FDA permits marketing of first test for most common cause of gastroenteritis outbreaks

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.

Norovirus is a leading cause of food-borne disease outbreaks in the United States.

Acute gastroenteritis is an inflammation of the stomach and intestine that can cause diarrhea, vomiting and stomach pain. Norovirus contamination usually occurs in settings where there is close group contact, such as cruise ships, hospitals, long-term care facilities, and schools or child-care centers. It is a highly contagious virus that spreads rapidly through direct person-to-person contact, contaminated food or water, and by touching contaminated surfaces.

“This test provides an avenue for early identification of norovirus,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Early intervention can halt the spread of an outbreak.”

The test is not sensitive enough for use when only a single person has symptoms and should not be used for diagnosing individual patients.

The manufacturer demonstrated the performance of the Ridascreen test by comparing results of it to the results of a norovirus reference standard for 609 fecal samples. When the fecal samples were tested with Ridascreen, overall results on average were less sensitive than those of standard reference tests, detecting norovirus across samples about 2/3 of the time it was present.

The FDA reviewed data for Ridascreen via the de novo pathway, an alternative path to market for devices that are lower risk and may not require premarket approval (PMA), but are of a new type, and therefore may not be able to be cleared in a '510(k)' premarket notification.

In March, the U.S. Centers for Disease Control and Prevention will be updating management and disease prevention guidelines for norovirus outbreaks. These guidelines will likely reflect substantial advances made in norovirus epidemiology, immunology, diagnostic methods and infection control.

Ridascreen is made by R-Biopharm AG, located in Darmstadt, Germany.

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Pharmaceutical Giant AstraZenaca to Pay $520 Millionj for Off-Label Drug Marketing

AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and
effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services' Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as "off-label" uses because they are not included in the drug's FDA
approved product label.

The Wilmington, Del.-based company signed a civil settlement to resolve allegations that by marketing Seroquel for unapproved uses, the company caused false claims for payment to be submitted to federal insurance programs including Medicaid, Medicare and TRICARE programs, and to the Department of Veterans Affairs, the Federal Employee Health Benefits Program and the Bureau of Prisons.

Under the terms of the settlement, the federal government will receive $301,907,007 from the civil settlement, and the state Medicaid programs and the District of Columbia will share up to $218,092,993 of the civil settlement, depending on the number of states that participate in the
settlement. The allegations were originally brought in a lawsuit under the qui tam or whistleblower provisions of the False Claims Act and various state False Claims Act statutes.

Under the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Before approving a drug, the FDA must determine that the drug is safe and effective for the use proposed by the company. Once approved, the drug may not be marketed or promoted for off-label uses.

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders. In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only. In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania). In October 2006, the FDA approved Seroquel for bipolar depression.

The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA. Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness). These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.

In March 2006, AstraZeneca brought certain conduct to the attention of the government and then cooperated in the investigation of the allegations being settled today.

The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved
uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

"Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars
directly out of taxpayers' pockets," said Attorney General Eric Holder. "This Administration is committed to recovering taxpayer money lost to health care fraud, whether it's by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation's biggest companies."

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by
AstraZeneca and its agents about the unapproved uses of Seroquel. AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing
messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel. The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for
unapproved uses in violation of the federal Anti-Kickback Statute.

"Rooting out health care fraud is a top priority for the Obama Administration, said Kathleen Sebelius, Secretary of the Department of Health and Human Services. "Today's settlement sends a clear warning to any individual or company seeking to defraud our health care system and returns hundreds of millions of dollars of taxpayer money to the Medicare trust fund where they belong. It reflects the unprecedented energy, resources, and new ideas that this administration has devoted to
identifying, prosecuting, and ultimately preventing health care fraud. With the new anti-healthcare fraud resources in the Affordable Care Act, there has never been a worse time to try to steal from our health care system."

"Consumers are entitled to rely on the claims pharmaceutical companies make about the drugs they sell," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Working with our federal and state partners, we will protect the integrity of our public health programs by ensuring that kickbacks from drug companies do not taint the medical decisions of health care professionals."

"When pharmaceutical companies interfere with the FDA's mission to insure that drugs are safe and effective, they undermine the doctor-patient relationship and put the health and safety of patients at
risk," said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "People have a legal right to know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In addition to the civil settlement agreement, resolution of the matter includes a Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board
of directors committee annually review the company's compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

"As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed -- all leading to better protection for patients," said Department of Health and Human Services Inspector General Daniel R. Levinson.

The government's investigation was triggered by a whistleblower lawsuit filed under the FCA's qui tam provisions in the Eastern District of Pennsylvania. As part of today's resolution, James Wetta, the
whistleblower in that action, will receive more than $45 million from the federal share of the civil recovery.

This settlement is part of the government's emphasis on combating health care fraud and another step for the HEAT initiative, which was announced by Attorney General Holder and Secretary Sebelius in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid fraud through enhanced cooperation. One of the most powerful tools in that effort is the FCA, which the Justice Department has used to recover almost $2.8 billion since January
2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in FCA cases since January 2009 are over $3.75 billion.

