Compliance Resources to Help you Stay Current

Management acts on behalf of stakeholders and bring forth success for the company. When management fails to comply with its stipulated responsibilities, importance of following strong corporate-governance practices surfaces in order to protect interests of the stakeholders and to keep management in line.

Strict corporate governance results into superlative investment gains. Therefore, to fetching continual gains for the company and to creating ally between management and shareholders, practices such as independent board control, separation of the chairman and chief executive officer positions and appropriate compensation packages can prove to be useful.

For the patients of Alzheimer’s, Dimebon was perhaps the brightest ray of hope but that hope also got dashed when the drug failed in the last stage of the first clinical trial. Its failure not only demoralized its hopeful patients but also blown Medivation and Pfizer – the two companies which were dealing with the medicine.

Known as ‘metal on metal’ implants, this hip replacement procedure was one of the most admired one and has been opted for by about one-third of the approximately 250,000 hip replacements performed annually in USA, but result of this replacement has now set off an alarming bell amongst the patients and doctors. Recent researches have shown that this popular mode of hip replacement is causing severe pain, inflammation and death of tissues in the hip joint in some patients. Result of which is another surgery in two or three years to remove the implant.

Overstating or misstating the nutritional value of baby food, nuts and other products have irked FDA so much so that it has issued warning letters against 17 who’s who(s) in the food making industry including Nestlé and others. Labeling on a food product helps its buyers to understand the nutritional content of the food in an easier and a quicker way. Therefore, misstating or overstating can result into a serious health problem for the buyers. Keeping in mind the importance of labeling, FDA has issued warning letters against companies which have made false claims on their food packages and websites over trans fat content, antioxidant advantages, and omega-3 benefits that fail to meet the Food and Drug Administration guidelines. Not only overstatement, but additionally, these companies have masked the presence of a few contents like unhealthy fats in their product.

A broad array of products, starting from Gerber baby food, Juicy Juice, Dreyer’s ice cream to  POM pomegranate juice and Gorton’s fish fillets have received warning letters from FDA.

F.D.A. commissioner Margaret A. Hamburg has taken an exemplifying stand for improving information for consumers on food packages. Reinforcing her commitment to develop a clear, science-based labeling system that is effective with consumers, Dr. Hamburg has planned to issue draft guidelines for nutritional labeling and is ready to work with the food industry on a new labeling system. In an open letter to the industry, she has mentioned that while Wednesday's warnings are not indicative of labeling practices in the entire food industry, they should "give food manufacturers further clarification about what is expected of them as they review their current labeling”.

To know names of companies that have received warning letters from FDA, go to the below given link:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent

Source:

http://news.yahoo.com/

www.nytimes.com/

 

Opined by the keynote presenter of HIMSS 2010, Harry Markopolos, every year at least 20 percent of the current Medicare payments are going to fraudulent claims in US. Harry Markopolos, who is celebrated for exposing the ponzi scheme of Bernard Madoff, believes that health information technology is a double-edged sword in terms of finding fraud. He says “The EHR can make fraud easier to find, but also makes it easier to camouflage."

Unsafe food can transmit disease from person to person as well as serve as a growth medium for bacteria that can cause food poisoning and take lives of many. To avoid this situation, food regulatory bodies have passed different regulatory measures, which ensure that food safety has been properly taken care of before releasing a food item in market.

This article will discuss the increasing trend of protocol enrollment violations, how enrollment violations produces detrimental effects on premarket clinical trials, and how sponsors/CROs, sites and CRAs can help minimize future violations in an effort to increase subject safety and data integrity.

This article proposes a discussion about the development of Clinical Trials in Brazil, one particular country that integrates the “emerging market” for the Pharmaceutical Products.

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.

The Obama administration is making a push for tighter emission standards to control causing of smog. Driven by EPA's resolution to bring in stricter standards who have valued the Human Health Benefits at $13 billion to $100 billion by 2020 if all counties comply with the new standard. But industry expertes feel it is going to be additional cost burden to comply. The Bush administration had set the standard at 0.075 parts per million which was not well accepted by EPA scientific panel and environmental advocates who pushed for tighter standards. The new standards is likely to be set at 0.060 to 0.070 parts per million. The onus greatly falls on manufacturers, oil refineries and utilities to bear the cost of compliance.

A standard operating procedure consists of a set of instructions having the force of a directive, and covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. In clinical research, the International Conference on Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function".

