The owner and sole operator of an environmental laboratory was found guilty yesterday in U.S. District Court for the Southern District of Mississippi of all counts of a federal indictment charging falsification of records and obstructing a federal criminal investigation.

Steven Patrick Garcia, Jr., 36, of San Jose, Calif., was sentenced today in federal court in Billings, Mont., to 24 months in prison to be followed by one year of supervised release for selling and offering to sell migratory bird parts in violation of the Migratory Bird Treaty Act (MBTA) and the Lacey Act, the Department of Justice announced today. Garcia had pleaded guilty to the charge on January 16, 2013.

If this sounds like a tall order – or a tough assignment – that’s because it is. But the truth is that, throughout history, this country has always relied on the energy, the optimism, and the fresh ideas of our youngest citizens to drive positive change – and ensure our continued progress.

The Justice Department today announced that a scientist and his wife, who both previously worked as contractors at the Los Alamos National Laboratory (LANL) in New Mexico, have pleaded guilty to charges under the Atomic Energy Act and other charges relating to their communication of classified nuclear weapons data to a person they believed to be a Venezuelan government official.

A former FBI agent and two others have been charged in the Southern District of New York with engaging in a bribery scheme to secure confidential, internal law enforcement documents about a prominent individual in Bangladesh.

The owner of South Louisiana Home Health Care Inc. and the director of nursing for the Louisiana home health agency were sentenced today for their roles in a Medicare fraud scheme involving the payment of kickbacks and the falsification of documents.

The Justice Department and Internal Revenue Service (IRS) announced that Gloria Donoghue was sentenced today in federal court in the Eastern District of New York to18 months in prison for using the mail in her tax refund scheme.

Tennie White, the owner and operator of an environmental laboratory located in Jackson, Miss., was sentenced in federal court late yesterday to 40 months in prison in connection with her conviction for faking laboratory testing results and lying to federal investigators, announced Gregory K. Davis, U.S. Attorney for the Southern District of Mississippi, and Robert G. Dreher, Acting Assistant Attorney General for the Justice Department’s Environment and Natural Resources Division.

A former mayor of South Pittsburg, Tenn., and a co-conspirator pleaded guilty today in Chattanooga, Tenn., to conducting an illegal gambling business, announced Acting Assistant Attorney General Mythili Raman of the Justice Department’s Criminal Division and Special Agent in Charge Kenneth Moore of the FBI’s Knoxville, Tenn., Field Office.

Kan-Di-Ki LLC, formerly known as Kan-Di-Ki Inc., doing business as Diagnostic Laboratories and Radiology (Diagnostic Labs), will pay $17.5 million to settle allegations that the California-based company violated the federal and California False Claims Acts by paying kickbacks for referral of mobile lab and radiology services subsequently billed to Medicare and Medi-Cal (the state of California’s Medicaid program), the Justice Department announced today.

The Justice Department announced today that it intends to file a lawsuit against the State of North Carolina, the North Carolina State Board of Elections, and the Executive Director for the State Board of Elections over recent voting changes made by North Carolina House Bill 589, which was signed into law in August 2013. The United States’ complaint challenges provisions of House Bill 589 under the non-discrimination requirements of Section 2 of the Voting Rights Act.

A federal jury in Detroit today convicted the owner and the program coordinator of two Flint, Mich., adult day care centers for their participation in a $3.2 million Medicare fraud scheme.

The administrator and employee of two Miami health care companies was sentenced today to serve 60 months in prison for her participation in a $74 million home health Medicare fraud scheme.

The Ensign Group Inc., a skilled nursing provider based in Mission Viejo, Calif., that operates nursing homes across the western U.S. has agreed to pay $48 million to resolve allegations that it knowingly submitted to Medicare false claims for medically unnecessary rehabilitation therapy services.

The Department of Justice announced today that a federal grand jury in the Middle District of Alabama has returned an indictment against J. Keith McCray, a criminal investigator with the Macon County, Ala., Sheriff’s Office for violating the rights of a man he unlawfully seized and assaulted.

The Civil Rights Division of the U.S. Department of Justice and the U.S. Attorney’s Office for the Eastern District of New York announced today that they have tentatively agreed to a settlement with the Suffolk County Police Department (SCPD) which calls for SCPD to implement new and enhanced policies and procedures to ensure nondiscrimination in the provision of police services to Latino communities in Suffolk County.

Federal agents arrested Bryan D’Antonio and Charles Wayne Farris for operating the Rodis Law Group and America’s Law Group, businesses that allegedly offered bogus loan modification assistance to struggling homeowners; and Attorney Ronald Rodis surrendered to federal agents on for his alleged role in the operation.

Abbott Laboratories has agreed to pay the United States $5.475 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products, the Justice Department announced today.

U.S. Attorney General Eric Holder on Thursday urged Congress to pass the bipartisan Smarter Sentencing Act, introduced by Senators Dick Durbin and Mike Lee.

The Department of Justice has frozen more than $458 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and conspirators.

The Justice Department announced today that it has reached an agreement in principle with the city of New York and intervening plaintiffs to settle an employment discrimination lawsuit involving the New York City Fire Department.

The leader of a piracy group engaged in the illegal distribution of copies of copyrighted Android mobile device applications and a co-conspirator have pleaded guilty for their roles in the scheme that distributed more than one million copies of copyrighted apps.

