Compliance Resources to Help you Stay Current

Zonegran is an FDA approved anti-epileptic drug, manufactured by the Irish company, Elan Corporation PLC. However, Elan and its U.S subsidiary promoted Zonegran for a variety of improper uses, including mood stabilization, migraine headaches, eating disorders and weight loss. It amounted to illegal promotion of the drug.  The Justice Department slapped a fine of USD 203 million plus on Elan Corporation PLC and its U.S. subsidiary under the False Claims Act. The Japanese drug marketer Eisai Inc., which bought the drug from Elan, will pay USD 11 million for off-label marketing of Zonegran.

Elan has consented to plead guilty and pay a criminal fine of USD 97 million and an additional USD 102.3 million to resolve civil allegations. It will forfeit assets worth USD 3.6 million too. The settlement demonstrates the government's determination to curb health care frauds by invoking the False Claims Act. The Justice Department claims to have recovered USD 5 billion plus since January 2009 in cases involving fraud against federal health care programs alone.

Regulations

The False Claims Act (31 U.S.C. § 3729–3733, also called the "Lincoln Law") is an American federal law that allows civilians to file complaints against federal contractors for filing fraudulent claims against the government. The act of filing such complaints is informally called "whistleblowing." Individuals filing under the Act stand to receive a portion (usually 15 to 25%) of any recovered damages. The Act provides a legal tool to counteract fraudulent billings turned in to the federal government. Claims under the law have been filed by persons with insider knowledge of false claims involving health care, military, or other government spending programs. The government has recovered nearly USD 22 billion under the False Claims Act between 1987 and 2008.

Source:  

http://www.pharmpro.com/news/2010/12/business-Elan-to-Pay-203M-Off-Label-Marketing-Fine/

http://en.wikipedia.org/wiki/False_Claims_Act

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., has voluntarily recalled all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews distributed in the United States. The recall was issued after the presence of foreign materials in the product, including metal and wood particles, was reported. The company’s investigations have led it to conclude that the materials possibly found their way into the product during its manufacture at a third party facility. The FDA has since suspended production of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews even as its own investigations into the matter continue. Production will resume once corrective actions are implemented. This recall was conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Although the risk of serious adverse health consequences is remote, McNeil Consumer Healthcare has advised consumers not to use the product by way of abundant caution. In particular, consumers who have medical concerns or questions should contact their healthcare provider.

Regulations

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203). It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals. It is designed to discourage the sale of counterfeit, adulterated, misbranded, sub-potent, and expired prescription drugs. The agency can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded drugs from the market.

Source:  

http://www.fda.gov/Safety/Recalls/ucm236715.htm

http://en.wikipedia.org/wiki/Food_and_Drug_Administration

Drug companies are not far behind tightening their control of faculty speakers, even as academic medical centers are facing the pressure to do the same.

Pharmaceutical companies have come under severe criticism as whistleblowers have launched lawsuits accusing them of using doctors to thrust their drugs/pills for non approved use over dinner conversations. The past three years has seen at least 10 companies settling lawsuits to the tune of approximately $7 billion. These companies have vowed to reform their ways as the threat of further punishment looms portentously.

Given this scenario, firms are now rigidly monitoring speakers. Seven companies are listed in ProPublica’s Dollars for Docs database – all of them are insisting that physicians use slide provided by the firm. This constraint is so designed as to fall in compliance with the U.S. Food and Drug Administration (FDA) regulations, necessitating speakers to discuss the approved uses of drugs only.

The contradiction comes with speakers violating universities’ policies if they follow the rules of the drug companies.

Dollars for docs

ProPublica is an independent, non-profit newsroom that produces investigative journalism in the public interest.

For many years, drug companies kept payment made to doctors to promote their drugs a secret. However, seven companies began to post the details of the same (name + compensation) on the internet, primarily due to legal issues/settlements. Ethical issues of the same rise even though receiving payment isn’t necessarily a wrongdoing.

