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Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

Federal and state laws and regulations relating to medicinal products create a number of federal and state authorities with compliance and enforcement responsibilities. The sale and distribution of medicinal products are also subject to laws of general application including federal and state antitrust and consumer protection laws. Government health programmes (eg, Medicare and Medicaid) have complex rules regarding reimbursement of covered products. Federal and state laws also contain fraud and abuse prevention laws, targeted at fraud and abuse in connection with programme benefits, including prescription drugs. Applicable laws include criminal and civil penalties, depending on the nature of the violation. In the case of licensure issues (whether individual or corporate), loss of licence and exclusion from applicable government health programmes are possible risks. State agencies, including those regulating the licensure of healthcare professionals, pharmacies and wholesale distributors, have regulatory and enforcement authority, as do state attorneys general.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The United States has strict antitrust rules that prevent collusion among competitors and laws against bribery both domestically and abroad (eg, the Foreign Corrupt Practices Act). The Food and Drug Administration has broad authority to investigate and, where appropriate, punish companies that falsify data in regulatory files. The risk of private civil litigation is also a strong deterrent. 

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