FDA takes aim at corporate executives to rein in pharma abuses

[Guest guest]

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-takes-aim-at-corporate-executives-to-reign-in-/ArticleStandard/Article/detail/713115?contextCategoryId=40159

FDA takes aim at corporate executives to rein in pharma abuses

Publish date: Mar 29, 2011

By: From

staff reports

FDA has a new target in its continuing efforts to clean up

pharmaceutical industry abuses: individual corporate officials.

The most recent targets are the vice president of quality and the

vice president of operations for OTC Products at McNeil Consumer

Healthcare, a subsidiary of & . The two are

named as defendants in a consent decree of permanent injunction

for failing to comply with current good manufacturing practice

requirements at plants in Pennsylvania and Puerto Rico that

resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry

insiders. FDA warned last November that it was resurrecting a

1970s legal doctrine to bring criminal charges against top

executives. The goal, said Blumberg, FDA deputy chief counsel

for litigation, was to “change the corporate culture” at firms

that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a

Food and Drug Law Institute meeting in Philadelphia. “We need to

put something else on the scale to make people think twice, three

times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid

$1.4 billion in 2009 for crossing the line in marketing Zyprexa

(olanzapine) and Pfizer paid $2.3 billion for illegal marketing of

Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case

against Acme Markets President Park. FDA charged Park

personally with sanitation violations following multiple warning

notices. The U.S. Supreme Court agreed that Park, as company

president, was ultimately responsible for ensuring compliance.

In 2007, 3 executives of Purdue Frederick Company pled guilty to

charges of misbranding OxyContin (oxycodone). The trio paid $634.5

million to the Virginia Medicaid Fraud Unit and were barred from

federal healthcare programs for 12 years.

In 2010, 4 executives of Synthes pled guilty for off-label

promotion of a bone cement. The 4 face fines of up to $10,000 each

and a year in federal prison.

Other recent targets include former GlaxoKline Vice

President s, indicted for making false statements and

obstructing an FDA investigation into illegal marketing of

Wellbutrin SR (bupropion sustained release) and former KV

Pharmaceutical CEO and Chairman of the Board Marc Hamerlin, barred

from participating in federal healthcare programs for 20 years.

“This is the topic of a lot of discussions and concerns among

executives across the pharmaceutical industry,” said Victor

Kleinman, executive vice president, Global Life Sciences, for the

executive search firm DHR International. “There are companies

where these kinds of issues keep the CEO up at night.”

[Guest guest]

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-takes-aim-at-corporate-executives-to-reign-in-/ArticleStandard/Article/detail/713115?contextCategoryId=40159

FDA takes aim at corporate executives to rein in pharma abuses

Publish date: Mar 29, 2011

By: From

staff reports

FDA has a new target in its continuing efforts to clean up

pharmaceutical industry abuses: individual corporate officials.

The most recent targets are the vice president of quality and the

vice president of operations for OTC Products at McNeil Consumer

Healthcare, a subsidiary of & . The two are

named as defendants in a consent decree of permanent injunction

for failing to comply with current good manufacturing practice

requirements at plants in Pennsylvania and Puerto Rico that

resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry

insiders. FDA warned last November that it was resurrecting a

1970s legal doctrine to bring criminal charges against top

executives. The goal, said Blumberg, FDA deputy chief counsel

for litigation, was to “change the corporate culture” at firms

that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a

Food and Drug Law Institute meeting in Philadelphia. “We need to

put something else on the scale to make people think twice, three

times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid

$1.4 billion in 2009 for crossing the line in marketing Zyprexa

(olanzapine) and Pfizer paid $2.3 billion for illegal marketing of

Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case

against Acme Markets President Park. FDA charged Park

personally with sanitation violations following multiple warning

notices. The U.S. Supreme Court agreed that Park, as company

president, was ultimately responsible for ensuring compliance.

In 2007, 3 executives of Purdue Frederick Company pled guilty to

charges of misbranding OxyContin (oxycodone). The trio paid $634.5

million to the Virginia Medicaid Fraud Unit and were barred from

federal healthcare programs for 12 years.

In 2010, 4 executives of Synthes pled guilty for off-label

promotion of a bone cement. The 4 face fines of up to $10,000 each

and a year in federal prison.

Other recent targets include former GlaxoKline Vice

President s, indicted for making false statements and

obstructing an FDA investigation into illegal marketing of

Wellbutrin SR (bupropion sustained release) and former KV

Pharmaceutical CEO and Chairman of the Board Marc Hamerlin, barred

from participating in federal healthcare programs for 20 years.

“This is the topic of a lot of discussions and concerns among

executives across the pharmaceutical industry,” said Victor

Kleinman, executive vice president, Global Life Sciences, for the

executive search firm DHR International. “There are companies

where these kinds of issues keep the CEO up at night.”

