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FDA’s Enforcement Actions
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FDA has
authority to take both administrative and judicial actions to protect
the public from dangerous and illegal products, to punish persons and companies
who violate the law, and to deter violations.FDA can take following enforcement
actions in case of GMP violations / non compliance.
1.Influence
on product approval:
Temporary
Denial of Approval: FDA can withhold approvals of generic drug applications if the
firm is under active criminal investigation for dishonest conduct involving its
drug applications (for example, bribery or material misrepresentations).
Withdrawal
of Approval: For a generic drug that's already been approved, FDA may
withdraw that approval if the company used bribery or fraud to get approval or
if the company can't produce the drug properly.
2.FDA
Import Alert:
The
company's product (or products) may no longer be imported into the United
States. The goods remain at customs. An import alert allows FDA to detain,
without physically examining; products that either have or potentially could
violate the Food, Drug, and Cosmetic Act.
3.Debarment
of Individuals and Firms:
Permissive
Debarment of Individuals: FDA has the option to debar, for up to
five years, individuals convicted of certain crimes, described in the act, that
are related to the regulation of drugs but do not require mandatory debarment.
In January 1997, FDA used this authority for the first time, debarring the head
of a blood plasma facility convicted of falsifying blood records.
Debarment
of Firms: Firms are also subject to mandatory or permissive debarment.
They can be prohibited from submitting applications for generic drug approval
(in this case, the law lives up to its name and only applies to generics) for
certain crimes relating to the development or approval of generic drug
applications. They can be debarred for up to 10 years, depending on the
seriousness of the crime and other factors, and they can be debarred
permanently if they are convicted a second time while debarred.
4.Civil
Penalties:
Besides
fines for violating a debarment, fines of up to $1 million may also be imposed
on a company for bribery, false statements, or other wrongful conduct involving
a generic drug application.
5.Suspension
of Distribution:
FDA
can suspend marketing of some or all of a company's drug products if the
company is under investigation for certain conduct that may influence the
safety or effectiveness of a drug.
Reference
Investigators
Operations Manual
Regulatory
Procedures Manual
http://www.fda.gov/ora/compliance_ref/rpm/default.htm
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