Editorial: Twelve "Whereas's" and 1 "Be it Resolved"!

Twelve "whereas's" and one "be it resolved" is the composition of a Concurrent Resolution prepared by the U.S. House of Representatives concerning FDA's new policy restricting women's access to medications containing estriol. The resolution states that FDA's new policy does not serve the public interest.

It borders on being absolutely ridiculous, and even absurd, that the apparently unfounded decision of a "few FDA bureaucrats" has cost hundreds of thousands, or even millions of dollars of professionals' and citizens' time. Based on the FDA's decision, some insurance companies no longer pay for estriol-containing prescriptions, thus forcing the patient to pay.

A couple of weeks ago, Senator Tom Coburn sent a letter to the FDA listing 5 requests. Numbers 3, 4, and 5 are repeated below:

3. Documentation of specific adverse events and demonstrated safety issues related to the use of estriol.

4. Details on the scientific and medical research supporting the FDA's decision to ban estriol.

5. A listing of the studies reviewed by the FDA regarding the safety and effectiveness of estriol.

The letter was dated April 15, 2008, and a reply was requested within two weeks.

We still do not have any of the information requested from the FDA.

Also, we still do not have:

*The notice of the open hearing that is required for the FDA when decisions of this magnitude are made.

*The minutes of the meeting in which the decision was supposedly made.

*A list of individuals present at the meeting.

*What business was conducted at the meeting.

After all is said and done, someone (or some individuals) at the FDA should be held totally accountable and even lose their job if this is discovered to be an unfounded decision. If any fraud or criminal wrongdoing is involved (possibly with collusion with the pharmaceutical industry), the FDA individuals need to be prosecuted as allowed by law. At the minimum, a Congressional investigation should be initiated.

Sound extreme? I don't think so. Look at the millions of women's lives that are being adversely affected by this; look at all the "wasted time" involving physicians, pharmacists, and patients in responding to this. Look at all the apprehension and anxiety caused by this decision. No, it's not extreme�it just points out what can happen when a government agency goes awry and presumably makes decisions for the wrong reasons. Obviously, if there is documentation of safety issues and documentation of harm, then all the above is retracted and an apology is offered. If not, then an investigation needs to be made into the operations of the department of the FDA that was involved in this decision.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Question: I know that the responsible pharmacist must have a training program available; what does this mean?

Answer: Standard operating procedures covering the training of every individual involved with compounding sterile preparations must be available and followed. Training programs can be a combination of on-site, audio-video, classroom instruction, and other methods approved by the responsible pharmacist. Participation by each individual must be documented and maintained. This is in addition to the media-fill testing, glove finger-tip testing, etc.

Heparin Price Doubles
Major dialysis centers say the price of heparin has doubled since mid-April because of global recalls and tight supplies since the discovery of contaminated raw product from China. APP Pharmaceuticals is the sole supplier in the U.S. for therapeutic heparin for surgeries and dialysis after Baxter International recalled its China-sourced product.
ASHP Daily Briefing, May 9, 2008

In a related story, China's State Food and Drug Administration accused Baxter International of failing to provide all of the data and samples requested during an inspection of its heparin plant in New Jersey. Baxter says it has been and will continue to cooperate in the investigation. Editors Note: Not only do the drug companies have to deal with the U.S. FDA, they also have to deal with the individual countries' drug regulatory agencies. It appears that the heparin issue is becoming more problematic each week.
http://www.ft.com/cms/s/0/3587b9b0-1ba7-11dd-9e58-0000779fd2ac.html

Tilade Discontinued
King Pharmaceuticals has announced that they will no longer manufacture Nedocromil Sodium Inhalation Aerosol (Tilade) partly because they cannot identify "a qualified manufacturer for a chlorofluorocarbon propellant inhaler."
AHSP NewsLink, May 6, 2008

"King Pharma Profit Falls as Altace Sales Dive"
So reads the headlines. The article goes on to state that they posted a 24% drop in first-quarter profit; their profit fell to $87.6 million for the first quarter!
http://pharmalive.com/news/index.cfm?articleID=538432&categoryid=9&newsletter=1

New Wholesaler?
Wal-Mart is expanding its low-priced drug program and will offer certain 90-day generic prescriptions for $10 and sell more than 1,000 OTC medications for $4 or less. Editors Note: Maybe independent pharmacies should purchase their pharmaceuticals from Wal-Mart?
Pharmacists e-view, May 5, 2008

The following statement was in last week's newsletter:
"The Government Accountability Office said this week that it would cost the FDA about $70 million a year to keep tabs on overseas drug manufacturers."

Well, this week, FDA's Woodcock backed away from comments that appeared to agree that the FDA needed an additional $225 million to beef up foreign inspections. Editors Note: In just a few days, the cost went from $70 to $225!!!! Someone needs to realize they are working with "real dollars" from "us"! As mentioned last week, it is the taxpayers that are subsidizing the drug companies "savings" when they outsource overseas. It's time to bring drug manufacturing back into the U.S., even if it requires changing some laws. http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1774744&contentType=sentryarticle&channelID=33

In a related story, the FDA announced last week it will recruit more than 1,300 biologists, chemists, pharmacologists, and other personnel by October to expand its product-approval and safety operations. http://www.signonsandiego.com/news/health/20080430-0827-fda-.html

The FTC is trying to block "reverse payments" in the drug industry? Reverse payments is a practice where the major pharmaceutical companies pay generic drug companies to delay launching their products. The major company can pay several million to the generic company (clear profit) if they agree to delay placing their product on the market. Meanwhile, the major company continues to bring in many more millions from the sales of the product.
http://www.iht.com/articles/2008/05/07/business/pharma.php

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Charging Electronics
Periodically, allow battery-powered electronic devices to totally discharge, followed by recharging. This will generally make the batteries last longer.