consumers are primarily children is not only the right thing to do, it will help give parents the peace of mind that the juices their children drink daily are safe."
DeLauro, who often takes a lead on food safety issues in the House, said she was proud to join Pallone in introducing the bill.
"We must ensure that the juices our children drink are safe, particularly when 70 percent of the apple juice we consume comes from China," said DeLauro. "It is our job, and the FDA's job, to ensure the health and safety of the American people. This legislation will help to make that happen."
As the lawmakers noted in their announcement, though pediatricians often recommend that children limit their daily juice intake, 35 percent of children under five drink more juice than recommended.
"This bill will go a long way in protecting the public, especially children, from being exposed to these toxins. We're grateful for this effort to ensure the public's health and safety are protected," said Ami Gadhia, senior policy counsel for Consumers Union, the policy and advocacy division of Consumer Reports.
The bill comes just a few months after there was heightened public awareness about arsenic in the fall. Popular TV personality Dr. Mehmet Oz reported that some top-selling brands of apple juice were laced with high levels of inorganic arsenic. As Food Safety News reported then, most news reports were skeptical about the public health risk, especially after the FDA called the claim irresponsible.
Consumers, nonetheless, were concerned.
A few months after the Dr. Oz story aired, Consumer Reports released testing results that seemed to back up the claim that a small percentage of apple juice might have higher levels of inorganic arsenic than previously thought.
Consumer Reports tested 88 samples of apple juice and grape juice purchased in three states and found that 10 percent had total arsenic levels exceeding the federal standards of 10 parts per billion (ppb for arsenic in drinking water, and that most of the arsenic "was the type called inorganic, which is a human carcinogen." The tests also found that 25 percent of the juice tested had lead levels higher than the 5 ppb limit for bottled water.
The FDA says its "level of concern" for heavy metals in juices is anything above 23 ppb. The agency maintains that there is no threat to public health but testing has been stepped up.
"With respect to arsenic in apple juice, we're looking hard at whether we need a different, more stringent number to guide our action in regard to arsenic in juice," said Michael Taylor, Deputy Commissioner for Foods at FDA, in a recent interview with Food Safety News. "We need to be vigilant on these issues and I think we're making the right efforts to do that."
Controversial plans to build a US-style mega farm pose serious health risks to those living and working nearby, campaigners say
Controversial plans to build a US-style mega pig-farm in South Derbyshire close to a prison and residential housing pose serious health risks to those living and working there and could breach their legal rights to protection of their private and family life, the local council is being warned.
In the light of fresh legal advice, the organic farmers' group, the Soil Association and Friends of the Earth have joined forces with local group Foston Community Forum and
Pig Business, film-makers and campaigners, to urge Derbyshire county council to refuse planning permission for the proposed development at Foston.
Their challenge – the first against the scheme under the Human Rights Act – is
set out in a joint letter to the county council, stating that "planning authorities … have an obligation under the Human Rights Act 1998 to consider the effects of their decision on the human rights of affected third parties. The right to private and family life prevents not just physical incursions into the home or residence, but also interference from things such as noise, smell, emissions."
It goes on to say that the prison staff cannot avoid working close to the proposed development unless they resign from the jobs. The inmates of Foston Hall prison are not living in the area by choice, and clearly do not have the option of moving away if the development goes ahead. They will not be able to escape the risk to their health posed by the development, and the letter warns that allowing the pig factory to go ahead could also breach the inmates' right to be protected from inhumane treatment.
Midland Pig Producers (MPP has applied for permission to build the farm – which could house up to 25,000 animals – on a greenfield site west of the historic village of Foston and adjoining a women's closed prison which houses up to 290 prisoners. If approved, it would become the third largest factory farm in the UK, sending more than 1,000 pigs to slaughter every week.
The legal letter also cites new research which shows that intensive pig factories of this kind can adversely affect the health of nearby residents. This has been confirmed by the government's
Health Protection Agency (HPA , which says that those living within 150 metres of intensive pig farms "could be exposed to mutli-drug resistant organisms". The proposed development will be built within 150m of HMP Foston Hall - as well as within 75m of the nearest properties being planned for workers at the development site.
In November last year the project
was dealt a major blow when Derbyshire district council refused to back it. The final decision – already delayed – will be taken at county council level although no date has yet been set for a meeting.
After an application for a mega-dairy in Lincolnshire by Nocton Dairies,
which was later shelved, Foston has become the focus of a fierce fight over opposing visions for British farming. The Soil Association's concerns have been mainly about disease, antibiotic resistance and animal welfare in large pig herds.
But at an early stage the Foston battle took an unprecented twist involving libel law, when the Soil Assocation
received a threatening letter from solicitors Carter-Ruck - acting for MPP – saying its objection was defamatory and should be withdrawn.
Peter Melchett, policy director of the Soil Association, said: "The objections to the pig factory at Foston are mounting all the time, because of the growing weight of new scientific evidence of real risks to the health of local people, and to the staff and inmates of the prison right next door to the proposed site. Now it seems that the legal rights of local people may also be infringed by the proposed development."
Victoria Martindale, representative of the Foston community forum, said: "As a medical professional I am concerned about the health risks that this proposal will bring to local residents. Those living in the closest vicinity to the proposed site include the most susceptible and at risk groups such as children, the elderly and individuals already with known respiratory and other diseases. It is not fair to expect the residents of Foston to go about their everyday lives while being forced to continuously breathe in air that will put their and their families' health at risk."
A Derbyshire county council spokesperson said: "We have had thousands of views during the consultation and have had to look at and consider them. Following this, we have sent out for additional information from some agencies and are awaiting that. When this comes in we shall have to consider this and ensure we have all the information we need before compiling the report for the committee to consider."
MPP was contacted by the Guardian but has not issued a response to the letter.
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That Class I recall -- which the U.S. Food and Drug Administration defines as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death" -- was revealed this week as an item in the
FDA enforcement report for February 8.
Credit microbiologist and blogger Phyllis Entis for spotting what she calls a stealth recall, and explaining its significance on her
eFoodAlert website.
"I realize that not all recalls are created equal, and that not all recalls require public notification. But I cannot understand the rationale behind NOT publicizing a Class I Hazard recall of a ready-to-eat item of produce that may be contaminated with a potentially lethal pathogen," Entis wrote. "Would anyone care to explain this to me?"
The potentially contaminated spinach from Tiro Tres Farms of Eagle Pass, TX was distributed in Colorado, Kentucky, Massachusetts and Pennsylvania, and in Canada in Ontario and Quebec.
FDA and the Canadian Food Inspection Agency did not publish public notices of this recall in December or January - and still have not -- and the FDA enforcement report did not say whether there were any illnesses linked to the recalled spinach.
According to the enforcement report, Tiro Tres Farms notified its own customers of the recall by letter on Dec. 31, 2011, but the FDA report does not indicate if any of the spinach was sold by retailers.
The recall was of Robert's S 1 cut leaf "Curly" spinach packed in 30 lb. totes with no specific type of labeling, except for a small sticker label identifying the "pup" container that identified the harvest date and the field in Uvalde, TX. Harvest dates were Nov. 21, 22, 23, 25, 28 and 29, 2011, one month before the recall letter was sent.
The
Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up.
In a
letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said the agency will act to regulate e-cigarettes as tobacco products. To shore up its authority to do so, the agency will propose new regulatory language that would specifically define e-cigarettes as a tobacco product.
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