As all new investigational drugs and biologics must undergo clinical trials on human subjects to demonstrate safety and efficacy prior to approval for sale in the United States, pharmaceutical manufacturers sponsor trials involving investigators and patients both inside and outside the United States. The data in support of  a particular product’s approval therefore comes from both U.S. and foreign clinical trials. The FDA, as mandated by the Food, Drug and Cosmetic Act is charged with the responsibility of ensuring the rights, safety and well-being of subjects who participate in these trials and of verifying that the clinical trial data collected are both accurate and reliable.

In the Report, the FDA found that 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials. Further, over half of clinical trial subjects and sites were located outside the United States.  Astonishingly, the FDA inspected clinical investigators at less then 1 percent of foreign sites!

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

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to healthcare providers to induce them to prescribe these, as well as other, drugs.

Additional whistleblower lawsuits filed under the qui tam provisions of the False Claims Act are pending, according to a September 2 press release by the United States Department of Justice.

For the full press release, go to: http://www.usdoj.gov/opa/pr/2009/September/09-aag-900.html.

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

While Mylan has not publically acknowledged serious problems at its generic drug manufacturing facility, the Pittsburgh Post-Gazette has obtained internal reports alleging that employees at the Morgantown, W. Va. plant have violated government-mandated quality control procedures. According to the Post-Gazette, “… workers were routinely overriding computer-generated warnings about potential problems with medications… .”

Current Good Manufacturing Violations may render pharmaceuticals to be adulterated and may also be the basis of False Claims Act violations. In particular, falsification in CGMP record-keeping may be false records or statements that cause false claims for such adulterated pharmaceuticals to be submitted to Government payors.

Mylan is the world’s third largest generic drug company and the plant in Morgantown produces about 19 billion doses of medicine each year to treat diabetes, hypertension, depression, cancer, epilepsy and other conditions, according to the article.

It is unclear whether the multiple and serious FDA violations in the report resulted in tainted medications.

For the full article, go to: http://www.post-gazette.com/pg/09207/986516-28.stm.

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

on the  $1.1billion included in the recovery Act for comparative effectiveness research.  The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given condition.

Not only will these  findings enhance medical decision-making by patients and their physicians,  they will likely  close the door a little bit more to the success of off-label marketing of pharmaceuticals for indications that have little to no science to back up the claims of efficacy. Physicians will hopefully have a readily available source from which to compare treatments and drugs.

In the letter, addressed to Frank M. Torti, MD, MPH, Grassley writes: “While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.”

Grassley’s concern is that FDA employees should have the right to talk to Congress and to provide Congress with information free and clear of FDA agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal, he writes.

For the letter in its entirety, go to http://www.iowapolitics.com/index.iml?Article=153174. For more information about qui tam law and health care fraud, including pharmaceutical fraud, contact Nolan and Auerbach, PA.

The Department of Justice has filed a civil complaint against Forest Laboratories alleging that the pharmaceutical company intentionally concealed a clinical study containing negative results involving the drugs Celexa and Lexapro.  According to the complaint, several top executives at the company did not disclose the results of the study that showed that the drugs were not effective and could even pose risks to children.  In spite of this information, from 2001-2004 the company promoted clinical trials showing the effectiveness of the drugs while concealing the existence of the negative study to anyone including its own medical advisors or sales reps.  Further, the complaint alleges that Forest Laboratories paid pharmaceutical kickbacks including paying for vacations and other benefits to physicians to promote the drugs’ use by physicians.

Celexa and Lexapro are popular antidepressants approved by the FDA only for adults.  They are two versions of the same drug, Citalopram. Lexapro is Forest Labs’ blockbuster drug with sales of $2.8 billion in 2008.The company however actively improperly marketed these drugs for children even though in 2008 they sought approval from the FDA to use the drug to treat depression in adolescents.  While antidepressants approved for adults are used by physicians to treat children, Celexa and Lexapro now carry a prominent “black box” warning that these drugs could cause suicidal thinking or behavior in some children.

It appears that the Government has joined a whistleblower lawsuit filed by two former Forest Labs employees.  This follows what has clearly been a long-running federal investigation triggered by the filing of a qui tam lawsuit.

To read more click on http://www.nytimes.com/2009/02/26/business/26drug.html?emc=eta1

or if you think that you have a Medicare Fraud case click on http://www.whistleblowerfirm.com/medicare-fraud/

To read the complete article; to read more about pharmaceutical fraud.

To read more click here. To learn more about drug company inducements as a violation of the False Claims Act, click here.

The FDA lacks an effective system for monitoring postmarketing study commitments.  See the latest OIG Report, dated June 2006.