Editorial: No recourse for patients and consumers!

Since I received very little feedback from the newsletter last week, I thought I might update it and repeat it this week, as it has MAJOR IMPLICATIONS for all of us!

Federal Agencies say their rules pre-empt injury suits! [PharmaLive.com Monday, March 31, 2008]

If a prescription drug causes injury, the FDA now says you can't sue the maker for injury if it met the agency standards! Not only is the FDA saying this but also the Consumer Product Safety Commission, National Highway Traffic Safety Administration, etc. We already know the standards developed by different agencies of the government are not perfect, but this is a big blow to consumers; especially those that receive prescription drugs that have little choice in their selection. Consequently, these adverse events, including death, are going to occur and now the consumer has no recourse. Think about this as you read the following headlines from this week and refer back to the newsletter of two weeks ago to the list of top 10 drugs causing deaths in recent years. It seems our agencies are not protecting consumers�they are prohibiting them from seeking damages in the event a flawed product is approved by "them" and causes harm! (Editors Note: This doesn't seem right. Think about this as you read the following, which came out this week.)

*J&J claims pre-emption defense in Ortho Evra cases: J&J attorneys are arguing that THE COMPANY CANNOT BE SUED by the over 3,000 patients and their families who claimed the drug caused heart attacks, strokes, and 40 deaths, BECAUSE THE FDA CLEARED THE PRODUCT! http://www.nytimes.com/2008/04/06/washington/06patch.html?_r=2&ref=health&oref=slogin

*Pfizer's Exubera may increase the risk of developing lung cancer with 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients. Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and Dear Patient Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera.

*FDA cites 62 reports of possible heparin deaths.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1762537&contentType=sentryarticle&channelID=33

FDA, CMA, AND RMPC
In March 2007, CMS Contractors issued a Local Coverage Determination (LCD) advising that claims submitted for all compounded inhalation solutions would be denied as "not medically necessary" effective July 1, 2007. This reversed a twenty-year-old policy of reimbursing compounded drugs under the same pricing rules. The new policy discriminates against compounding and is without medical rationale or scientific support according to Respiratory Medication Providers Coalition (RMPC) leadership that has rallied congressional support for compounding in Washington. It is also without any legal rationale based on an August 2006 federal court case ruling, Medical Center Pharmacy et. al. v. Gonzales, that ruled against the FDA's authority regarding compounding.

The FDA encouraged CMS to put up barriers to billing legally prepared compounded inhalation drugs, and CMS complied by issuing this new policy. RMPC has been successful in introducing legislation to reverse CMS's discriminatory policy against compounded medicines. To contact your local Congressperson and Senator for their support, please email your name and address to the following email link savecompounding@qx.net. RMPC will then provide you with a customized letter for your signature to send to your local Members of Congress.

PHARMACEUTICAL COMPANIES BILLING THE GOVERNMENT FOR HUNDREDS OF MILLIONS OF DOLLARS FOR DRUGS THAT DON'T WORK!
Senator Chuck Grassley was made aware of a 3.5 million dollar plan designed by drug companies to get doctors to switch patients to Vytorin from cheaper statins. He also learned that the principal research of the ENHANCE trial indicated the companies (Merck and Schering Plough) may have delayed publication of the trial results (presented in last week's newsletter) for marketing purposes. Senator Grassley commented:

"When a company bills the federal government hundreds of millions of dollars for a single drug, then it's important for the government to know how the drug works and that the therapy is cost-effective. At this time, experts are calling upon physicians to return to cheaper statins and await the finding of future studies."

IJPC supplies this list of providers of USP Chapter <797> products as a service to our readers. We strongly urge you to support the current advertisers and supporters (listed in bold) of IJPC. In next week's newsletter, the resource directory will feature Air Sampling Devices.

IJPC's May/June 2008 issue included part 1 of an article on microbial air sampling equipment as it relates to USP Chapter <797> standards. Our July/August 2008 issue includes part 2 of this informative article, which features testimonials from compounding pharmacists about the models of air samplers used in their pharmacy.

Don't miss this valuable information! Subscribe today online at www.IJPC.com/Subscriptions or call 800-757-4572.

Geocillin (carbenicillin indanyl sodium) tablets have been discontinued by Pfizer. Currently, there are no other FDA-approved manufacturers for carbenicillin tablets.

A Turning Point for Pharmacy?
Get involved! If you don't, you may not have much of a future left. With decreasing reimbursements, FDA intrusion into pharmacy practice, drug companies' monopolies and political influence, and dangerous drugs being approved, pharmacists are fighting back. A post on the CNL this week described the 80/20 rule; 20% of the pharmacists are fighting for the profession while the other 80% sit back and accrue the benefits of their hard-fought labors. Enough is enough! If you want to continue to practice pharmacy, you have to get involved. Too many changes are in the works to drastically change the profession. SOME PHARMACISTS MAKE THINGS HAPPEN, SOME PHARMACISTS WATCH THINGS HAPPEN, AND OTHER PHARMACISTS WONDER WHAT HAPPENED!