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June 20, 2008 Volume 5, Issue 24
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  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.

Editorial: DTC Advertising!

Direct-to-consumer advertising from the pharmaceutical industry presents a number of problems to the profession and to society.

First, the ads are not always truthful; they tend to portray the drug-using individuals in a very positive light, do not portray individuals experiencing side effects (and even death), and the ads do not provide complete information. Looking at the previous ads for drugs that have been withdrawn from the market due to serious side effects and death, one must ask, "Why is the activity allowed to continue?" Are patients in a position to make a decision regarding their own therapy? (Obviously they are not trained to do this.) Do physicians yield to the requests of patients when they ask for a specific drug? (Yes, in many cases they do.) Are the ads intended to enhance healthcare? (No, they are intended to sell drugs.)

Second, direct-to-consumer advertising has brought many "embarrassing situations" into our living rooms during family time together while watching television. It appears the pharmaceutical industry is more interested in making a dollar than supporting family values. Why is it that erectile dysfunction ads need to be blasted into homes several times every single night? Why is it that female products need to be advertised when children are watching television? Where is the social value of this type of advertising? Obviously, it is only intended to sell drugs at any cost to social values.

Do you see drugs advertised on television that will treat cancer�epilepsy�wounds? No, you see drugs advertised where the patient will have an interest in requesting the drug from their physician. Surely, there must be a better way, and the millions spent on marketing could be used to decrease the high cost of drugs. I have heard statements that more money is spent on marketing than is spent on research on new drugs.

Maybe it's time we consider doing something about direct-to-consumer advertising of some drug products. We may consider having the potential to block offensive advertisements on television! If offensive portions (language, sex, violence, etc.) of programming can be blocked, why not have the opportunity of "blocking offensive advertisements?" Or maybe we should have the ability to "block ALL advertisements"!

True, as some have suggested, we could turn off the television during commercial breaks, but that suggestion is impractical as these offensive advertisements air without warning.

It is interesting that as part of an ongoing investigation, representatives Dingell and Stupak have requested improved accuracy and stronger guidelines for DTC advertisements. Maybe we should put in our two cents worth and request some additional changes be made.


Loyd V. Allen, Jr., PhD, RPh

 
USP Notification

Because USP Chapter <797> is now official (June 1, 2008), USP has taken down the chapter which was posted [and has been] on USP's website since December of 2007. USP is removing the chapter from the website for several reasons:

  1. It is included in the <797> Guidebook which is available and sells for $99. The Guidebook contains USP General Notices, Chapter <797> (2008), and Committee comments on the proposed revision which was published on USP's website in 2006.
  2. It is included in the Pharmacists' Pharmacopeia of 2008 which is available and sells for $250. The Pharmacists' Pharmacopeia contains the previous version (2004) of Chapter <797>, the current (2008) Chapter <797>, all the chapters referenced in Chapter <797>, chapters and monographs that relate to pharmacy practice, as well as other informative references.
  3. It is also available in the second supplement to USP 31/NF 26. The second supplement to USP 31/NF 26 contains only [the] Chapter <797> 2008 version.

Please note that in order to fully utilize Chapter <797>, the referenced USP chapters mentioned in it need to be accessible. The only way to gain access to these chapters is to purchase the Pharmacists' Pharmacopeia.

Source: Claudia Okeke, PhD.; United States Pharmacopeial Convention, Rockdale MD.

 
Other News

Legislation is being introduced stating that a patient's ability to file a lawsuit against a device company is not pre-empted by FDA regulation. The bill is scheduled to be introduced before the July 4 recess and is in response to a Supreme Court ruling in February that said patients may not file such lawsuits.
http://www.nationaljournal.com/congressdaily/cda_20080604_4132.php

U.S. Lawmakers are inquiring into the management and priorities of the FDA's Office of Criminal Investigations. The office has seen a doubling in its budget from fiscal year 2000 to 2009 but has had a 20% decrease in arrests and convictions even though they have had a 50% increase in the number of investigators from 2000 to 2006.
http://online.wsj.com/article/SB121314729048063047.html?mod=dist_smartbrief

Canadian CRO Laboratory said Akela Pharma has sent notice of intent to start legal recourse against its subsidiary that conducted studies in Hungary and the studies were rejected earlier this year by the FDA. The FDA deemed the drug studies as invalid. In addition to the client requesting the reimbursement of the costs of the studies, which totaled 2.74 million Euros, the client is also seeking payment of the costs to repeat the studies, estimated at US$5 million, as well as damages in the amount of US$20 million representing the licensing fees the client claims it would have received from a potential partner.
http://pharmalive.com/news/index.cfm?articleID=548053&categoryid=9&newsletter=1

 
Did You Know?

The HHS has asked for an extra $275 million for the FDA to help with import inspections and food safety. Presumably this will allow the FDA to conduct at least 1,000 more foreign inspections of food and medical product facilities and an additional 1,000 domestic inspections. $275 million divided by 2,000 new inspections is $137,500 per inspection.

 
Future Articles of Interest

As part of our ongoing efforts to keep compounding pharmacists up to date on Chapter <797> standards, to include revisions to the Chapter, the International Journal of Pharmaceutical Compounding's May/June 2008 issue featured an article titled "Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards." The most recent changes to Chapter <797> of the United States Pharmacopeia-National Formulary initiated an intense controversy about the frequency of cleanroom air sampling that is required to prevent the contamination of sterile preparations. The information contained in Part 1 was to assist compounding pharmacists in their efforts to search for the air sampler that provides the needs of each specific pharmacy. Part 2 of this article will be featured in our July/August 2008 issue, which includes discussions from compounding pharmacist on their experiences with air-sampling equipment.

 
Compounding Tip of the Week

Read between the lines and also find out who is speaking!
Sen. Chuck Grassley, Senate Finance Committee member, recently requested a probe into FDA's accelerated approval of Avastin for breast cancer. This request came under fire in a column in the Wall Street Journal by a "former FDA official, who is now a PHARMA exec."

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