And another kind of “drug deal”
By Phil Mattera for the Dirt Diggers Digest
As the political news is dominated
by discussion of quid pro quo and bribery, there has been another ongoing
series of allegations about improper payments for things of value.
The other quid pro quo relates to the pharmaceutical industry, which has been the subject of a seemingly never-ending scandals about financial inducements given to healthcare professionals.
The other quid pro quo relates to the pharmaceutical industry, which has been the subject of a seemingly never-ending scandals about financial inducements given to healthcare professionals.
The most significant recent case
involves a company called Avanir Pharmaceuticals, which had to pay more than $115 million to resolve
allegations that it paid kickbacks to physicians to get them to prescribe its
drug Nuedexta for uses not approved as safe by the Food and Drug
Administration.
Among those uses were the treatment
of behaviors associated with dementia among residents of long-term care
facilities. Nuedexta was tested and approved for patients exhibiting what is
known as pseudobulbar affect (PBA) — involuntary, sudden, and frequent episodes
of laughing or crying that occur secondary to a neurologic disease or brain
injury.
The case against Avanir included
allegations that physicians receiving its payments ended up putting large
numbers of patients on Nuedexta who showed no symptoms of PBA, exposing them to
unknown risks.
The Justice Department regarded
Avanir’s behavior to be serious enough to warrant criminal charges, but like in
so many other cases, the company was offered a deferred prosecution agreement
that allowed it to buy its way out of full legal jeopardy by paying criminal
penalties of nearly $13 million.
The company agreed to cooperate in the prosecution of several individuals who received the kickbacks and whose liability may end up being more than financial in nature.
The company agreed to cooperate in the prosecution of several individuals who received the kickbacks and whose liability may end up being more than financial in nature.
In addition to the criminal matter,
Avanir agreed to pay $103 million to settle a related civil False Claims Act
case based on the fact that federal and state healthcare programs ended up
paying claims stemming from the improper prescribing of Nuedexta.
Avanir’s alleged behavior is
especially troublesome because of the involvement of elderly dementia patients,
but the use of kickbacks is far from unknown in the pharmaceutical industry.
In Violation Tracker we document about 50 drug industry cases in which kickbacks were the primary or secondary offense.
In Violation Tracker we document about 50 drug industry cases in which kickbacks were the primary or secondary offense.
These cases, which have resulted in
more than $7 billion in fines and settlements, have implicated pretty much
every large pharmaceutical producer and numerous smaller ones as well. Some
companies show up on the list several times.
These include Abbott Laboratories, which along with its subsidiaries has been involved in six cases between 2003 and 2017 that resulted in $630 million in penalties, and Pfizer, which together with its subsidiaries has paid $531 million in five cases between 2004 and 2018.
These include Abbott Laboratories, which along with its subsidiaries has been involved in six cases between 2003 and 2017 that resulted in $630 million in penalties, and Pfizer, which together with its subsidiaries has paid $531 million in five cases between 2004 and 2018.
The extent of the recidivism in drug
industry kickback cases suggests that the industry is not taking the problem
very seriously and that the Justice Department’s approach has not had the necessary
deterrent effect. Perhaps there is a lesson here for the political world as
well.