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Beware the FDA & its "aggressive enforcement strategy".

On June 30, 2003, The FDA released its latest data on its enforcement activities, and folks, I gotta tell ya, it's NOT pretty. For decades, almost everyone in the medical industry with half a brain has been basically (and perhaps correctly) institutionally scared of the FDA. Some of that attitude has been warranted, and some not.

It Isn't Always Being Paranoid

I wouldn't quite call it being paranoid. Being paranoid, from my perspective, is being unduly scared about them being imminent inspections and microscopic FDA oversight of your operations. The FDA's newly-released statistics show that those who have been scared, as well as prognosticators like myself saying them is just cause to feel that way, may now have the data to validate their positions and feelings.

Some might call it, "I told you so, I wasn't paranoid afterall." Others would keep yelling, "there's no proof: show me the proof." Well, here's the proof. Data from fiscal years 1998 to 2002 show:

* Injunctions rose from 11 to 15

* Recalls jumped from 3532 to 5025

* Arrests rose from 250 to 286

* Convictions leaped form 194 to 317

What Are the FDA's Actions

As FDA officials note, "'Enforcement activities include warning [lettersl 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."

False & Misleading Claims

The FDA's enforcement activities also include letters to product manufacturer "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, the FDA has enhanced the legal foundation of the letters it issues so that they can provide a solid basis for court action."

FDA officials hole that 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 instance, the FDA Office of the Chief Counsel concurs with issuance of 95% of the draft letters of FDA's DDMAC. So far in 2003, the FDA has issued 12 letters warning companies about misleading promotions of pharmaceutical products.

The FDA's ability to gain compliance by companies, "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 determisleading 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, the FDA expects to issue clear new guidance on communicating risk and benefits in DTC ads later this year."

The FDA's most serious enforcement activities are having unprecedented success, official stress. A noteworthy string of record-breaking penalties against medical products manufacturers have resulted from FDA enforcement actions and federal investigations that involved the FDA during the past two years. These include:

* $879 million settlement for an alleged conspiracy to commit violations of the Prescription Drug Marketing Act--TAP Pharmaceuticals (October 2001)

* $500 million for allegedly failing to comply with Good Manufacturing Practices--Schering Plough (May 2002)

* $355 million settlement for alleged healthcare fraud--AstraZeneca (June 2003)

In conclusion, is a healthy dose of paranoid-ism what separates those companies that have been targeted, and those that have not? One has to wonder.

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David G. Anast is the founder of Biomedical Market Newsletter, Inc. in Costa Mesa, CA. Any questions or comments? 800-875-8181; 714-434-9500; Fax: 714-434-9755;
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Title Annotation:FDA Update
Author:Anast, David G.
Publication:Medical Design Technology
Date:Aug 1, 2003
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