Drugs

Hi-Tech Pharma CEO Convicted in GMP Fraud Scheme

Hi-Tech Pharmaceuticals CEO and twice-convicted felon Jared Wheat has been found guilty of orchestrating a years-long scheme to forge manufacturing safety certifications and defraud customers out of more than $4.7 million. The Norcross, Ga.–based dietary supplement manufacturer was also convicted on multiple counts, including wire fraud and money laundering, following a six-week federal trial.

Prosecutors said Wheat and Hi-Tech fabricated documents between 2011 and 2013 to make it appear the company had passed independent audits verifying compliance with federally mandated GMP standards. “After two prior federal felony convictions, Wheat yet again put profits over product quality and consumer safety,” U.S. Attorney Theodore S. Hertzberg said in a statement.

According to evidence presented at trial, Hi-Tech hired a legitimate third-party auditing firm in 2010, which identified 75 serious GMP deficiencies — about 40% of the total criteria assessed. Problems included gaps in doors that could allow rodent entry, products exposed to dust before packaging, and major lapses in testing raw materials and finished products.

Rather than address the findings, Wheat and his company forged a certificate claiming GMP compliance, falsely attributing it to a Belize-based firm called PharmaTech Consulting. Prosecutors said PharmaTech was secretly owned by Wheat, had conducted no inspection, and listed one of Wheat’s former attorneys as its “general manager,” complete with a forged signature.

Hi-Tech also altered the legitimate audit report, changing every “Not Acceptable” rating to “Acceptable” and swapping in PharmaTech’s name as the auditor. In addition, the company fabricated and altered FDA Certificates of Free Sale, which customers often used to gain foreign regulatory approval to import Hi-Tech products.

Federal agents said the scheme led customers to unwittingly submit falsified documents to regulators overseas, enabling Hi-Tech to sell products abroad that lacked verified manufacturing safety assurances. Customers paid more than $4.7 million to Hi-Tech during the period prosecutors said the company was distributing fabricated certificates.

“Making fraudulent claims about FDA-regulated products shows a reckless disregard for public health and safety,” said Kelly McCoy, acting special agent in charge of the FDA’s Office of Criminal Investigations.

Wheat now faces up to 20 years in prison on the wire fraud conviction. His criminal history includes a 1991 federal drug trafficking conspiracy conviction and a 2009 conviction for conspiracy involving mail fraud, wire fraud, and distribution of misbranded and unapproved drugs. Hi-Tech Pharmaceuticals faces potential fines of up to twice the amount of illicit proceeds — nearly $10 million — along with up to five years’ probation. Sentencing has not yet been scheduled.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome