Compliance Resources to Help you Stay Current

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.
 

The historic health care bill has resulted in U.S. debt price rise.

The benchmark 10-year note rose 9/32 to 99-23/32 and its yield fell to 3.664%. The 30-year bond rose 4/32 to 100-27/32 and its yield fell to 4.63%. The 2-year note rose 1/32 to 99-26/32 with a yield of 0.98%. The 5-year note rose 8/32 to 99-27/32 with a yield of 2.41%.

Continued crisis of Greece and other European countries, commonly known as ‘PIIGS’ is also fueling the demand of dollar dominated assets like Treasurys. Kevin Giddis, president of fixed income at Morgan Keegan believes that the PIIGS debt crisis will pass eventually, but as long as the near-term outlook for European economies remains cloudy, "I would hate to be a seller of Treasurys at these levels,".

Source: http://money.cnn.com/2...campaign=Feed%3A+rss%2Fmoney_markets+%28Markets%29

 

The Senate Finance Committee is initiating an investigation to delve into patient safety and quality of care provided by long-term care hospitals.

The National Institute of Health (NIH) has announced its new initiative of creating a Genetic Testing Registry to create a public database available for researchers, consumers, health care providers, and others looking for information. This database will contain information submitted by genetic test providers voluntarily.

At present, although there are more than 1,600 genetic tests are available to patients and consumers, but lack of public resource providing detailed information about them makes the genetic testing unavailable for the patients and consumers. GTR is an initiative of the NIH to fill the gap and it has been developed in order to enhance access of common people to information about the availability, validity, and usefulness of genetic tests.

Released in December 2009, the ‘Pay-to-Play’ rule of SEC was intended “to ensure that the high standards and integrity of the municipal securities industry are maintained, to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to perfect a free and open market and to protect investors and the public interest by: (i) prohibiting brokers, dealers and municipal securities dealers from engaging in municipal securities business with issuers if certain political contributions have been made to officials of such issuers; and (ii) requiring brokers, dealers and municipal securities dealers to disclose certain political contributions, as well as other information, to allow public scrutiny of political contributions and the municipal securities business of a broker, dealer or municipal securities dealer.”

In an announcement made on March 18, 2010, SEC clarifies that the municipal securities rule of pay-to-play does not only apply to just a firm's employees, rather affiliated financial firms also come in its purview.  

According to the pay-to-play rule, MSRB Rule G-37, firms should restrict themselves from underwriting municipal bonds for an issuer for two years after a municipal finance professional (MFP) involved with that firm makes a campaign contribution to an elected official of that municipality.

In fact, as per the rule, an investment adviser who makes a political contribution to an elected official in a position to influence the selection of the adviser can be barred for two years from providing advisory services for compensation, either directly or through a fund.

However, through its Report of Investigation, SEC clears that any executive supervising the activities of a broker, municipal securities or dealers will not be exempted from MSRB's pay-to-play rule just because he or she may be outside the firm's corporate governance structure.

Source:

http://www.sec.gov/news/press/2010/2010-42.htm

http://www.sec.gov/news/press/2009/2009-168.htm




 

Recently in a newspaper article, one of the best investigative reporters in china revealed that counterfeit vaccines have taken lives of four children and making another dozens of people sick.

Over the last few years, China has been weighed down with a series of accusations of producing counterfeit medicines thus raising questions against its government’s will to safeguard patients’ safety in the country.

Sterilization validation is a topic of immense relevance as it pulls many audit observations from the FDA and international regulatory bodies. For medical device sterilization, comparing to other modes such as steam sterilization and etc, EO works in relatively low pressure temperature and therefore, has been regarded as one of the most excellent and useful method of medical device sterilization.

What is International Financial Reporting Standards for SMEs?

Promulgated and published by the International Accounting Standards Board on July 9 2009, the International Financial Reporting Standard (IFRS) has been designed for the use by small and medium-sized entities (SMEs).

Goal of IFRS for SMEs is to provide a modified and simplified version or interpretation of full IFRS so as to meet the needs of private company financial reporting users and provide a cost-benefit approach for easing the financial reporting burden on private companies. Known as a self-contained global accounting and financial reporting standard, IFRS for SMEs is applicable to the general-purpose financial statements of, and other financial reporting by, entities that in many countries are known as small- and medium-sized entities.

The standard is an outcome of five-year development process with extensive consultation of SMEs, which represent more than 95% of all companies worldwide.

What are Small- and Medium-Sized Entities ("SMEs")?

SMEs are entities that publish general purpose financial statements for external users and do not have public accountability. According to IASB’s definition, an entity has public accountability when it files, or is in the process of filing, its financial statements with a security commission or other regulatory organization for the purpose of issuing any class of instruments in a public market. Additionally, it bears accountability in case it holds assets in a fiduciary capacity for a broad group of outsiders. For instance, entities banks, insurance companies, pension funds, brokers and dealers in securities, and mutual funds hold assets in a fiduciary capacity.

IASB has developed IFRS for SMEs keeping in mind the necessity of accounting framework for entities that are small or medium in size and lack the resources to use full IFRS. In fact, in the United States, the term "SME" can cover many private companies.

How International Financial Reporting Standards for SMEs will Help SMEs

IFRS for SMEs promises to help small and medium sized companies to be more focused on shorter-term cash flows, liquidity, balance sheet strength, interest coverage and solvency issues.

