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FDA Advances Consumer Health and Safety in 2003

The Food and Drug Administration (FDA) today released a white paper highlighting some of FDA's priorities and major initiatives to protect and advance consumer health and safety in 2003, and describing how the agency intends to build on many of these initiatives in 2004.

The major consumer achievements noted in the paper, "Protecting and Advancing Consumer Health and Safety," include efforts to: bolster consumer safety through major industry regulations and risk communications; combat new forms of terrorism and emerging diseases; crack down on false products and false claims; reduce preventable medical errors; speed access to safe and affordable medicines; and help consumers improve their health through better information and greater "health literacy."

"Over the past 12 months, we have taken a number of unprecedented steps to defend Americans against increasingly sophisticated health threats and to open up all new opportunities for health innovation and improvement," said FDA Commissioner Mark McClellan, MD PhD. "These strategic initiatives were based on important feedback from the consumer and patient communities, and were developed and implemented in conjunction with a number of key healthcare partners. Thanks to strong leadership from President Bush and HHS Secretary Tommy Thompson, as well as strong efforts from all of FDA's professional staff, sound science and efficient risk management, we made tremendous progress toward key public health goals in 2003."

Bolstering consumer safety through significant
industry regulations and risk communications

Over the past year, FDA has issued comprehensive regulations that bring new levels of consumer protection and patient safety for Americans. These significant regulatory actions, along with various communications and guidances to industry and consumers, have improved the safety and security of all of FDA's regulated products.

Strengthening food safety and security -- most substantial expansion of FDA's food safety activities in three decades

• Four new regulations -- Interim final rules on Prior Notice of Imported Foods and Registration of Food Facilities; Proposed rules on Establishment and Maintenance of Records and Administrative Detention;
  • Comprehensive new information on food production and distribution for the first time
• CFSAN Adverse Event Reporting System
• Mercury Warning
• Listeria Risk Assessment

Most comprehensive regulation ever of potentially unsafe dietary supplements

• Landmark regulations to prevent risks of ephedra -- December Ephedra alert represents the first FDA enforcement action under the 1994 dietary supplement law
• Comprehensive new proposed regulations for safe manufacturing and accurate labeling for entire dietary supplement industry

Protecting Americans from unsafe drugs and biologics

• Proposed amendments to safety reporting requirements
• Antimicrobial guidance

Promoting more balanced, informative advertising and claims

• Public meeting on direct-to-consumer (DTC) advertising
• Development of new guidances for industry to improve communication to consumers

Protecting Americans from new forms of terrorism and emerging diseases

In the wake of September 11th, 2001, Americans face new, sophisticated threats of terrorism, including risks posed by the possible contamination of the nation's food supply. Consumers are also confronted with deadly emerging diseases like SARS and the West Nile Virus. In direct response to these heightened threats, over the past year FDA has implemented a number of fundamental enhancements to the Agency's food and medical safety activities.

Countering bioterrorism

• Four new food security regulations (referenced above)
• Collaboration at our borders and beyond
• Stronger FDA team to implement counterterrorism initiatives
• Significant increase in monitoring and enforcement; includes five-fold increase in the number of field examinations of imported foods (78,000) over the past year

Combating emerging diseases

• New blood safety and screening initiatives to stem the spread of deadly diseases -- includes new guidances on donor suitability and collaboration on the development of diagnostic tests for SARS and the West Nile Virus
• Comprehensive prevention program to stop BSE

Speeding the development of safe countermeasures to improve protection against terrorism and emerging diseases

• Guidance on "Prussian Blue"
• Support for Project BioShield for development of new countermeasures
• New, improved vaccines for infectious diseases and terror threats
• Good manufacturing practices to ensure safer countermeasures

Cracking down on false products and false claims

Over the past 12 months, the FDA has been active on enforcement to protect consumer health and safety. The Agency has used the full range of its enforcement tools to get the most "bang for the buck" in terms of protecting the public health. In 2003, FDA made particular headway in addressing two serious, growing threats -- counterfeit and unsafe drugs and false claims.

