After Heparin: - The Pew Charitable Trusts

—Chapter 2—
3. Allow the FDA to refuse entry of a product if the site at which it was manufactured has
refused an FDA inspection. This will help the agency ensure that potentially compromised
products do not enter the United States and will incentivize foreign manufacturers to allow the
FDA to access plants and facilities.
4. Require importer registration. Tracking importers through a registration system will be an important
element of supply chain transparency and will offer a framework for importers to provide
more comprehensive documentation.
5. Permit the FDA to require more comprehensive documentation at import. The FDA should
have the authority to require parties importing drugs and ingredients into the United States to
provide more substantive information during the importation process. Documentation could also
demonstrate compliance with U.S. requirements on product identity, quality, safety, FDA approval
and FDA registration, as well as other categories at the discretion of the FDA.
E. Ensure the FDA has the regulatory authorities it needs to fulfill its mission
1. Provide the FDA with the authority to require drug recalls and order the cessation of distribution
in situations where a drug product could cause illness or injury. Mandatory recall
authority will help the FDA ensure patients are not exposed to harmful products, and will also
act as an important deterrent to refusing or delaying appropriate action. The FDA may order a
recall of medical devices, but may not do so for drugs, a significant limitation to its authority.
2. Provide the FDA with the power of subpoena. The ability to subpoena witnesses and documents
will help the FDA quickly investigate issues of medical product quality and safety that may
harm the public.
F. Strengthen the FDA’s enforcement ability through tougher penalties and clearer accountability
for industry
1. Strengthen both criminal and civil penalties for violations of the FDCA. With some exceptions,
current FDCA criminal penalties for knowing adulteration, misbranding and counterfeiting
of drugs are a maximum of $10,000 or three years in prison. Both financial penalties and allowable
prison terms should be increased for criminal violations, including drug and ingredient
adulteration caused knowingly or through negligence. Creating new administrative civil penalties
for violations of the FDCA will also help deter noncompliance and will give the FDA a much
more flexible enforcement arsenal. Currently for drugs, the FDA may assess civil penalties only
for violations of certain application requirements in the FDCA.
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Pew Health Group