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"GPhA is pleased that the FDA has issued draft guidance today on the development of a regulatory pathway for generic biologic drugs, or biosimilars, as it is an important step in getting these affordable, lifesaving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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Xigris® (drotrecogin alfa , a synthetic version of protein C, which is a natural protein found in the body, was introduced in 2001. It was prescribed to treat patients that were diagnosed with severe cases of Sepsis and is used to reduce inflammation, decrease blood clotting, and break down current blood clots.
Sepsis, or blood poisoning, is a life threatening condition. This illness causes inflammation of blood vessels, blood clots, and may also lead to organ failure in severe cases.
Reports state that
federal health regulators are pleading with health care professionals to stop prescribing Xigris to patients that have been diagnosed with Sepsis. Researchers believe that the drug actually increases the risk of bleeding to death rather than reducing the risk.
In 2009, the Food and Drug Administration (FDA launched a review of Xigris due to a study which linked use of Xigris to a high rate of bleeding deaths. About 73 patients were reviewed, 20 of those patients were identified as having a risk of bleeding death, 7 suffered severe bleeding after taking Xigris, and 13 ultimately died. Since then, the FDA has advised doctors not to prescribe any new patients with the drug. The FDA also recommends that doctors ask patients that are currently using the drug to stop use immediately.
On Tuesday, October 25th, a
Xigris recall was announced due to the conclusion from a clinical trial which proved that the drug provides no benefits. Results showed that about 2% of patients prescribed Xigris survive septic shock compared to patients prescribed sugar pills. This trial studied 1,696 patients, half of which were treated with placebo. The FDA noted from this study that Xigris provides no significant benefits. The FDA has also suggested that all consumers that have purchased Xigris return the product back to its suppliers.
By Todd Neale, Senior Staff Writer, MedPage Today Published: February 08, 2012
Many of the adverse event reports involved patients who were elderly, had underlying medical conditions, or were taking broad spectrum antibiotics. All of those factors could have contributed to the greater risk of C. difficile-associated diarrhea, but the use of PPIs could not be excluded.
PPIs have been associated with other adverse events in the past, including
resistance to clopidogrel (Plavix ,
low magnesium levels resulting in a greater risk of leg spasms, arrhythmias, and seizures, greater risk of
osteoporotic fractures from chronic use, and
cardiac birth defectswhen used during pregnancy.
The FDA is also reviewing the possible risk of in C. difficile-associated diarrhea in users of another class of acid suppressing medications, the histamine H2 receptor blockers.
The Food and Drug Administration approved
Pradaxa use in October 2010. Shortly after, the agency received a number of reports that the drug causes adverse side effects which are both serious and often fatal.
Pradaxa (dabigatran is a medication designed to treat patients diagnosed with non-valvular atrial fibrillation. It is included in a class of drugs referred to as direct thrombin inhibitors that work by preventing an enzyme which causes blood to clot. When not treated, blood clots have the tendency to travel through the body to the brain and cause stroke which can in most cases lead to death.
Increased concerns associated with Pradaxa use caused the FDA to issue a safety communication in December 2011, warning the public and medical community about the risk of injury and other complications associated with Pradaxa.
Reported side effects of Pradaxa include internal bleeding, caused by the drug hindering kidney function leading to an excess of the drug spreading through the system, brain hemorrhaging, kidney bleeding, heart attack, and sometimes death. Of these, internal bleeding is the most serious. Symptoms of internal bleeding are listed on the
Pradaxa internal bleeding website.
No recall has yet been issued in the United States on the Pradaxa medication, however, the U.S., Japan, and Australian health officials have issued safety warnings on the drug.
The FDA is also in the process of reviewing a number of claims that
Pradaxa causes internal bleeding. In the meantime, Pradaxa lawyers have to represent victims injured by this potentially dangerous drug and are reviewing cases to file against Boehringer Ingelheim, manufacturer of Pradaxa.
Atrial fibrillation is a condition in which part of the heart does not beat the way it should. If not treated properly, blood cells may not circulate properly and tend to clot causing stroke and other complications.
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.
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."
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.
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