Criminal prosecutions are relatively rare because the various remedies at FDA's disposal, such as recalls and seizures, and the bad publicity that violations of the Act can generate and the desire of most companies to comply with FDA regulations are sufficient to ensure, if not complete compliance with FDA requirements, at least an honest effort by the vast majority of companies and individuals working in FDA-regulated industries.
Biologic, Drug and Device manufacturers should be inspected at least once every 2 years, but the FDA acknowledges in its fiscal year 2003 Performance Plan that "only 22 percent of human drug, and 13 percent of medical device statutory establishments were inspected in [fiscal year] 2000."
According to the FDA Enforcement Story, the FDA carried out 18,649 inspections in 2002.
According to the FDA Enforcement Story, the FDA issued 7,683 Form 483s in fiscal year 2001 The FDA Enforcement Story is an internal FDA publication that can be requested by members of the press and public through the Freedom of Information Act.
Warning Letters are posted by the FDA. In 2001, the FDA issued 1,306 Warning Letters, according to a database maintained by warningletters.com.
According to the FDA Enforcement Story, in fiscal year 2001 there were 4,563 recalls of FDA-regulated products. Two-hundred forty four of these recalls were class I recalls, and of these 214 were recalls of food products. Three-thousand, three hundred twenty six recalls in 2001 were class II recalls, of which 1,513 were recalls of biologic products, 960 of medical devices, 396 of animal drug or animal food products, 289 of food products or supplements, and 168 of human drug products. Information about recalls, seizures, injunctions, and other enforcement action may be found in the FDA Enforcement Report.
Seizures of drug and biologic products are conducted under Section 304 of the FD&C Act and allow the FDA to take custody of the product after obtaining a court order or under section 304(g), which allows devices to be seized without a court order. The owner of the products can contest the seizure in court, agree to destroy the seized products, or take no action. The FDA received approval for 27 seizures in fiscal year 2001, according to the Enforcement Story.
Some of the powers just stated can be used by the FDA based on its delegated power under the FD&C Act. Other remedies, however, such as seizures or criminal prosecution will require the agency to go to court. The FDA's Office of the Chief Counsel helps ensure that the FDA complies with the law and reviews cases for prosecution (Warning Letter Review policy). If a matter must be prosecuted in court, the Department of Justice's Office of Consumer Litigation and U.S. Attorneys in the relevant location will represent the agency. The DOJ and FDA may obtain an injunction from the court ordering the company to perform or cease performing certain conduct.
In fiscal year 2001, 12 consent decrees of injunction were filed by the agency. Companies signing consent decrees in recent months include Schering-Plough (alleged good manufacturing practice violations); Watson Laboratories (relating to alleged good manufacturing practice violations); E'Ola International (marketing of ephedrine containing dietary supplements); and ElanHoldings, a subsidiary of Ireland's Elan Corp. (alleged good manufacturing practice violations). Another company, an Ohio-based medical device company, pleaded guilty to 6 misdemeanor violations and agreed to pay $1.2 million in fines to settle charges that the company failed to report adverse events and submitted "false and misleading" data about a clinical study in 1999 and 2000.
In 2002, the FDA also has sought a court order to hold the American Red Cross in contempt of a 1993 consent decree based on inspections of Red Cross facilities that allegedly "revealed persistent and serious violations of blood safety rules." The American Red Cross collects and processes donated blood.
Companies that repeatedly violate drug approval regulations may be placed on the application integrity policy list, under which the agency will defer review of drug applications from certain facilities or the entire company until corrective actions are taken. Companies and individuals also may be debarred if they have been convicted of violations of FDA regulations, effectively meaning that they can no longer submit materials to the FDA or work for organizations that are regulated by the FDA.
The FDA may also disseminate adverse publicity about a company or product, and even if the agency does not publicize a matter, trade and business publications may report a company's violation of FDA regulations. But because of the great interest surrounding FDA-regulated products on the part of both consumers and investors, in many cases the national or local TV, radio, and newspapers have already broken a story even before the FDA has issued a press release. Adverse publicity can affect the company's stock price and undermine the trust of its customers, both lay and professional. To cite a recent example, when Schering-Plough recently agreed to pay $500 million to the FDA for alleged violations of good manufacturing practice regulations, major newspapers covered the story (FDA, Schering-Plough Signs Consent Decree, 2002). Because the consent decree was expected to, and ultimately did, result in large fines, stories concerning the company's alleged violations and the ongoing consent decree negotiations between the FDA and Schering-Plough attorneys was the subject of many news reports even before the decree was finally signed. Since May 2002, the company has been forced to comment on the consent decree in conferences with shareholders.
Companies also may have approvals withdrawn or review of pending applications suspended until violations are corrected.
The Enforcement Story reports that in fiscal year 2001, the OCI was responsible for 422 arrests, 360 convictions, and $100 million in fines and forfeitures.
Case law has established that under the legal principle of strict liability company officials may face criminal charges for violations of the law by their companies even if they are not aware of the violations or violations result from the actions of lower level employees.
For more information, see the list of laws enforced by the FDA and information about inspections and good manufacturing practice regulations.
http://www.fda.gov/opacom/laws/
http://www.fda.gov/ora/inspect_ref/iom/iomtc.html
For every dollar that goes to vitamins, 1 million goes to the drug industry.... of courses doctors are all for this... it means more money in their pockets...
. Can you imagine "boot legged Vitamins"? 
