Inspections, Compliance, Enforcement, and Criminal Investigations
In Fiscal Year 2003, the Food and Drug Administration (FDA) worked vigorously to accomplish the agency’s ongoing mission of protecting the health and safety of the American public. Since the tragic events of September 11, 2001, the challenges facing the agency have grown in monumental proportions. However, FDA’s enforcement accomplishments demonstrate that the challenges facing the agency are not insurmountable.
The Commissioner of Food and Drugs, Mark B. McClellan, M.D., Ph.D., identified five strategic goals for FDA in Fiscal Year (FY) 2003. In a comprehensive 5-part strategic action plan entitled, "Protecting and Advancing America’s Health: A Strategic Action Plan for the 21st Century," Dr. McClellan enumerated five strategic goals: 1) Efficient, Science-Based Risk Management; 2) Patient and Consumer Safety; 3) Better Informed Consumers; 4) Counterterrorism; and 5) A Strong FDA.
In announcing the strategic action plan, Dr. McClellan stated, "Today, we need a strong and effective FDA more than ever. This strategic action plan is our coordinated effort to respond to some of the most challenging threats and opportunities for public health that we have ever faced.”
Applying these principles to the enforcement of FDA laws, regulations and related statutes enabled the agency to sharpen its focus and clearly identify those areas that are the most critical to ensuring the health and safety of the American public.
In FY 2003, FDA achieved a number of important enforcement accomplishments in highly visible areas of concern to FDA and consumers:
Efficient, Science-Based Risk Management
- A study of ephedra, commissioned by the National Institutes of Health, entitled the RAND Study 1/ reviewed over 16,000 adverse events reported after ephedra use and found about 20 "sentinel events" including heart attack, stroke, and death that occurred in the absence of other contributing factors. It concluded that ephedra is associated with higher risks of mild to moderate side effects, such as heart palpitations, upper gastrointestinal effects, and psychiatric symptoms and also symptoms of autonomic hyperactivity, such as tremor and insomnia, especially when it is taken with other stimulants.
- On March 31, 2003, FDA announced enforcement actions against firms marketing street drug alternative products, including some containing ephedra or other sources of ephedrine. FDA sent warning letters to eight firms for marketing products that the firms claimed could be used as alternatives to street drugs.
UPDATE: On February 6, 2004, FDA published a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). The rule became effective on April 12, 2004.
Patient and Consumer Safety
- FDA Commissioner Mark B. McClellan submitted a progress report in July 2003, to the Department of Health and Human Services Secretary Tommy G. Thompson. This progress report entitled, "Ensuring the Safety and Security of the Nation's Food Supply," highlights the department's progress in making the food supply safer and more secure.
- For example, for Fiscal Year 2003, FDA quintupled the number of imported food examinations it conducted in fiscal year 2001 -- reaching 62,000 inspections at the half-way mark that year (July 2003), compared with 12,000 in all of FY 2001. The increase exceeds the agency's goal.
- The increased coverage reflects a steep increase in the number of ports of entry with FDA staffing from 40 to 90; FDA's intensive efforts during a period of heightened security alert earlier this year (Operation Liberty Shield); and enhanced collaboration with other government agencies to protect the food supply more efficiently.
- This progress stems in large measure from the $96 million increase in the agency's food-security budget achieved by Secretary Thompson in Fiscal Years 2002 and 2003. President Bush's Fiscal Year 2004 budget requests another $116.3 million to further protect the nation's food supply. 2/
- In September 2003, FDA formally warned a number of firms to stop their illegal sales of an unapproved, mislabeled version of the acne drug Accutane (isotretinoin). The agency believes that this illegal practice poses a serious health risk to patients. FDA urged patients not to use these illegal foreign versions of Accutane.
- As part of FDA’s ongoing efforts to investigate and address unscrupulous counterfeiting activities, FDA's Office of Criminal Investigation uncovered the existence of contaminated counterfeit Procrit during March 2003. Known as epoetin alfa, authentic Procrit is used to stimulate the production of red blood cells in humans to treat severe anemia.
- In FY 2003, FDA’s Office of Criminal Investigations reported 206 convictions for criminal activity. Many of these convictions for criminal activity involved distributing counterfeit drugs, tampering, illegal distribution of prescription drugs, and other criminal activity involving FDA-regulated products.
Better Informed Consumers
During Fiscal Year 2003, the FDA remained vigilant by keeping the public informed regarding products promising “cures” but in fact offering fraudulent products. In January 2003, FDA Commissioner Mark B. McClellan announced the formation of an internal FDA task force to develop scientific guidance for establishing standards for qualified health claims in foods. The FDA Task Force on Consumer Health Information for Better Nutrition is the key element of an initiative to make available to consumers more and better information about the health benefits of food and dietary supplements.
