FDA Issues Draft Guidance For Investigator Conflicts

In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.

In shift, feds target top execs for health fraud

Federal investigators say they are starting to target individual executives in health care fraud cases previously aimed at impersonal corporations.

It’s raising the stakes for corporate honchos at drug companies, medical device manufacturers, nursing home chains and others who deal with Medicare and Medicaid.

Grassley Investigates Drugging of Elderly with Antipsychotics

Sen. Charles Grassley recently sent a letter to the administrator of the U.S. Centers for Medicare and Medicaid Services. He wants some answers after a federal report Grassley requested found many nursing home residents with dementia are given antipsychotic drugs. These drugs are not approved to treat dementia. They can be lethal for those afflicted with it, and Medicare has been paying for them.

Cause for alarm: Antipsychotic drugs for nursing home patients

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.