While the full IFRS becomes a burden on SME preparers with its varied and extensive topics and detailed implementation guidance that generally are not relevant to SMEs, the IFRS for SMEs are more to-the-point and handy for the SMEs in terms of balancing the costs and benefits from a preparer perspective.

With IFRS for SMEs, many SMEs around the world, including private companies in the United States, will have the option of using a much simplified, IFRS-based accounting framework to prepare their financial statements.

To know more about IFRS for SMEs, join the webinar International Financial Reporting Standards for SME's . Register yourself for the webinar and become acquainted with the latest information regarding IFRS for SME’s and will include an opportunity to practice applying these standards.

 

Toyota is surely going through its roughest phase! This time flaws in an electronic system forcing Toyota to fix nearly 1.2 million Corolla and Matrix models.

Since November 2009, NHTSA (National Highway Traffic System Administration) has received 26 stalling complaints in Corolla and Matrix models where drivers reported the stalls happened randomly and could have caused fatal accidents. Although Toyota disapproves the potency of the alleged defect to create “an unreasonable risk to motor vehicle safety”, but the U.S. safety regulators and members of three congressional panels have criticized Toyota for moving too slowly to address consumer complaints of unintended acceleration and other safety concerns.

Recently Toyota went through a rough phase when it had to recall 8.5 million of its vehicles due to acceleration and engine problem. Now with the flaw of electronic system, Toyota will again come under the scrutiny of US regulatory bodies.

Source: http://www.reuters.com/article/...

 

A recent study, done by Medco Research Institute and Mayo Clinic, shows that by using warfarin genetic hospitalization rates have been dropped by almost 30%. At the American College of Cardiology's 59th annual scientific session, results of the first nationwide prospective study examining end products of incorporating genetic testing into the management of warfarin as part of the usual care of patients were presented today.

Warfarin and Its Challenging Aspects

Warfarin, marketed under the brand names Coumadin® and Jantoven®, may prove to be challenging given variable drug response between individuals. Additionally, because of its narrow therapeutic range: doses that are too high or too low can lead to bleeding or clotting complications, respectively. It is anticipated that up to 20 percent or more of patients can be hospitalized for bleeding within six months of starting warfarin. Finding its association with severe health hazards, the US Food and Drug Administration issued a black box warning on warfarin labels outlining such risks and recommending close patient monitoring. The new the labeling now refers to a table outlining recommended doses for individuals depending on their CYP2C9 and VKORC1 genotype information.

What Medco and Mayo Found

Medco and Mayo initiated this study in July, 2007 with patients from 49 states. Patients even got insured by dozens of health plan sponsors managed by Medco.

In a study of comparison 896 individuals who received genetic testing for CYP2C9 and VKORC1 genes early in their warfarin treatment were compared with 2,688 control individuals, selected from the same group of health insurance sponsors the previous year, who had received treatment without genetic testing.

Patients participated in the study ranged from 40 to 75 years old, with an average age of 65 years, of them around 60% were men. Genetic testing for the study was performed at the Mayo Clinic, which also gave doctors guidelines for applying genetic information to drug dosing and management. The researchers found that those in the genetic testing group were 28 percent less likely to be hospitalized for bleeding or thromboembolism — and 31 percent less likely to be hospitalized for any reason — than individuals in the control group, based on medical claim data.

Impact of the Study

Conducted in national "real world" settings, this comparative effectiveness study validates that testing for an individual's unique genetic predisposition can significantly improve warfarin's safety and effectiveness by providing information about the patient's sensitivity to the drug.  

According to the lead author Robert Epstein, Medco's chief medical officer and president of the Medco Research Institute "These results show that we can greatly reduce hospitalizations, and their significant costs, by making genetic testing routine early in a patient's therapy with warfarin, If it costs a few hundred dollars for the genetic test but avoids the $13,500 hospital bill, it very quickly pays for itself."

What Others Say

However, Mandeep Mehra, chief of cardiology at the University of Maryland Medical Center, presented his own view at the ACC meeting that the study of the Medco/Mayo study could provide a better result if physicians followed those patients more closely instead of making them genotyped.

Source:

http://newsblog.mayoclinic.org/...warfarin-genetic-test-cuts-hospital-admissions
http://medco.mediaroom.com/index.php?s=43&item=428
http://www.genomeweb.com/...warfarin-genetic-testing-decreases-hospitalization

 

Grand River Hospital District (GRHD) has an exciting program to offer to women, the Women's Wellness Connection.

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.

Facilitated health information exchange and advance health information technology can result into improved health care.

Acknowledging the same fact, Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, has announced awards to help states facilitate health information exchange and advance health information technology (health IT).

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.

Now your issue/complaint with the facility will 100% be taken care of. This assurance is coming Ralph Montano, spokesman for the California Department of Public Health, which regulates hospitals and long-term care facilities in the state.

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.

Published on 15 November 2009, ISO 31000:2009 stands for Risk Management – Principles and Guidelines. Goal of the ISO 31000 standard is to provide a framework to guide organizations in their risk management process. It seeks to integrate this process into the organization’s overall governance, strategy and planning, management, reporting processes, policies, values and culture.

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/

The Medical Records Database for Patients in England has come under fire of criticisms recently. Although the plan was built for organizing online appointments system and e-prescriptions in a hassle free way and also to maintain record of 50 million patients, its repeated criticism over security has left many concerned about using the plan.