Launching new enforcement initiatives against dietary supplement manufacturers who make health claims without scientific foundation, the FDA is undertaking major new efforts to help consumers make better-informed decisions about how to use their health care dollars. An important focus for FDA in Fiscal Year 2003 was preventing the promotion on the Internet of violative and oftentimes dangerous products on the Internet. The Internet provides an anonymous, significant, and potentially dangerous avenue for illegal activity involving the promotion of unapproved foods, drugs (human and veterinary), medical devices, and dietary supplements.
- On July 22, 2003, a federal jury in Brooklyn, New York, convicted Jason Vale, president of the Queens based company Christian Brothers Contracting Corporation ("Christian Bros."), of three counts of criminal contempt. Despite a Court Injunction Jason Vale continued to promote Laetrile via the Internet, promising a “Cancer Cure.”
- Humphrey Laboratories of Lake Oswego, Oregon, doing business as Kirkman Laboratories, was promoting Kirkman’s HypoAllergenic Taurine Capsules as a treatment of autism. At the request of FDA, U.S. Marshals seized hundreds of bottles of Kirkman's HypoAllergenic Taurine Capsules. The firm had been fraudulently promoting the capsules on the Internet.
- On December 16, 2002, at the request of FDA U.S. Marshals seized approximately 3000 bottles, valued at more than $100,000, of EverCLR, a dietary supplement. EverCLR was deceptively marketed by Halo Supply Company of San Diego, California, as a "natural" treatment for viruses, including the herpes virus, and for "cold and flu protection."
- FDA increased inspections of domestic food facilities and sampling and laboratory analysis of foods produced here and abroad.
- Thanks to increased bioterrorism funding from Congress, FDA hired over 800 new inspectors and other field personnel to keep watch on imports and other avenues our enemies might try to use to contaminate our food or tamper with other FDA-regulated products. FDA has also increased inspections of facilities manufacturing medical products that could be used in response to a terrorism threat. 3/
A Strong FDA
By partnering with other federal, state and foreign governments FDA has increased the impact of its activities.
- In May 2003, FDA announced that the agency was partnering with the U.S. Bureau of Customs and Border Protection (CBP) in order to streamline the implementation of the prior notice requirements of the Bioterrorism Act, thereby allowing food importers to provide required information on food imports to both agencies using an integrated process.
- The FDA and the Federal Trade Commission (FTC) also continued their ongoing collaboration against health fraud, together with Health Canada, and various States Attorneys General in Operation Cure.all. "FDA and FTC are working together to maximize our efforts to combat heath fraud," said FDA Commissioner Mark B. McCellan. "We are trying to be particularly vigilant concerning fraudulent internet promotion, because this is emerging as an increasingly insidious way of trying to exploit the public." 4/
The above introduction does not cover other enforcement tools used by the agency to achieve compliance, such as Warning Letters and Untitled Letters, Voluntary Compliance, and Import Refusals.
While The Enforcement Story describes examples of noncompliance by regulated industry, we want to emphasize that we are proud of the vast majority of industry who share FDA’s commitment to the health and safety of the public and produce high quality products.
The information contained in this publication was obtained from various sources within the FDA throughout the course of the fiscal year 2003 (FDA’s Fiscal Year began October 1, 2002, and ended September 30, 2003). The document is updated up to the time of publication. While reasonable steps were taken to assure the information was correct at the time of publication, the statements in the publication may not contain all significant information on any cited account.
Further, this publication does not contain all enforcement actions undertaken by the FDA during the fiscal year. All items are presented in a summary form to convey the significance of the violation and /or court decision(s). The Enforcement Story is devoted to practical presentation of actual FDA enforcement actions that impact on the development, manufacture, distribution and marketing of foods, drugs, biologics, cosmetics and medical devices.
The Enforcement Story is intended as an internal publication to serve as an information source for FDA personnel. The statements made herein are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended merely for internal guidance.
DISTRIBUTION WITHIN THE FDA:
FDA personnel may obtain copies of The Enforcement Story by contacting the Division of Compliance Policy (HFC-230) in the ORA’s Office of Enforcement.
The public may only obtain a copy of The Enforcement Story by making a written Freedom of Information request submitted to the Food and Drug Administration, Freedom of Information Office, 5600 Fishers Lane, (HFI-35), Rockville, Maryland 20857.
Any comments as to how this annual publication may be improved are welcomed. Please send your comments to the Director, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, MD 20857.
1/ Rand Report: Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects (February 2003)
2/ HHS CREATES FOOD SECURITY RESEARCH PROGRAM, INCREASES IMPORT EXAMS MORE THAN FIVE TIMES TO PROTECT NATION'S FOOD SUPPLY Progress Report Details Ongoing Efforts To Enhance The Nation's Food Security News Release: See: http://www.hhs.gov/news/press/2003pres/20030723.html.
3/ FDA Counterterrorism Role. See: http://www.fda.gov/oc/bioterrorism/role.html.
4/ FTC and FDA Take New Actions in Fight Against Deceptive Marketing See: http://www.ftc.gov/opa/2003/06/trudeau.htm.