Compliance Resources to Help you Stay Current

Recently FDA has shown “some concern” about bisphenol A or BPA for causing adverse effects on brain, behavior; and prostates of fetuses, infants, and young children and now, in the wake of FDA’s concern, EPA also is gearing to launch investigation about BPA’s effect on water supply and environment.

According to the FDA advisory system, there are five levels of concern of which “some concern” constitutes the third. Earlier, FDA faulted in judging the negative impacts of BPA on human health; only when hundreds of researches proved this chemicals’ relation with a number of diseases and disorders, FDA reversed its position and opinion about the chemical and marked it with “some concern”.

On 29th of March, 2010 EPA announced its planning for launching investigation against BPA. Interestingly, even on the report published by EPA on 30th December, 2009, BPA was not categorized as amongst first four deadly chemicals subject to more stringent labeling and monitoring. Incessant pressure from scientists and advocates may be viewed as the reason for sudden role reversal of the EPA.
 
However, EPA will initiate its investigation on BPA first by looking at the levels of presence of the chemical in ground water and drinking water. Also, the agency will “look for ways to reduce unnecessary exposures, including assessing substitutes”.

What is BPA?

BPA, the controversial chemical, is a plastic hardener used in polycarbonate manufacturing. BPA can commonly be found in food and beverage cans, CDs, paper receipts and in any other plastic products. BPA is mainly used for preventing leaks and contamination of canned foods. However, scientists believe that continuous intake of BPA may cause serious adverse effects on human health. Health problems associated with BPA are:

As the baby bottles contain BPA, infants may become prone to diseases caused by BPA and can’t get rid of the chemical

BPA can cause cancer, early onset puberty, obesity, and type-II diabetes

If consumed regularly, BPA can cause heart disease and liver-enzyme abnormalities

What Scientists Say

Over 900 peer-reviewed studies have found and established BPA’s negative effect on human health. Scientists believe retention of BPA in human body not only affects the particular human body but also affects future generations. Moreover, FDA standard for permissible BPA is also high and potent enough to cause serious damages.

An overwhelming number of reports on relation between BPA and human health, published or waiting to be published, affirm possibilities of significant disruption of endocrine system, cardiovascular disease, intestinal dysfunction, disrupted liver functioning, and disturbed chemotherapy treatment and so on.

Source:

http://www.newsinferno.com/archives/19440

http://www.newsinferno.com/archives/19451

http://current.pic.tv/2008/10/30/bpa-do-you-know-whats-in-your-plastic-bottles/

 

An advisory panel of the U.S. Food and Drug Administration has shown red signal to pixantrone as it failed to impress them.

The panelists unanimously agreed on the fact Pixantrone, Cell Therapeutics' (CTIC) lymphoma therapy, does not have adequate clinical data to support approval of the drug.

Single Clinical Trial – Was that enough for Pixantrone?

According to the Oncologic Drugs Advisory Committee, single that too an incomplete trail was not enough proof for the effectiveness of pixantrone in treating refractory aggressive non-Hodgkin's lymphoma.

Moreover, clinical trial done by the Cell Therapeutics managed to get only 140 out of 320 participants for clinical trial of the medicine.

Next Step for Cell Therapeutics

James Bianco, CEO of Cell Therapeutics said his company is “committed to working closely with the FDA to address the committee's comments as quickly as we can."

However, starting the process once again may not be very easy for Cell Therapeutics as generating new data to get approval from FDA will be a time consuming affair and will cost millions. Moreover, the company is already running on loss of $1.4 billion (as of December 31, 2009). Additionally, Novartis, its partner on the drug, is also withholding its option to license the drug, an event that would have delivered as much as $104 million in registration and sales milestones. Therefore, chance of Pixantrone to release soon is still in doubt.

Source:

http://seekingalpha.com/article/195948-fda-likely-to-deliver-blow-to-cell-therapeutics?source=feed

 

Declaration made by the Food and Drug Administration to hire a third-part inspector in order to keep up with quality-control standards, made shares of biotech firm Genzyme fell 4 percent to $55.25 in afternoon trading on Wednesday.

Tanning may cause skin cancer! That is what the FDA believes and hence, is working on issuing a new warning against tanning lamps and beds.



 

It’s a battle between FDA and the incessant problem of misleading food labels that has been affecting the live of Americans for last few years. This battle will take the form of war until FDA diminishing the deceptive labeling of food products. Defeating misleading food label is tough, but FDA also has made up its mind to cut the root of the problem as early as possible.
 

FDA has ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets.  FDA has already issued warning letters against these two companies requiring them to remove the unapproved tablets as part of the FDA's Unapproved Drugs Initiative1. Initiative 1 was announced in 2006 in order to address drugs that had not received FDA approval yet being marketed.

A good surgical mesh product helps to reinforce soft tissues at the place of weakness, but a fake surgical mesh can augment health complications for the patients. Being known to the fact, FDA has issued a warning against using counterfeit polypropylene mesh products that are being marketed under the C. R. Bard/Davol brand name in the U.S.

FDA has announced new boxed warning on Plavix. Plavix, which is an anti-blood clotting drug, can prove to be less effective in people who cannot digest the drug to convert it to its active form.

Plavix is one of the most effective medicines in terms of alleviating the risk of heart attack, unstable angina, cardiovascular death, and stroke in patients by making platelets less likely to form blood clots. Nevertheless, for its proper functioning, Plavix needs to be metabolized into its active form by the liver enzyme, CYP2C19.

The U.S. Food and Drug Administration (FDA) has teamed up with National Institute of Health (NIH) to pace up the process from scientific breakthrough to launch in market new and innovative medical therapies for patients.