Strengthening enforcement actions where they matter most (FY03 data)

• 341 arrests and 199 convictions, amounting to more than $800 million in fines and restitution -- second highest monetary total ever
• 17 injunctions of firms/individuals -- highest in the last eight years
• Approximately 392 criminal cases opened
• 25 seizures of violative products
• More than 500 Warning Letters

Preventing counterfeit and other unsafe drugs

• Counterfeit Drug Task Force to identify 21st century solutions
• Increase in counterfeit drug investigations to stem illegal activity
• Major enforcement actions to crack down on offenders
• Includes Warning Letters, injunctions and indictments against numerous individuals and corporations
• Stronger protections against drug imports

Countering false claims

• Major enforcement initiatives against dietary supplements making false claims
• Updated and enhanced enforcement on other violative advertising and claims

Reducing preventable medical errors

Every year, Americans suffer needlessly from avoidable medical errors. Preventing adverse medical events is a top priority at FDA, and over the past year, the Agency has introduced a number of new regulations and solutions that are estimated to reduce adverse events, save lives, and generate huge savings in health care benefits. As a result of these new strategic initiatives, more programs are now in place to improve consumer safety than at any time in the Agency's history.

Modernizing regulations and improving surveillance to improve health and save lives

• Bar coding of drugs and biologics to enhance patient safety
• Electronic prescribing to eliminate adverse drug events
• "Active" reporting systems to better track adverse events

Individualizing medicine through pharmacogenomics

• New industry guidance on using pharmacogenomic information in product development

Proposing new safety standards

• Proposed amendments to the federal radiation-safety standard for diagnostic x-ray equipment
• Antibiotic labeling to prevent drug-resistant bacterial strains

Speeding access to safe and affordable medicines

The biomedical development process is more costly, more difficult and more uncertain than ever before. As a result, there are fewer new medical products reaching consumers than at any time in more than a decade. At the same time, Americans are also facing unprecedented challenges involving affordability and access to the treatments that do make it onto the market, especially prescription drugs. Many Americans cannot afford the necessary treatments for their health ailments, and are unable to realize the full benefit of the products that are available.

FDA has taken a number of unprecedented actions over the past year to speed access to safe and affordable medical products and to get critical treatments in the hands of Americans who need them.

Saving consumers billions by increasing access to generic drugs

• New regulations and systems to speed access to generic drugs when legitimate patents expire
• Enhanced public education and scientific study of generic drugs

Getting treatments to patients faster by speeding innovation

• Reduction of multiple cycle reviews
• Development of "quality systems"
• New guidances in critical medical areas
• Collaboration with National Cancer Institute (NCI)

Helping consumers improve their health through better information and greater "health literacy"

A well-informed public is one of the best defenses against public health problems facing the country. Recognizing this fact, the FDA has undertaken a number of initiatives in 2003 to provide better health information and help consumers make better choices.

Better information for better nutrition

• Improving health claims and food labeling
• Trans-Fat Labeling to improve nutrition and reduce heart risk
  • First significant change on the Nutrition Facts panel since it was established in 1993
• Formation of Obesity Working Group to explore new solutions for nutrition
• Nationwide education campaigns to reach out to all types of consumers
  • Collaboration with Administration on Aging on Hispanic health
  • "The Power of Choice" (after-school, healthy lifestyle program)
  • Web education for older Americans
  • Trans fat consumer education program
  • Emergency consumer alerts such as on shellfish safety, Listeria, and mercury in fish

Better information for safer medical usage

• Collaboration with industry and consumers for better medication information
• FDA.Gov for online medical information
• Nationwide medical education campaigns
  • Menopausal hormone therapy campaign
  • Gene therapy education campaign
  • "My Medicines Pocket Medication Guide"
  • "FDA & YOU" newsletter
  • Expansion of "Patient Safety News" monthly web broadcasts

A copy of the complete report can be obtained on the FDA Web site at www.fda.gov/oc/whitepapers/consumers.html.

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Protecting and Advancing Consumer Health and Safety

HHS-wide highlights for 2003

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