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Lester M. Crawford, D.V.M., PhD - Pharmaceutical Education Associates

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
Pharmaceutical Education Associates

Remarks by
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs

March 22, 2005

Good morning and thank you Retta (Riordan) for your kind introduction. I am pleased to be here to discuss a very important topic for the FDA – Our work to combat fraud and abuse in the drug industry.

FDA’s primary mission is to protect the public health and one of our top priorities in achieving that mission is to reduce risks associated with FDA regulated products. We have made great strides in the recent year to ensure quality in drug products and we will continue to look for ways to reduce risks for patients and consumers.

I want to discuss three specific areas of enforcement that FDA is implementing to preserve drug product integrity: counterfeit drugs (RFID), internet health fraud (dietary supplements), and misleading promotion (off labeling warnings).

COUNTERFEIT DRUGS

Counterfeiting of drugs is commonplace around the world. In some countries, you are more likely to get a counterfeit product than an authentic drug. Fortunately, the U.S. drug supply is among the safest in the world and has been relatively free of counterfeits because of a strong pharmaceutical regulatory system.

However, in recent years, we have seen a significant increase in counterfeit activities for drugs that are sold in high volume, and are high in cost. These counterfeits look deceptively authentic. We believe the increase can be attributed to well-funded counterfeiting networks and sophisticated technologies for copying drugs.

To combat this growing epidemic, the FDA issued a Counterfeit Drug Task Force Report in February, 2004 that set a framework for the Agency. It would secure the product and packing, secure the movement of drugs through the supply chain, secure business transactions, ensure appropriate regulatory oversight and enforcement, increase penalties, heighten vigilance and awareness, and strengthen international collaboration.

In November, 2004, FDA stepped up its effort by issuing a compliance policy guide to facilitate pilot projects for the use of Radiofrequency Identification (RFID) Technology in the pharmaceutical sector. RFID is the cornerstone technology in the fight against counterfeit drugs because of its ability to track, trace and authenticate packages of drugs.

Using state-of-art electronic technology on every product, RFID allows the creation of an electronic pedigree from the point of manufacture to the point of dispensing. An electronic pedigree is a record of all the places where drugs have been and who has had it. It will minimize fraudulent mishandling and mischief to occur to tagged drug products.

I announced a few months ago that Pfizer and Purdue Pharma have already joined FDA action in implementing RFID and more are following suit. The FDA expects to see widespread adoption of RFID technology by the pharmaceutical industry by the year 2007.

The use of innovative technologies to protect the public health is exactly the type of bold leadership we hope to see more of in this arena and we hope that other manufacturers, wholesalers, and retailers will follow this example by also becoming early adopters of RFID. We have made a lot of progress moving the recommendations of the task force forward. We plan to issue a one-year update shortly listing these accomplishments.

INTERNET HEALTH FRAUD

Another major initiative undertaken by the Agency last year was our crackdown against dietary supplement manufacturers who make false or misleading claims on their products over the internet.

In this effort, FDA and the Federal Trade Commission (FTC) formed a Dietary Supplement Enforcement Group to closely coordinate our enforcement efforts against fraud.

As part of this group’s effort to curb internet health fraud, FDA has conducted several “surfs” to identify fraudulent marketing of health care products, including dietary supplements. Just in October, the FDA’s Center for Food Safety and Nutrition (CFSAN) sent nine warning letters to dietary supplement manufacturers for unsubstantiated claims on dietary products promoted for weight loss over the internet.

In November of last year, we issued a draft guidance on substantiating claims made for dietary supplements. We expect to finalize this guidance later this year.

Our strategy for enforcement, which includes cooperation with the FTC, other federal and state authorities, and international organizations, targets adulterated substances and products marketed as dietary supplements making claims for treatment of serious diseases such as cancer and diabetes. While we believe that in general, most of the dietary supplements already on the market are safe, the FDA will continue to monitor and evaluate dietary supplement labeling and advertisement, including literature such as flyers, brochures, and catalogs. We will take enforcement action whenever necessary to protect patients and consumers.

MISLEADING PROMOTION

Finally, while the FDA does not regulate the practice of medicine (how health care professionals make informed prescription decisions for their patients), the agency has regulatory authority over how industry promotes prescription drugs. FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) plays an active role in monitoring prescription drug promotion and enforcing the provisions of the statute and regulations covering advertising and labeling. Two examples of recent DDMAC actions are warning letters to Novartis Corp for its Diovan sales aid and Cubist Pharmaceuticals for its Cubicin advertisement.

Diovan

On April 21, 2004, DDMAC issued a warning to Novartis on its sales aid that claimed that Diovan is effective in treating patients with type 2 diabetes and hypertension to preserve renal function.

Diovan’s approved labeling does not include any benefits related to this claim and, to our knowledge, this has not been demonstrated by substantial evidence or clinical experience.

Our letter asked the company to immediately cease the dissemination of all promotional materials for Diovan that contain such claims and to provide a plan of action to disseminate accurate and complete information. Failure to correct the violation could have resulted in FDA regulatory action, including seizure or injunction without further notice.

Cubicin

A similar event happened with Cubicin. In August 2004, DDMAC sent a warning letter citing a professional journal ad for Cubicin which failed to reveal any important risk information associated with the use of Cubicin and, therefore, misbranded the drug. Additionally, the Cubicin website promotion was misleading because it broadened the indication for the drug, by implying that Cubicin was safe and effective and FDA-approved for all infections caused by MRSA and MSSA when this had not been demonstrated by substantial evidence.

The ad also made misleading superiority claims to other products when this had not been demonstrated. FDA believed these violations posed serious public health and safety concerns because the inappropriate use of Cubicin can result in therapeutic failure and increases in morbidity and mortality in infections for which Cubicin has not been proven safe and effective.

These are just two examples of the enforcement actions we take to combat false and misleading promotion.

CONCLUSION

Once again, I want to stress that the FDA is committed to ensuring the safety of products we approve for patients and consumers. Thank you again for having me here to discuss this very important matter. I look forward to your questions.