Pharma 101 - Pharmaceutical Fraud » fraud

FDA’s Postmarketing Studies and Clinical Trials Draft Guidance Gets Supported By Public Citizen

Nolan and Auerbach — Mon, 02 Nov 2009 22:07:32 +0000

In an October 13 letter to the FDA, the well respected consumer advocacy organization Public Citizen, gave a strong endorsement to the FDA Draft Guidance on Postmarketing Studies and Clinical Trials. In letter, Public Citizen’s Deputy Director Peter Lurie MD, MPH, and Sidney M. Wolfe, MD, wrote: “Public Citizen has reviewed the draft guidance in detail and supports its purpose and approach. The guidance makes a sensible distinction between studies that are for efficacy purposes only (“postmarketing commitments….”) and those that have any significant safety element (“postmarketing requirements….”). The categories of studies that can fall under postmarketing requirements (observational studies, clinical trials, animal studies, in vitro studies, pharmacokinetic studies, and interaction/bioavailability studies) are appropriately broad. We urge you to resist any efforts to weaken the draft guidance.” (Emphasis supplied)

To review the draft guidance, go to: http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809f1ed1.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Biotech Company and Its Top Management Indicted for Illegal Promotion, Making False Statements to the FDA

Nolan and Auerbach — Sat, 31 Oct 2009 00:00:02 +0000

The Federal Bureau of Investigation (FBI) Boston announced October 28, 2009, that Stryker Biotech and its top management had been indicted for illegal promotion of medical devices used in surgery. The Hopkinton, Mass.-based biotech and some of its employees were charged in federal court with participating in a fraudulent marketing scheme of medical devices used during invasive spinal and long bone surgeries, as well as with making false statements to the United States Food and Drug Administration (FDA).

According to the FBI’s press release, the allegations are that all the defendants participated in an illegal, off-label marketing scheme to promote medical devices used during invasive surgeries. In particular, the defendants are alleged to have promoted devices used to stimulate bone growth in long bones and the spine, which have highly restrictive FDA approval, for off-label, more widespread uses.

For the full press release, go to: http://boston.fbi.gov/dojpressrel/pressrel09/bs102809.htm.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Pharma Co. to pay more than $24 million for kickback, conspiracy charges

Nolan and Auerbach — Wed, 16 Sep 2009 01:06:30 +0000

Biovail Pharmaceuticals, LLC, has pled guilty to conspiracy and kickback charges and has been sentenced to pay a criminal fine of more than $22 million. These charges concern various actions by the New Jersey-based pharmaceutical company and its employees to carry out a program in which Biovaile paid or cause to be paid up to $1,000 to thousands of physicians and others in order to induce them to prescribe or recommend the drug Cardizem, L.A.

BioVail Pharmaceuticals will also pay more than $2.4 million to the United States to resolve allegations that this conduct caused false claims to be submitted to the United States, according to a September 14, 2009 press release by the Massachusetts Department of Justice.

For the full press release, go to: http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Sept2009/BiovailPlea.html.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA .

Small Case Nets Government $3.9 Million for Alleged Medicaid Fraud

Nolan and Auerbach — Sat, 15 Aug 2009 03:30:30 +0000

Special Design Healthcare, a Cape Girardeau, Mo.-based pharmacy, has settled with the U.S. and states of Missouri and Illinois to pay $3.9 million for allegations of Medicaid fraud. According to an article in the August 13, 2009 Chicago Tribune, the pharmacy’s owner is charged with submitting false and fraudulent claims to the two states’ Medicaid programs.

Between October 2002 to June 2006, prosecutors “allege the pharmacy billed Missouri and Illinois Medicaid for more drugs than it purchased, charged for brand name medicine when it dispensed generic, and billed without proper medical authorization,” according to the Chicago Tribune article.

For the full article, go to: http://www.chicagotribune.com/news/chi-ap-mo-medicaidfraud,0,6683688.story.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Grassley Probes into Ghostwriting Practices that May Result in Pharmaceutical Fraud

Nolan and Auerbach — Sat, 11 Jul 2009 14:39:51 +0000

United States Senator Charles E. Grassley of Iowa has asked eight leading medical journals to describe their ghostwriting policies and practices. The inquiry is part of his broader effort to establish transparency with regard to financial relationships between the pharmaceutical industry and medical professionals, according to a July 2, 2009 press release by the senator. Such financial relationships can lead to pharmaceutical fraud practices, such as off-label marketing.

