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The FDA Pursues an Aggressive Enforcement Strategy - to protect the public health  - June 30, 2003

If you have not realized it, the U.S. Food and Drug Administration is letting it be known through a white paper report that they have a renewed committed to pursuing Federal Food, Drug, and Cosmetic Act violations.  Enforcement activities include warning and untitled letters, injunctions, recalls, arrests, and convictions. Overall, these point to dramatically increased enforcement, particularly in areas related to the most serious threats to public health, such as arrests and convictions on criminal charges involving potentially dangerous activities and actions against manufacturers making misleading claims about product risks and benefits.

FDA's most decisive actions, those that remove products from the market and that bring criminal charges against people who would harm the public, have increased the most. Data from fiscal years 1998 to 2002 show:

• Injunctions rose from 11 to 15
• Recalls increased from 3532 to 5025
• Arrests went from 250 to 286; and
• Convictions went from 194 to 317

The last number, convictions is the most impressive one. The FDA does take companies and their officers to court for criminal violations.

FDA's enforcement activities also include letters to product manufacturers whose products are not inherently unsafe, but who engage in promotional activities that are misleading or not truthful. While letters themselves do not represent legal action, FDA has enhanced the legal foundation of the letters it issues so that they can provide a solid basis for court action. [This process, accomplished through review and enhancement of the letters by FDA's Office of Chief Counsel, has not appreciably reduced the number of letters on promotional activities being issued. For example, the Office of the Chief Counsel concurs with issuance of 95 percent of the draft letters of FDA's DDMAC.] So far this year alone, FDA has issued a dozen letters warning companies about misleading promotions of pharmaceutical products, including:

• Allergan, Inc. (BOTOX COSMETIC)
• Amgen, Inc. (Procrit)
• GlaxoSmithKline (Flonase)
• Serono Laboratories, Inc. (Rebif)
• Genpharm Inc. (Amnesteem)
• Novartis Ophthalmics, Inc. (Zaditor)
• Centocor, Inc. (Retavase)
• Cangene Corporation (WinRho SDF)
• Hoffman-La Roche Inc. (Xeloda Tablets)
• Aventis Behring L.L.C. (Gammar-P I.V.)
• Purdue Pharma L.P. (OxyContin)
• BERLEX Laboratories (Climara)

In some cases, the letters have required the drug manufacturer involved to take high-impact corrective actions, e.g., Purdue Pharma was required to place prominent magazine advertisements that correct the misstatements in previous advertisements. FDA's ability to get companies to comply is enhanced by a commitment from the agency to pursue legal action if the company does not address the issues raised in the letter. Finally, to deter misleading ads in the first place, to provide an even clearer basis for enforcement activities, and to help make sure patients get an accurate picture of risks and benefits of a drug, FDA expects to issue clear new guidance on communicating risk and benefits in DTC ads later this year.

FDA is also committed to enhanced enforcement activities to protect the public health from unsubstantiated medical claims by dietary supplement distributors. FDA enforcement activities in this area include inspections, warning letters, seizures and injunctions, and criminal enforcement. In the past year, FDA has acted against the following categories of products: ephedrine, Coral Calcium, SARS products, and SeaSilver. The FDA is particularly vigilant regarding dietary supplements that have no proven benefits yet nonetheless make misleading claims to prevent, treat, or cure serious medical conditions, including:

• Treatments for life-threatening diseases
• Weight Loss products
• Autism treatments
• Treatments for behavioral disorders
• Treatments for SARS
• Treatments for other viral illnesses
• Treatments for mental retardation and Down's Syndrome
• Colloidal Minerals
• Supplements for smokers
• Supplements for drinkers

Such claims not only cause consumers to waste their money; they also represent significant public health threats because they may deter consumers interested in protecting their health from using treatments that actually work.

The FDA is also increasingly leveraging the impact of its activities through partnerships with other consumer protection and law enforcement agencies. For example, the FDA works closely with the Federal Trade Commission (FTC) under a liaison agreement that coordinates FDA's authority over claims on product labeling and FTC's authority over advertising claims. An ongoing collaboration between the FDA and the FTC is Operation Cure.All. Through coordination of the activities of the FDA, FTC, Health Canada, and various state Attorneys General, Operation Cure.All is an ongoing law enforcement and consumer education campaign against the fraudulent marketing of supplements and other health products on the Internet. The FDA also works with the U.S. Customs Service to ensure that certain imported goods are targeted for automatic detention.

FDA's most serious enforcement activities are having unprecedented success. A noteworthy string of record-breaking penalties against medical product manufacturers have resulted from FDA enforcement actions and Federal investigations that involved FDA in the last two years, including two major actions this month. These include:

• $879 million settlement for conspiracy to commit violations of the Prescription Drug Marketing Act--TAP Pharmaceuticals (October 2001)
• $500 million for failure to comply with Good Manufacturing Practices--Schering Plough (May 2002)
• $355 million settlement for health care fraud--AstraZeneca (June 2003)
• $92.4 million for failing to report malfunctions of a medical device to the FDA--Guidant (June 2003)
• $33.1 million in fines and forfeitures for submitting false information to the FDA--Aventis Pharmaceuticals, Inc. (October 2001)
• $30 million for failure to comply with Good Manufacturing Practices--Wyeth Ayerst (October 2000)
• $4.7 million in restitution for resale of pharmaceuticals--Northland Provider (August 2001)

FDA has also enhanced its criminal enforcement activities related to drug counterfeiting and to unsanitary foods.

FDA encourages those interested in learning more about the agency's enforcement record to consult the FDA website at www.fda.gov

      If you have any questions on how these numbers effects your operations please contact mdi at info@mdiconsultants.com.

.S. AGENT SECTION

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