The FDA has ratcheted up its regulatory enforcement posture over the past several years. The agency has increased its inspection
of firms, especially where there are product complaints, recalls or where there is a history of repeated, violative inspectional
observations. Although FDA has a number of enforcement tools available, including, Untitled Letters, Warning Letters, seizures
and injunctions, there has been an increase in FDA's use of consent decrees as a means to compel firms and responsible individuals
to comply with cGMPs, quality system requirements (QSRs), FDA regulations, and the Federal Food, Drug, and Cosmetic Act (FD&C
Act). The provisions of these consent decrees are particularly onerous and it takes considerable time and resources to meet
the required terms and conditions, which if met, allow the company to return to full, independent manufacture and distribution
David L. Rosen
Firms that enter into these agreements often feel that they will spend an inordinate amount of time and capital but ultimately
never be able to satisfy FDA requirements and resume manufacturing at their facilities. It is important to realize however,
that firms who market pharmaceuticals, biologicals, and medical devices are in a highly regulated industry and are required
and expected to have the infrastructure and controls in place to produce products that meet appropriate quality standards.
Such product quality standards are in the interest of public health and safety.
CONSENT DECREE PROVISIONS
If a firm has repeatedly violated cGMP requirements and wants to settle the issues with FDA, entering into a consent decree
agreement provides the firm with the opportunity to remedy cGMP deviations. Consent decrees are enforced by the federal courts.
The decrees provide terms and conditions that must be met to address, among other items, products in the commercial market,
finished products under the companies ownership and control, products in various stages of production, and all components
in the facility. In addition, companies generally have to provide a detailed going-forward workplan that outlines independent
third-party audits, changes in procedures, revalidation of processes, and certification that new batches that have been made
are in compliance with cGMPs.
Carrying out these steps can be a lengthy process. It frequently takes FDA a period of time to review, provide comments, and
hopefully approve the remediation and going-forward workplans. This review-time period can often be frustrating to companies
who want to get back into business to generate revenue to pay for the comprehensive and costly activities that they are undertaking
to meet the requirements of the consent decree.
Consent decrees typically include civil monetary penalties, reimbursements to the government for inspection costs, due dates
for specific actions, and penalties for noncompliance. Decrees are usually permanent, but at times specified in the agreement,
the firm can petition the court to vacate the decree if it has achieved compliance. In general, it is difficult to get the
government and the courts to support the vacating of such decrees. Firms must demonstrate compliance with FDA requirements
for a sustained period of time in order to make a reasonable case that they have the infrastructure and controls in place
to operate in accordance with the law and regulations.