Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. 
 

Dallas News had another article about the lack of supervision, enforcement, and investigation of nursing home complaints of neglect and abuse in Texas.  Regulators have repeatedly found problems and cited violations at Veterans Land Board, which the General Land Office is the parent agency of the veterans board.   But the criminal investigation into Bryson Vanderbilt, 25, and Connie Mae Johnson, 52, charged with "striking, pushing, grabbing and forcefully handling" two residents in separate incidents languished for over two years because of confusion over who should investigate, cumbersome bureaucracy and conflicts among local police, state officials and home administrators,

The witnessed allegation of abuse includes a CNA grabbing a 97-year-old from his wheelchair and slam him into his bed. Another employee at the home was accused of punching and trying to choke Albert Teague, 84, a Marine who fought at Iwo Jima. Felony charges were finally filed against the ex-employees last month.   The allegations that resulted in the recent criminal charges were first checked by Big Spring police in late 2007. But interviews and records obtained by The News through state open-records laws indicate that a criminal investigation was delayed partly because the police yielded to the state agency that inspects nursing homes.

Senior Dimensions, the Austin-based firm that manages the home under a state contract, said it contacted the police and began an internal investigation. The police report, dated Nov. 9, 2007, said Cpl. Adam Stovall spoke with a unit manager who said a certified nurse aide had seen a male co-worker abusing one of the residents.

But, Stovall wrote, the home’s administrator, Bob Kerr, would not give police copies of the employee statements about the incidents.

Stovall said he saw one statement, from resident Wilson Sikes, who said he had slammed Vanderbilt’s hand in his nightstand because the man was going through his belongings. Vanderbilt then "lifted his wheelchair and dumped Sikes in his bed, then sat on him and slapped him across the face with gloves," the police report said.

Sikes recounted the same abuse to Stovall, who said he saw no "obvious injuries" to Sikes.

Kerr, a Senior Dimensions employee, told The News that he couldn’t recall whether he declined to turn over witness statements. But if so, he said, it was "because we were in the process of doing an internal investigation and we felt those were part of our internal investigation."

Senior Dimensions said last week that it wouldn’t release a copy of its internal investigation.

 

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