Enforcement injunctions

The tliird major set of amendments was the Federal Facility Compliance Act of 1992. Tliis aet resoh es the legal question of w hether federal faeilities are subjeet to enforcement actions under RCRA by wai ing the go crnmcnt s so crcign iimnunity from prosecution. As a result, states, USEPA, and the Department of Justice can enforce the pro isions of RCRA against federal facilities, and federal departments and agencies can be subjected to injunctions, administrative orders, and/or pciuiltics for noncomplianec. ... 

In fiscal year 2005, the FDA field office conducted 1437 cGMP inspections, resulting in 15 warning letters, six injunctions, and one seizure. These enforcement actions are discussed later in this chapter. Data for the years 2000-2005 are set forth in Figures 1 and 2. 

Upjohn filed suit in the U.S. District Court of the Western District of Michigan to stop the FDA from removing the drugs and named Robert H. Finch, secretary of health, education, and welfare, and Herbert L. Ley, commissioner of the FDA, as defendants. With sales of the drugs reaching 30 million a year, Upjohn had a considerable stake in the case. The district judge issued an injunction to prevent the FDA from enforcing its order and then considered the merits of the suit. 

The legislation went into effect on December 10, 2005, with several provisions for enforcement. Any person in the District of Columbia who is adversely affected by the excessive prices could file suit. Remedies included an injunction to stop sales of the prescription drug, and payment of fines, damages, attorneys fees, or court costs. 

The Circuit Court panel, by a 2-1 vote, ruled that the Controlled Substances Act was intended to apply to interstate commercial trafficking in illicit drugs. It did not apply to drugs produced entirely within a state for personal medical purposes. The panel ordered the case returned to the district court for final determination, with a preliminary injunction issued barring enforcement of the CSA. Meanwhile, federal prosecutors appealed to a full panel of the Ninth Circuit. 

During my tenure with the Center for Medical Devices, I was part of several injunctions that were referred to as corporate or corporatewide injunctions. These actions were intended to address what the agency believed to be a corporate culture that permitted, and possibly encouraged, company noncompliance. Corporate injunctions were invoked when compliance problems were found in different facilities of the same company. A pattern of noncompliance and negligence on behalf of the parent company led the agency to consider a corporate injunction as the regulatory enforcement tool. Corporate injunctions typically include the corporate parent, its senior officers, and all of its facilities around the world. It usually requires that some of those facilities cease operations for some period of time until compliance is achieved. Its characteristics are similar to the traditional injunction, with the exception that this particular enforcement targets the corporate umbrella. 

A recall is a removal or correction of a marketed product by the pharmaceutical manufacturer when that product violates the laws enforced by the FDA. Unlike the FDA s other methods for achieving compliance such as seizures and court-ordered injunctions, recalls are almost always voluntary. The FDA cannot order a company to recall a product, except in some cases involving infant formulas, biological products, and devices that present a serious health hazard. A class I recall occurs when there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. A class II recall occurs when use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote. A class III recall occurs when... 

Potential penalties for misbranding violations include injunction proceedings, civil penalties, seizure proceedings and even criminal prosecution. The US government is responsible for the enforcement of the FDCA and FDA regulations. 

FDA also has statutory authority to request the Department of Justice to seek a court injunction against continued violations of the law by a prescription drug manufacturer or distributor. FDA has had mixed results in attempting to obtain injunctions from the courts, who realise that an injunction can shut down a company entirely or subject it to arbitrary demands by FDA. FDA has therefore sought to obtain the equivalent in the form of stipulated agreements with companies that are filed in court as consent decrees and thus are fully enforceable as a requirement of law. 

While all such enforcement actions may be appealed in the Federal Court, it is usually only the last of these, forced product withdrawal, that justifies the time, expense, and uncertainty of such legal action. Drug products usually remain off the market under temporary injunction while such proceedings take place, and this prolonged period per se is often sufficient to kill the product for economic reasons. The more serious of these enforcement actions is also punishable with prison terms and fines under the Food, Drugs and Cosmetics Act. A large inspectorate is distributed throughout the USA and around the world as part of FDA s enforcement arm. 

Administrative penalties for violation of the polymer exemption are assessed in accordance with the 5 Enforcement Response PoHcy ( 5 ERP).i The EPA has the authority to seek injunctions and seize products that were made in violation of the terms of the exemption, but typically considers civil enforcement actions to be sufficient to compel compliance. ... 

While EPA may seek broad forms of mandatory injunctive relief under TSCA, private plaintiffs can only seeka restraint of ongoing violations. Additionally, private plaintiffs cannot enforce the penalty provisions as a method for recovering compensatory damages. ... 

The ERA can seek injunctions under AHERA if a violation poses an imminent and substantial endangerment to human health or the environment. Most of the enforcement options available for non-asbestos violations are also available for asbestos violations. For example, TSCA 16 authorizes the... 

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