[Guest guest]

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-takes-aim-at-corporate-executives-to-reign-in-/ArticleStandard/Article/detail/713115?contextCategoryId=40159

FDA takes aim at corporate executives to rein in pharma abuses

Publish date: Mar 29, 2011

By: From

staff reports

FDA has a new target in its continuing efforts to clean up

pharmaceutical industry abuses: individual corporate officials.

The most recent targets are the vice president of quality and the

vice president of operations for OTC Products at McNeil Consumer

Healthcare, a subsidiary of & . The two are

named as defendants in a consent decree of permanent injunction

for failing to comply with current good manufacturing practice

requirements at plants in Pennsylvania and Puerto Rico that

resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry

insiders. FDA warned last November that it was resurrecting a

1970s legal doctrine to bring criminal charges against top

executives. The goal, said Blumberg, FDA deputy chief counsel

for litigation, was to “change the corporate culture” at firms

that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a

Food and Drug Law Institute meeting in Philadelphia. “We need to

put something else on the scale to make people think twice, three

times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid

$1.4 billion in 2009 for crossing the line in marketing Zyprexa

(olanzapine) and Pfizer paid $2.3 billion for illegal marketing of

Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case

against Acme Markets President Park. FDA charged Park

personally with sanitation violations following multiple warning

notices. The U.S. Supreme Court agreed that Park, as company

president, was ultimately responsible for ensuring compliance.

In 2007, 3 executives of Purdue Frederick Company pled guilty to

charges of misbranding OxyContin (oxycodone). The trio paid $634.5

million to the Virginia Medicaid Fraud Unit and were barred from

federal healthcare programs for 12 years.

In 2010, 4 executives of Synthes pled guilty for off-label

promotion of a bone cement. The 4 face fines of up to $10,000 each

and a year in federal prison.

Other recent targets include former GlaxoKline Vice

President s, indicted for making false statements and

obstructing an FDA investigation into illegal marketing of

Wellbutrin SR (bupropion sustained release) and former KV

Pharmaceutical CEO and Chairman of the Board Marc Hamerlin, barred

from participating in federal healthcare programs for 20 years.

“This is the topic of a lot of discussions and concerns among

executives across the pharmaceutical industry,” said Victor

Kleinman, executive vice president, Global Life Sciences, for the

executive search firm DHR International. “There are companies

where these kinds of issues keep the CEO up at night.”

[Guest guest]

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-takes-aim-at-corporate-executives-to-reign-in-/ArticleStandard/Article/detail/713115?contextCategoryId=40159

FDA takes aim at corporate executives to rein in pharma abuses

Publish date: Mar 29, 2011

By: From

staff reports

FDA has a new target in its continuing efforts to clean up

pharmaceutical industry abuses: individual corporate officials.

The most recent targets are the vice president of quality and the

vice president of operations for OTC Products at McNeil Consumer

Healthcare, a subsidiary of & . The two are

named as defendants in a consent decree of permanent injunction

for failing to comply with current good manufacturing practice

requirements at plants in Pennsylvania and Puerto Rico that

resulted in massive product recalls.

The tactic of going after individuals is no surprise to industry

insiders. FDA warned last November that it was resurrecting a

1970s legal doctrine to bring criminal charges against top

executives. The goal, said Blumberg, FDA deputy chief counsel

for litigation, was to “change the corporate culture” at firms

that have shrugged at billion dollar penalties.

“It is clear that fines are not working here,” Blumberg told a

Food and Drug Law Institute meeting in Philadelphia. “We need to

put something else on the scale to make people think twice, three

times.”

Blumberg was talking about illegal drug marketing. Eli Lilly paid

$1.4 billion in 2009 for crossing the line in marketing Zyprexa

(olanzapine) and Pfizer paid $2.3 billion for illegal marketing of

Bextra (valdecoxib).

FDA’s weapon of choice is the Park Doctrine, based on a 1975 case

against Acme Markets President Park. FDA charged Park

personally with sanitation violations following multiple warning

notices. The U.S. Supreme Court agreed that Park, as company

president, was ultimately responsible for ensuring compliance.

In 2007, 3 executives of Purdue Frederick Company pled guilty to

charges of misbranding OxyContin (oxycodone). The trio paid $634.5

million to the Virginia Medicaid Fraud Unit and were barred from

federal healthcare programs for 12 years.

In 2010, 4 executives of Synthes pled guilty for off-label

promotion of a bone cement. The 4 face fines of up to $10,000 each

and a year in federal prison.

Other recent targets include former GlaxoKline Vice

President s, indicted for making false statements and

obstructing an FDA investigation into illegal marketing of

Wellbutrin SR (bupropion sustained release) and former KV

Pharmaceutical CEO and Chairman of the Board Marc Hamerlin, barred

from participating in federal healthcare programs for 20 years.

“This is the topic of a lot of discussions and concerns among

executives across the pharmaceutical industry,” said Victor

Kleinman, executive vice president, Global Life Sciences, for the

executive search firm DHR International. “There are companies

where these kinds of issues keep the CEO up at night.”