SOPs are key to organizations involved in clinical research—whether pharmaceutical companies, sponsors, contract research organizations, investigator sites, ethics committees or any other parties—to achieve maximum safety and efficiency of the performed clinical research operations. Good Clinical Practices or Good Manufacturing Practices arises out of these SOPs. The risk of GMP non-compliance is high, where detailed SOPs are not available for reference. SOPs need to be updated regularly to ensure compliance. Regular training of staff will result in they appreciating the importance of SOPs and their role in meeting compliance requirements while manufacture and testing of drugs.

FDA issued warning letter to Nestle USA for observed violations under misleading labeling found on their Juicy Juice Products. FDA has observed that the labeling on the product is in violation of section 403(r) of the Act [21 USC 343(r)] and 21 CFR 101, 105 and 107. The labeling includes nutrient content claims which is not allowed or a food intended for use by infants and children less than 2 years of age. This is a case of misbranding of products as per FDA.

FDA issued warning letter to Freeman Manufacturing Company Corporation for faulty labeling of medical devices. FDA has observed that the content in the labeling is varying from their declaration in Pre-Market Approval. They have been also charged for going ahead with commercial distribution pending PMA without notifying the agency.

FDA issued warning letter to LSG Skychefs DEN 235 for violations under Interstate Conveyance Sanitation regulations (21 CFR Part 1250). FDA inspections have revealed high degree of ignorance towards the upkeep of their facility and have allowed pest infestation which results in adulteration and cause human health hazard. FDA has documented with evidence the violations and has issued notification to effect change of classification from approved to provisional.

FDA Issues warning letter to JFD Enterprises Inc. for violation of Current Good Manufacturing Practices Regulations. JFD Enterprices have been charged under serious violations of 21 CFR 110. The observations have been that food products churned out of their facility are adulterated due to lack of sanitation in their processes. Also additionally they are charged for violation of 21 CFR 101 which regulates labeling of products where the observation has that been of misbranding.

SEC has devised a final rule on Proxy Disclosure Enhancements which will enhance the information provided to shareholders so they are better able to evaluate the leadership of public companies. Good Corporate Governance is a result of proper accountability and accountability is impossible without transparency. In particular, the new rules require disclosures in proxy and information statements about:

• The relationship of a company's compensation policies and practices to risk management.
• The background and qualifications of directors and nominees.
• Legal actions involving a company's executive officers, directors and nominees.
• The consideration of diversity in the process by which candidates for director are considered for nomination.
• Board leadership structure and the board's role in risk oversight.
• Stock and option awards to company executives and directors.
• Potential conflicts of interests of compensation consultants.

All companies that have been awarded a GSA Schedule Contract need to implement a GSA Compliance System. GSA Schedule Contract stipulates the price offered to government and also poses restriction on price offered to customers buying outside the GSA Schedule Contract. It serves as a guidance for organizations to meet the reporting and governance requirements to comply with the terms of the contract. The companies are expected to be transparent in terms of all sales activities under the contract and maintain active registration with all government systems. GSA compliance can be established by designating clear lines of authority and accountability and measure performance against a specific standard.

Payment Application Best Practices was developed in 2005 by VISA to guide payment application developers that help merchants and agents mitigate compromises, prevent storage of sensitive cardholder data and support overall compliance with the PCI Data Security Standard (PCI DSS). The PCI Security Standard Council has ratified the PABP developed by VISA as a standard and has published the same as Payment Application Data Security Standard (PA-DSS). Under the PABP, 555 products were validated for compliance. Further PCI SSS has added to this list and has published the consolidated list in its website for smooth transition.

PCI SSC is in the process of adding a new provision to its existing PCI DSS mandate picked from PABP developed by VISA. This move by PCI SSC deems to bring in more security in payment application development. This will bring all the vendors of payment application development under the PCI DSS compliance umbrella.

Majority of the transactions in the recent times are cashless. The acceptance and use of the plastic money a.k.a credit/debit cards has seen a splurge in recent times. The convenience offered by these services has resulted in widespread acceptance of this form of money. This is only an end user perspective. Companies providing these services are striving to provide secure infrastructure for these transactions as there are possibilities of identity thefts which could be damaging both to the user and the provider.

Payment Card Industry Data Security Standard provides guidelines for companies that process, store or transmit credit card information maintain a secure environment. Though these standards were developed by PCI Security Standards Council, an independent body formed by major credit card brands, enforcing compliance is the responsibilities of the different payment brands and acquirers. The PCI DSS is a multifaceted security standard that includes requirements for security management, policies, procedures, network architecture, software design and other critical protective measures.