J. Keith McCray, a criminal investigator with the Macon County, Ala., Sheriff’s Office, pleaded guilty in federal court today to assaulting a handcuffed man at the county jail, resulting in bodily injury to the victim.

Francis E. Chandler III was sentenced to serve 37 months in prison and ordered to pay $3,066,629 in restitution for filing a false claim for tax refund and false retaliatory liens against four federal government officials.

Members of two different piracy groups engaged in the illegal distribution of copies of copyrighted Android mobile device applications have pleaded guilty for their roles in separate schemes, each designed to distribute more than one million copies of copyrighted apps.

Kimberly Banks, Donalene Mosley and Arneshia Austin were sentenced today in Albany, Ga., to serve 192 months, 37 months and 21 months in prison, respectively, for crimes relating to filing fraudulent income tax returns using stolen identities.

The owner of a Louisiana pharmacy pleaded guilty today for directing a $2.2 million Medicare fraud scheme to repackage and redistribute prescription medications. Mona Patrice Carter, 47, pleaded guilty before U.S. District Judge James J. Brady of the Middle District of Louisiana to one count of health care fraud.

The International Competition Network (ICN) adopted new recommended practices for predatory pricing analysis and competition assessment, and approved new work product on international merger enforcement cooperation, confidentiality protections during investigations, leniency policy and digital evidence gathering.

The owner and operator of a Tennessee salvage and demolition company, A&E Salvage Inc., pleaded guilty today in federal court in Greeneville, Tennessee, for conspiring to violate the Clean Air Act.

An owner and operator of community mental health centers in Baton Rouge, Louisiana, as well as a patient recruiter for a related facility in Houston, Texas, were convicted on Wednesday, May 21, 2014, for their roles in a $258 million Medicare fraud scheme.

The Justice Department today announced a multi-national effort to disrupt the Gameover Zeus Botnet – a global network of infected victim computers used by cyber criminals to steal millions of dollars from businesses and consumers – and unsealed criminal charges in Pittsburgh, Pennsylvania, and Omaha, Nebraska, against an administrator of the botnet.

The Justice Department today announced a settlement with the city of San Jacinto, California, that resolves a lawsuit alleging disability discrimination filed in the U.S. District Court for the Central District of California. Under the settlement, San Jacinto has changed its laws to comply with the Fair Housing Act (FHA) and the Americans with Disabilities Act (ADA).

The owner and operator of a Houston area ambulance company was sentenced today to serve 97 months in prison for her role in a $2.4 million Medicare fraud scheme

Eric Omuro, of Mountain View, California, a.k.a “Red,” was arrested today following his indictment by a federal grand jury on charges involving the use of the mail and the Internet to facilitate prostitution, and multiple counts of money laundering

We recognize the Committee’s interest in this matter. We share that interest and are conducting a thorough and complete investigation and analysis of the allegations of targeting by the IRS. While I know you are frustrated by the fact that I cannot at this time disclose any specifics about the investigation, I do pledge to you that when our investigation is completed, we will provide Congress with detailed information about the facts we uncovered and the conclusions we reached in this matter

A Miami resident who owned a home health care company and was the administrator of another home health care company pleaded guilty today for her participation in a $74 million Medicare fraud scheme

The Department of Justice has forfeited more than $480 million in corruption proceeds hidden in bank accounts around the world by former Nigerian dictator Sani Abacha and his co-conspirators

A former Iowa State Senator pleaded guilty today to concealing payments he received from a presidential campaign in exchange for switching his support and services from one candidate to another and to obstructing a subsequent investigation into his conduct.

J. Keith McCray, previously a criminal investigator with the Macon County, Alabama, Sheriff’s Office, was sentenced today by Judge Myron H. Thompson to serve 36 months in prison and two years of supervised release for assaulting a handcuffed man at the county jail, announced the Justice Department and the U.S. Attorney’s Office for the Middle District of Alabama.

A former senior vice president and chief credit officer of TierOne Bank, a publicly traded commercial bank formerly headquartered in Lincoln, Nebraska, pleaded guilty today for his role in a scheme to defraud TierOne’s shareholders and regulators.

U.S. Attorney Peter Smith for the Middle District of Pennsylvania, Special Agent in Charge John Kelleghan for Philadelphia, U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) and Special Agent in Charge Sidney M. Simon of the New York Field Office, Office of Export Enforcement, U.S. Department of Commerce announced that yesterday Harold Rinko, 72, of Hallstead, Pennsylvania, appeared before Senior District Court Judge Edwin M. Kosik in Scranton and pleaded guilty to conspiracy to illegally export laboratory equipment, including items used to detect chemical warfare agents, from the United States to Syria, in violation of federal law

ALEXANDRIA, Va

The U.S. Food and Drug Administration approved a new high-pressure ventilator developed by NASA to treat coronavirus or COVID-19 patients. The space agency is offering the designs for licensing on a royalty-free basis during the time of the pandemic, hoping to increase the availability of life-saving medical devices.

The spread of COVID-19 is placing unprecedented strain on Philadelphia’s hospitals, public health systems, and residents. Although the full effects of the emergency have yet to be realized, newly released data from 2018 and 2019 provides insight on the state of public health in the city before the pandemic.

The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

Posted by Roger Bate My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization. We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation. You can read the op-ed here [...]