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In Earlier post we understood Understanding basic difference between Form 483 in Pharma Industry?
Now in this article we are going to understand Understanding basic difference between Form 483 & Warning Letters.
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What is Whistle-blowing?
The pharmaceutical industry is huge, Worldwide and
more closer to home.
India is also one of the largest exporters of
medicines to the United States. Medicines are highly regulated for expected
reasons.
Over the
last few years, corporate India has seen the rise of a new kind of crusader –
the whistle-blower.
These
champions have tried to uncover many scams related to Violation of laws,
various data integrity issues & fraud activity.
Whistleblowing is a term
that describes people who become aware of activities within an organization or
entity that are legally questionable.
The FDA has believed that whistle blowing among
employees & former employees is a critical way of maintaining compliance
& corporate data integrity.
Whistleblowers Types:
•
Internal whistleblower: The
whistleblower has a connection to the organization. This could be an employee,
an officer, or a shareholder.
•
External whistleblower: External
whistleblowers reveal the activity to someone outside the company. That entity
may be a law enforcement agency that has jurisdiction
Law that protect Whistle-blowers
In the United States the False
Claims Act encourages whistle-blowing by private individuals to expose evidence
of fraud.
They are rewarded for their efforts
with monetary compensation and protection from retaliation.
The FCA also contains an anti-retaliation provision
which protects an employee from being “discharged, demoted, suspended,
threatened, harassed, or in any other manner discriminated against in the terms
& conditions of employment by his or her employer”
A former employee of a global pharma giant, received a
$96-million settlement after suing her former employer under the False Claims
Act (FCA).
Her initial whistle blowing case dealt with various
data integrity issues as well dangerous slip ups such as product mix ups,
missing validations & SOP’s in need of revision.
What was most shocking was that the company did not appeal & this became the first ever pharmaceutical whistle blowing lawsuit to invoke cGMP’s & succeed.
Reason of whistle-blowing
•
Failure to Comply
with cGMPs Misrepresenting the safety & efficacy of drugs to federal
regulators
•
Off-label Marketing: The law prohibits
drug manufacturers from marketing or promoting a drug for a use that the FDA
has not approved.
•
Kickbacks: The law prohibits
drug companies from offering or paying any remuneration, in cash or kind,
directly or indirectly, to induce physicians or others to order or recommend
drugs that may be paid for by a federal healthcare program.
•
Upcoding: Providers may not
prescribe more of a drug than is medically necessary or for uses other than
those approved by the FDA.
•
Ghost-Writing & Seeding Trials companies
draft medical papers promoting off-label uses of drugs & pay doctors to
insert their names as authors of the documents
•
Overcharging federal healthcare programs for drugs
How to avoid whistle-blowing?
To promote a zero tolerance approach
towards malpractice,
Begin at grass roots level with the
behavioral change of staff
Staff should be encouraged to report
irregularities without fear
Staff should be trained in corporate
policy & implementation.
Maintain proper internal control
Set effective communication between
management & staff
Steps to a Successful Whistleblower Claim
Determine Whether A False Claim Exists
Don’t Talk to Anyone Except Your Lawyer
Gather Evidence Legally and
Confidentially
Draft and File Your Whistleblower Claim
Assist with the Investigation
Prepare for Potential Retaliation
Have Check in Hand Before Spending the
Money
Reviewing
the legalities
India
The
Companies Act 2013 has made it mandatory for listed companies or such class of
companies to establish vigil mechanisms for their directors and employees, in
order to report genuine concerns in the recommended manner.
Clause 49
of the SEBI listing agreement also lays down similar provisions. Since drugs
relate to patient safety, a sensitive subject, the CDSCO has devised a reward
scheme for blowing the whistle on spurious or fake drugs.
USA
Under the
Dodd-Frank Wall Street and the False Claims Act, an individual with knowledge
of fraud committed by a business may blow the whistle to defined regulatory
bodies.
If the
claim is proven valid, the whistle-blower is entitled to a percentage, or
“bounty”, of the sum recovered. Additionally, the Department of Justice (DoJ)
has enforced CGMP violations under the False Claims Act.
Case Study
A
bounty-ful reward An employee of a leading company blew the whistle on the
company’s questionable manufacturing practices.
This was corroborated
by providing evidence to the regulatory authorities on the company falsifying
drug data and violating good manufacturing practices.
The
investigation resulted in the drug maker pleading guilty to the wrongdoing and
paying a hefty sum in settlement. The whistle-blower was awarded a significant
sum from the regulator.
Q: Does your organization have a whistle-blowing mechanism to report and investigate quality concerns, if any?
Did you
know?
The CDSCO
has implemented a reward scheme for individuals who report companies
manufacturing fake or spurious drugs.
Association
of Certified Fraud Examiners reports that whistle blowing is the most powerful
method of identifying fraud in organizations.
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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