A ProPublica investigation revealed that many doctors were paid speakers despite university bans, thus violating its policies. Compiled from disclosures by these seven companies, the discovery amounted to around $257.8 million in payouts since 2009 for speaking, consulting and other duties

A conflict of interest arises as academic medical institutions raise the issue of credibility of both the physicians and the institution they represent.

The new healthcare law

All drug companies will be required to publicly disclose payments to doctors as part of the new healthcare law by 2013.
 

Source

http://www.propublica.org/article/drug-companies-retain-tight-control-of-physicians-presentations

http://www.pbs.org/nbr/site/features/special/archives/pharmaceutical_companies/professors_violate_rules_accept_paid_speaking_roles_101220/

http://projects.propublica.org/docdollars/

http://www.propublica.org/article/dollars-to-doctors-physician-disciplinary-records

Tessalon (benzonatate) is an FDA-approved symptomatic cough relief drug for patients older than 10 years. However, this drug may attract younger children because of its candy-like appearance (round, liquid-filled gelatin capsule). The safety and effectiveness of benzonatate in children younger than 10 years has not been established. The FDA has therefore warned that accidental ingestion of Tessalon by children younger than 10 years can lead to serious side effects or even death.

In recent years, the FDA has uncovered a number of harmful products marketed as dietary supplements for sexual enhancement. These products actually contain active ingredients present in FDA-approved drugs or variations of these ingredients. Sexual enhancement supplements promising rapid or long-lasting effects are likely to contain the latter. The FDA has been urging consumers who have experienced negative side effects from such sexual enhancement products, to stop their usage and seek help from a health care professional.

The use of traditional medicine is widespread. Around the world, a number of people suffering from chronic and terminal illnesses, resort to traditional remedies. Standardized reporting could boost patient safety by identifying traditional treatments.

The Enterprise Knowledge Platform (EKP) from NetDimensions has updated a new version 6.3 of its learning management system. NetDimensions is a global provider of performance, knowledge, and learning management systems. The primary products developed by the company are the Enterprise Knowledge Platform (EKP), the Enterprise Assessment Platform (EAP) and the Enterprise Content Platform (ECP).

For decades now, doctors and health care providers have been eagerly awaiting safe and efficient weight-loss therapies. Numerous drugs have been launched so far and rejected by the FDA as they failed to meet the agency's criteria. Qnexa from Vivus Inc., and lorcaserin from Arena Pharmaceuticals Inc., are among the list of drugs that failed to gain FDA approval in recent times. Drug trials linked these drugs to potential heart problems, birth defects and cancerous tumors. Earlier this year, Meridia weight loss pill from the Abbott Laboratories stable was also recalled from the market after regulators said it increased the risk of heart attack and stroke.

McNeil Consumer Health care, Division of McNeil –PPC, Inc., in consultation with the U.S Food and Drug Administration (FDA) has recalled certain products. This is a voluntary recall of the following products:

All product lots of Children's BENADRYL® Allergy FASTMELT® Tablets (in Cherry and Grape Flavors) distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas.

As many as three pesticide distributors working in Washington State – Skyline Chemical, LLC, Axss USA and Pace International – will be fined more than $35,000 for the illegal import of pesticides as well as misleading labelling of products. These distributors will pay penalties violating the Federal Insecticide, Fungicide and Rodenticide Act.

On October 13, 2010, President Obama signed S 3397, the Secure and Responsible Drug Disposal Act of 2010. S. 3397 was considered on the House floor on September 29, 2010, under a suspension of the rules, requiring a two-thirds majority vote to pass. The Act was introduced by Sen. Klobuchar (D-MN) on May 24, 2010, and it passed the Senate by unanimous consent on August 3, 2010.   

March 31, 2010 is a day of joy for GSK as it receives EU approval via the Decentralised Procedure with Germany acting as Reference Member State for its prostrate drug, Duodart.

