A board certified psychiatrist who co-authored numerous medical papers, he oversaw FDA approval, labeling decisions and guidance documents that influenced the fate some of the best-known psychiatric drugs marketed in the US and helped make him one of the more notable figures in the field of psychiatry.
Laughren, who began his FDA career as a clinical reviewer in the former Division of Neuropharmacological Drug Products in 1986, also played a pivotal role several years ago in the agency handling of a pair of long-running controversies over the safety and use of antidepressants and antipyschotics in young children.
At the time, many antipsychotics were not approved for children, although prescribing was widespread, despite the risks of such side effects as weight gain and diabetes. Meanwhile, there was growing public pressure to increase warnings about the risk of suicide in youngsters who were treated with antidepressants.
For these reasons, Laughren was often on the hot seat at FDA advisory committee meetings and at Congressional hearings (this is an example), where he was a lightning rod for critics who complained the agency was failing to protect public health by not moving faster to warn physicians and patients of the inherent risks of the medicines.
After some emotional FDA advisory meetings in 2004 and 2005, for instance, the agency added Black Box warnings to antidepressants. Laughren, however, later caused a stir when he publicly considered repealing the warnings after studies suggested suicide rates among youngsters were rising because too many doctors feared prescribing the pills (back story).
In 2008, an FDA advisory committee chastised the agency for not doing more to discourage antipsychotic prescribing to youngsters for unapproved uses. The scolding took place during what was to have been a routine meeting of pediatric safety of two antipsychotics, but the panel members expressed disappointment with FDA efforts.
Laughren was on hand to defend the FDA, and his own division. He responded by saying there was little the FDA could do and, instead, largely blamed medical societies, which he maintained were in a better position to alert and educate physicians about side effects and the potential risks involved (back story).
"What was he doing during this period when misrepresentations and misconduct was occurring? Labels were being updated to reflect safety concerns that should have been addressed sooner," says Stephen Sheller, an attorney who has filed lawsuits against Johnson & Johnson (JNJ) that claim its Risperdal antipsychotic caused gynecomastia – the abnormal development of large mammary glands in males – and that labels lacked sufficient warnings.
At the same time, Laughren was respected in the pharmaceutical industry for some of his decisions. In 2007, for instance, he disagreed with a three-person team of FDA medical reviewers, who urged that the Zyprexa antipsychotic sold by Eli Lilly (LLY) should be rejected for pediatric use because of inconsistent data from studies in US and Russian teens (back story).
Such moves, however, prompted some FDA critics, such as Alliance for Human Research Protection, to complain that his appearances on consensus treatment panels that sometimes included industry representation and backing smacked of a conflict of interest. The FDA rejected the accusation.
An FDA spokeswoman writes us that one of the last projects in which Laughren was involved was working on a guidance document for prospectively assessing for suicidal ideation and behavior in drug trials. She adds that his retirement had been planned. Laughren could not be reached for comment.