In December, Grassley wrote to Wyeth and DesignWrite, a medical education and communications company, regarding allegations that Wyeth hired DesignWrite to draft articles promoting the company’s hormone therapy products and seek academic investigators to sign on as the primary authors. Previously, Grassley had written to Merck and Scientific Therapeutics Information, a medical publishing company, regarding similar allegations reported in the Journal of the American Medical Association related to articles on Merck’s VIOXX studies.

He sent the letter on July 1 to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, The Journal of the American Medical Association and The New England Journal of Medicine. Grassley asked for the editors’ written responses by July 22, 2009.

For the full press release, go to: http://finance.senate.gov/press/Gpress/2009/prg070209.pdf.

For more information about qui tam law and health care fraud, contact Nolan and Auerbach, PA.

Progress and Deficiencies in the Registration of Clinical Trials

Nolan and Auerbach — Sat, 14 Feb 2009 20:00:42 +0000

The New England Journal of Medicine just recently published an article which raises questions about the ethics and the science of increasingly conducting studies, or clinical trials, outside the United States — when the studies are meant to gather evidence for new drugs to gain approval in this country. The concept certainly raised the issue of whether there is increased clinical trial fraud outside of this country, to the extent there is less oversight and/or ethics. See Ethical and Scientific Implications of the Globalization of Clinical Research, February 19, 2009.

To read more click on
http://content.nejm.org/cgi/content/full/360/8/824

Federal Judge Rules Drug Companies Engaged in Drug Price Deception

Nolan and Auerbach — Mon, 25 Jun 2007 14:32:27 +0000

In a class action lawsuit that claims drug companies unfairly adjusted prices of medication, the plaintiffs scored a major victory when Judge Saris found that defendants “unfairly and deceptively caused false AWPs to be published knowing that payers and the government did not understand the truth and the severity of the markups.” The named defendants are AstraZeneca, Schering-Plough and Bristol-Myers Squib.

In her opinion dated June 21, 2007, Judge Saris wrote that “Unscrupulously taking advantage of the flawed AWP system … by establishing secret mega-spreads far beyond the standard industry markup was unethical and oppressive.” She also wrote that such practices, “caused real injuries to the insurers and patients” who paid inflated prices for life-sustaining drugs. Such drug pricing fraud is part of a broad category of pharmaceutical fraud.

AWP is Average Wholesale Price, the measure by which drugs were generally paid for by healthcare payors in years past. Medicare now pays for drugs on an Average Sales Price basis, which is an actual price and less likely to be manipulated.

To read more of the story look here.

Clinical investigator indicted for fraud in pharmaceutical trials of blockbuster drug

Nolan and Auerbach — Fri, 15 Jun 2007 14:51:06 +0000

NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday.

One area of charges involves clinical trial fraud. According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug’s safety and effectiveness in children and adolescents.

During approximately a five-year period, Palazzo also defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary , according to the indictment.

The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive. (Consulting and Medical director costs of hospitals are passed on to Medicare in part, under the cost report system).

See the full story here.

Aventis Aware of Fraudulent Data Regarding Ketek Says CRO Employee

Nolan and Auerbach — Thu, 22 Feb 2007 17:43:13 +0000

A former staff member of the Pharmaceutical Product Development (PPD) has claimed that Aventis and PPD – the contract research organization (CRO) hired by Aventis- both knew of fraudulent data in a postmarketing trial for the antibiotic drug during a testimony before a US Congressional subcommittee last week.

The postmarketing study was carried out between November 2001 and March 2002 on behalf of Aventis by PPD, after the FDA required more safety information on Ketek following concerns that it could cause liver problems.

The study was allegedly riddled with fraud, including unscrupulous patient recruitment by some of the enrolling doctors and significant under reporting of adverse events.

To read more about CRO fraud and how it can result in a violation of the False Claims Act, click here.

Is Big Pharma Manufacturer Roxane Overcharging the Government?

Nolan and Auerbach — Tue, 06 Feb 2007 15:23:11 +0000

The United States Attorney’s Office announced on January 29, 2007, in Boston, Massachusetts that it is intervening in a whistleblower lawsuit filed against Boehringer Ingelheim Roxane, Inc. (”Roxane”) The allegations center around the contention that Roxane reported inflated prices for numerous pharmaceutical products knowing the federal health care programs would establish reimbursement rates based on these fraudulent prices. According to the Government’s complaint, these reported prices were in excess of 1,000 percent of the actual sales prices on several of the drugs it manufactures. It is alleged that damages to federal programs exceeds $500 million.

To read more about pharmaceutical fraud, click here.