More on Duodart

Duodart is a fixed dose combination (FDC) of dutasteride and tamsulosin and promises to treat effectively the moderate-to-severe symptoms of Benign Prostatic Hyperplasia (BPH). Dutasteride is currently marketed as Avodart and tamsulosin, known as Flomax, is a generic drug marketed by Astellas Pharma.

Duodart, the once-daily dose medicine to treat the condition, will reduce the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH, says GSK.

During clinical trials, the combination therapy was well-tolerated and other than anticipated adverse effects such as erectile and ejaculatory dysfunction, any other effect has not been reported.

More on BPH

BPH, commonly known as prostate enlargement is a regular condition for men aged 51 and above.  Almost 40% men over the age of 65 suffer from the problem. Prostate enlargement takes place when its cells overgrow and start affecting the urine flow.

Men who have moderate BPH, experience symptoms interrupted sleep caused by nocturia, restricted daily activities caused by frequent and urgent need to urinate, anxiety, and fear of surgery and all these symptoms affect their quality of life, and also leave major adverse impact on close relationships.

However, GSK believes their medicine Duodart will successfully provide an impressive answer to minimize the problem of BPH.

Source:

http://www.pharmpro.com/News/FeedsAP/2010/03/gsk-receives-eu-approval-for-prostate-drug/

http://www.gsk.com/media/pressreleases/2010/2010_pressrelease_10036.htm

Natural Wellness is informing its consumers to restrain from buying or consuming its well known dietary supplement, MasXtreme Capsules, as the product contains undeclared drug ingredient.

30th march, 2010, FDA notified consumers about presence of undeclared amount of aildenafil and Phentolamine, an alpha-adrenergic blocker, in MasXtreme capsules which can cause adverse effects on human health.

Natural Wellness is informing its consumers to restrain from buying or consuming its well known dietary supplement, MasXtreme Capsules, as the product contains undeclared drug ingredient. On 30th march, 2010, FDA notified consumers about presence of undeclared amount of aildenafil and Phentolamine, an alpha-adrenergic blocker, in MasXtreme capsules which can cause adverse effects on human health.

The new healthcare legislation will bring a winning fortune for the big pharmas, believe analysts. However, their belief may get a toss as the ‘win’ of the two companies could be elusive to a large extent.

Healthcare Bill and Lifestyle Drugs

According to Pfizer and Merck, they cannot sell drugs to patients who do not go to doctors for treatments. Although cholesterol and diabetes cannot be labeled as medical emergencies, still without doctors’ approval, pharma will not be able to sell their drugs to the patients.

Now that the new healthcare legislation has increased opportunities for the insured people, analysts believe that the frequencies of doctor visits will increase visibly, which will result into increased selling of more lifestyle drugs like Pfizer’s Lipitor and Merck’s Vytorin. Moreover, manufacturing cost of most of the lifestyle drugs is extremely low compared to R&D and marketing expenses; increased volume could easily protect operating margins from lower prices. Therefore, profit will be on high for the big pharmas.

However, analysts’ beliefs may not prove right because insurance costs for both employees and individuals will continue to increase exponentially until 2014, so the number of insured could actually decrease in the short term. Additionally, generic competition from other companies will also increase by that time leaving a very small room for big pharmas like Pfizer and Merck for profit.

Healthcare Bill and Biological Based Drugs

In the new healthcare bill, patent protection of the biological based drugs has been extended which analysts find profitable for the pharma. But now scrutinizing this situation a little more can give a better picture. Development difficulties of these medicines coupled with government’s initiative to start doling out subsidies in 2014 will surely going to snatch the desired profit of the pharmas.

Therefore, still the question remains “how profitable is going to be the healthcare bill for the pharmas?” Let the coming days find out the right answer.

Source: http://seekingalpha.com/article/195143...

 

FDA is requiring the healthcare practitioners to temporarily stop using Rotarix vaccine, manufactured by GlaxoSmithKline (GSK) for rotavirus immunization in the US, as the FDA wishes to learn more about components of a superfluous virus detected in the vaccine. However, there is no evidence at this time that this finding poses a safety risk.


 

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

 

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.