Amylin and Alkermes are now sitting in suspense as the FDA deadline of approving their blood sugar controlling date is nearing. The drug manufactured by Amylin and Alkermes is coming with a revolutionary promise of transforming diabetes treatment with the first-one weekly injectable drug to control blood sugar.

Gone are the Days of Monitoring through Pinpricks

There was a time, when the diabetics used to take two shots a day and used to worry as much about the peaks and valleys of drug concentration in their bloodstream that they had to monitor through pinpricks.

Amylin with its top-selling drug, exenatide (Byetta) and biodegradable polymer from Alkermes, promised to produce a one-of-a kind drug which last longer in the blood thereby treating diabetes in a more efficient way. The drug has shown in clinical trials it can control blood sugar more effectively with just one shot a week, compared with the existing drug, which requires two shots per day.

Impact of the Drug

With FDA approval, the drug can potentially become Amylin’s (NASDAQ: AMLN) biggest sales driver for years to come. Alkermes (NASDAQ: ALKS), which has developed the technology to make the drug last an entire week in the bloodstream, has a 7.5 percent royalty on worldwide sales, without spending a penny on manufacturing or marketing.

The drug also has the potential of creating a deep impact on the on the diabetes epidemic. In a discussion that took place in January with Luke Timmerman, Amylin CEO Dan Bradbury told that he believes an estimated 25 million people in the U.S. have diabetes, and as the obesity epidemic rages on, the incidence of diabetes is expected to double over the next 25 years,

Moreover, according to the JP Morgan analyst Cory Kasimov, the drug has about an 85 percent chance of winning regulatory approval sooner or later, and could generate worldwide peak sales of $2 billion by 2017.

FDA Approval - Points to Note:

According to Luke Timmerman, whose opinion has come up on March 10, 2010 in Xconomy, there are four possible scenarios

—First, with a standard warning about risk of patients getting pancreatitis, the FDA could approve the drug.

—Second, the FDA may approve the drug but can issue a severe Black Box warning on the prescribing information that tells doctors about a risk that patients might get thyroid cancer.

—Third, according to Kasimov, with a “complete response” letter, the FDA can delay the exenatide once-weekly application. In that case, FDA will ask for a “minor” data from clinical trials that have already been done. However, for such minor request, companies can re-submit their application by the end of June, and has the chance of winning clearance for the U.S. market by the end of 2010.  

—Fourth, instead of minor “complete response”, the FDA can also issue a painful “complete response” letter saying that the drug needs additional data from an ongoing clinical trial, or that the drug needs to wait for long-term follow up to prove that exenatide has a beneficial effect on cardiovascular health of diabetes patients.

 Source:

http://www.xconomy.com/

This is a follow-up communication on the November 10, 2009 Dear Healthcare Professional letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs. The letter updates the FDA/CDC experience with the H1N1 vaccination program and provides some detail on the current vaccine safety monitoring program.

Ranbaxy has recalled its acne treatment drug Sotret for the second time owing to some descrepancy in the specifications. This is deemed as more of a voluntary and precutionary move as per the FDA class III procedure. In 2008, FDA had banned this drug owing to GMP deviations observed in Ranbaxy production plant in Himachal Pradesh. Ranbaxy was recently bought over by Japanese DaiiChi Sankyo who were surprised by the observation of filing untrue data by Ranbaxy with the FDA. Both the companies are cautious that this will not derail their ongoing efforts of reversing the ban in the US. Since the ban, the drug has lost heavily in the US market in terms of revenue.

A coordinated effort between the FDA’s Office of Criminal Investigation, Centre for Drug Evaluation and Research and Office of Regulatory Affairs resulted in issuance of 22 warning letters to operators of websites who were indulged in illegal sale of unapproved and misbranded drugs. With this internet service providers and domain name registrars will be able to terminate websites and domain name usage.

Compliance is a necessary evil. But knowing the high cost of non-compliance, it is a worth while effort to be compliant. Compliance augments brand value. It attracts new customers and helps maintain longstanding relationships with existing customers. Regulatory compliance works for the benefit of the society, protecting stakeholder interests. So, how do you prepare for it?

• Understand the implications of compliance on company health
• Communicate well with all involved
• Discovery – Research on the existing regulations
• Select the appropriate one for your type of industry
• Identify tools and vendors who can elevate efficiency

“House Passes Health Reform Bill” read the headlines a couple of days back. Obama’s landmark project set to bring radical change in medical coverage to the entire population of America. Pro-Obama group are all praise for the outcome. But there are also voices which raise concerns about the fine print of the bill. So does government regulation prove to cause more harm than good?

Regulations have been conceptualized to reign in quality, costs and any kind of malpractices that can affect the users. Quality comes at a cost. The cost of compliance is very significant. Hence regulations are termed as necessary evil. Truth is the cost of non-compliance could be higher.

FDA applies different regulatory requirements on products depending on whether they are medical devices, drugs or biologics. FDA has instituted various agencies to govern, enforce and update these regulations. But FDA has found it challenging to regulate products which are a combination of the categories.Though FDA has done well in regulating such products, industry feels the need for improvement in this area. Compliance is the need of the hour, but being compliant requires investment of time, resources and budget.

This article discusses the current approach in regulating combination products, problems with the current approach and the new developments in this regard which will make regulating these products more transparent, consistent and appropriate.

FDA has made a startling discovery that about 50,000 hospitalizations reported could be avoided if caregivers took extreme care whie administering prescription medicines. The cost perspective has been estimated to be $4billion annually. The concern here is that most of the victims are children of all ages.