The civil settlement was reached by the U.S. Attorney's Office for the Eastern District of Pennsylvania and the Commercial Litigation Branch of the Justice Department's Civil Division. This investigation was conducted by the Department of Health and Human Services Office of Inspector General, U.S. Postal Service's Office of Inspector General and the FDA's Office of Criminal Investigations. Assistance was provided by representatives of FDA's Office of Chief Counsel and the National
Association of Medicaid Fraud Control Units.

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New CDC Study Shows Tobacco Marketing Influences Kids to Smoke, Underscores Need for FDA Regulation of Tobacco Products

/PRNewswire-USNewswire/ -- The following is a statement by Matthew L. Myers, President, Campaign for Tobacco-Free Kids:

Several scientific studies released today provide powerful new evidence that tobacco marketing causes kids to smoke, while anti-tobacco advertising campaigns prevent smoking. These studies send a loud and clear message to the nation's policy makers: We need less tobacco marketing and more tobacco prevention.

It is critical that Congress this year pass legislation granting the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products and marketing, which among other things would crack down on tobacco marketing that appeals to kids. It is also imperative that Congress and the states increase funding for programs proven to prevent kids from smoking and help smokers quit.

CDC Study: Youth Smokers Overwhelmingly Prefer Three Most Heavily Advertised Brands

A study published by the Centers for Disease Control and Prevention (CDC) finds that the three most heavily advertised cigarette brands - Philip Morris' Marlboro, Lorillard's Newport and R.J. Reynolds' Camel - continue to be the preferred brands of youth smokers. These brands were preferred by 78.2 percent of middle school smokers and 86.5 percent of high school smokers. Marlboro is preferred by more high school smokers, 52.3 percent, than all other brands combined.

This study indicates that, despite limited restrictions placed on tobacco marketing by the 1998 state tobacco settlement, tobacco marketing continues to have a large and disproportionate impact on the nation's youth. While tobacco companies claim they do not market to kids, they're sure doing a good job of getting kids to use their products. This study was published in the February 13, 2009, issue of the CDC journal Morbidity and Mortality Weekly Report (www.cdc.gov/mmwr).

Congress can protect our nation's children by granting the FDA authority to regulate the manufacturing, marketing and sale of tobacco products. This bill would impose specific restrictions on tobacco marketing that appeals to children. It would limit tobacco advertising in stores and in magazines with significant teen readership to black-and-white text only, eliminating the colorful images that depict smoking as cool and glamorous. It would ban outdoor tobacco advertising near schools and playgrounds, end tobacco sponsorships of sports and entertainment events, and require stores to place tobacco products behind the counter. The bill would also grant the FDA and the states authority to further limit tobacco marketing.

In addition to these marketing restrictions, the legislation would require larger and more effective health warnings, ban misleading terms such as "light" and "low-tar," strictly regulate all health claims about tobacco products, require disclosure of the contents of and changes to tobacco products, and empower the FDA to mandate changes in tobacco products, such as the reduction or removal of harmful ingredients.

Three Studies Finds truth(R) Prevention Campaign Reduces Smoking and Saves Money

In addition to the new CDC studies, three new research papers find that truth(R), the national youth smoking prevention campaign conducted by the American Legacy Foundation, has been both highly effective and cost-effective in preventing America's youth from starting to smoke. One study found that truth(R) was directly responsible for keeping 450,000 teens from starting to smoke during its first four years, while a second study found that the campaign not only paid for itself in its first two years, but also saved between $1.9 billion and $5.4 billion in health care costs. These two studies were published online today by the American Journal of Prevention Medicine (www.ajpm-online.net). A third study in the February issue of Ethnicity and Health found that youth exposed to the truth(R) campaign were more likely to have anti-tobacco beliefs and attitudes.

These studies show that tobacco prevention campaigns are a vital element of the overall effort to reduce tobacco use and its devastating consequences. Unfortunately, both nationally and in the states, these programs are badly underfunded and fall woefully short of the $13.4 billion a year the tobacco companies spend to market their deadly and addictive products. This year, the states will collect $24.6 billion in revenue from the tobacco settlement and tobacco taxes, but will spend less than three percent of it on tobacco prevention and cessation programs. No state currently meets the CDC's recommendation for funding such programs and many states are considering cuts to their programs.

It is critical that both the federal government and the states increase funding for programs to prevent kids from smoking and help smokers quit. As underscored by the new studies, the evidence is abundantly clear that these programs not only reduce smoking and save lives, they save money by reducing tobacco-related health care costs. It is penny-wise and pound-foolish to skimp on funding for these programs.

Today's new studies follow a landmark August 2008 report by the National Cancer Institute that reached the federal government's strongest conclusions to date that 1) tobacco advertising and promotion cause kids to smoke and 2) mass media campaigns are effective at reducing smoking, especially when combined with other tobacco control strategies.

Tobacco use is the number one cause of preventable death in the United States, killing more than 400,000 people and costing the nation nearly $100 billion in health care bills year. The Institute of Medicine, the President's Cancer Plan and other public health authorities have recommended a clear plan for winning the fight against tobacco use. It includes FDA regulation of tobacco products, well-funded tobacco prevention and cessation programs, and other proven measures such as higher tobacco taxes and smoke-free workplace laws. It is critical that Congress and other elected leaders take urgent action to protect our children and the nation's health.

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