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March 25, 2011 Volume 8, Issue 12
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IACP Annual Meeting and Compounders on Capitol Hill - June 11-14, 2011

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Loyd V. Allen, Jr., Ph.d., R.Ph  Letter from the Editor
Loyd V. Allen, Jr., Ph.D., R.Ph.


Editorial: Insurance Plans Support Hydroxyprogesterone Caproate Compounding

A letter has been sent from the President and CEO of America's Health Insurance Plans to FDA Commissioner Margaret Hamburg. The letter questions the actions of the Agency and KV Pharmaceuticals in granting exclusivity under orphan drug status and the extraordinary price increase for the drug.

The letter states that "Specialty pharmacies have, for many years, been custom-compounding the 17P treatments, but we have received reports that these compounding pharmacies have been told by the manufacturer that they no longer can supply these drugs without being subject to FDA penalties".

The letter further states "For more than five years, 17P was provided as the "standard of care" via these specialty pharmacies with no apparent reports of safety or quality concerns with this compounding. Limiting access to an affordable therapeutic option will negatively impact many women who need this drug, especially the underinsured and Medicaid populations, while increasing premiums for others".

Finally, the letter urges the FDA to provide clear guidance so that patients and physicians continue to have the option to access the compounded hydroxyprogesterone caproate through compounding pharmacies. This will keep the drug widely available and affordable for patients and families for whom it offers great hope.

See the accompanying news releases about Makena below. It is now actually encouraging that insurance companies seem to see one of the values of compounding in meeting their patients needs in an affordable and effective way.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

 
Other News

KV and Makena Under Fire
US Sen. Amy Klobuchar is calling for an investigation into the price gouging and potentially anti-competitive behavior of KV Pharmaceutical. Both Sens. Klobuchar and Sherrod Brown have sent a letter to the Federal Trade Commission Chairman Jon Leibowitz urging the agency to launch a probe into Makena, stating that the drug has been safely administered at a cost of between $10 and $20 per injection, but since KV was granted orphan status for its version of the drug, the cost rose to $1,500 per injection.

"This is a proven and affordable drug that has been around for over 50 years. It's critical that we make sure this company isn't taking advantage of its orphan-drug determination to monopolize the market and engage in price gouging at the expense of pregnant women," Klobuchar said. Brown said. "Last week, I called on KV Pharmaceutical to immediately reconsider their decision, but to this date the company continues to defend this astronomical price increase. Price-gouging is never acceptable, particularly not when it undermines public health and fleeces taxpayers. Families deserve an investigation."
http://assets.bizjournals.com/twincities/news/2011/03/18/klobuchar-wants-kv-drug-investigation.html

KV Pharmaceuticals' March 7 price increase is "unconscionable," Sen. Brown wrote in a USA Today op-ed. They did not invent the drug progesterone, but bought exclusive rights to it and named it Makena. When it received approval from the FDA recently, KV decided to increase the price with the justification that their research found the cost of the drug is still less than that of having a premature baby, Sen. Brown wrote in the op-ed.

Days after the drug company's announcement, Brown sent a letter to KV Pharmaceutical CEO Greg Divis requesting the company reconsider the price hike that could cost $30,000 per pregnancy, but has not received a response.
http://www.nationaljournal.com/healthcare/sen-brown-drug-price-increase-from-10-to-1-500-is-unconscionable--20110321?mrefid=site_search

Thyroid Drug Shortage Looms Ahead
A soon to be experienced shortage of Thyrogen has been announced by Genzyme Corporation because of a manufacturing issue. The Cambridge-based company announced that it is warning doctors to prepare for a shortage from mid-April to Mid-June. Thyrogen is used in the treatment of thyroid cancer.
http://www.boston.com/business/healthcare/articles/2011/03/19/genzyme_warns_of_thyroid
_drug_shortage/

Medco Paid Millions to the California Public Employees' Retirement System (Calpers) Bribery Suspect
Medco Health Solutions acknowledged that it paid Alfred Villalobos, the man in the middle of the CalPERS bribery scandal, more than $4 million to work on issues relating to the pension fund. CalPERS has dumped Medco as administrator of a drug-benefit contract after the release of a report saying the New Jersey company hired Villalobos to help win the contract back in 2004. The day Medco was awarded the contract, the company gave Villalobos a $1 million check, the last installment on the $4 million agreement.

Medco said it hired Villalobos "primarily" for his advice with a major audit by CalPERS in connection with previous work Medco had done for CalPERS. The audit was "lengthy, contentious and highly detailed," the company said in its filing. "The audit was successfully concluded and the outstanding issues were resolved."

Villalobos was sued by state officials last year; he was accused of bribing former CalPERS Chief Executive Fred Buenrostro and others to win business for his investment clients.

In the SEC filing, Medco doesn't go into detail about the audit but in 2002, the company paid $42 million to settle class action claims that the company had pocketed huge rebates from drug makers; rebates that should have gone to employees of the health plans that hired the company. At the time, the company was called Merck-Medco and was a subsidiary of drug maker Merck & Co.
http://pharmalive.com/news/index.cfm?articleID=769061&categoryid=9&newsletter=1

FDA: Over-the-Counter Asthma Inhaler Will Not Be Sold After Dec. 31
The FDA has announced that the only over-the-counter asthma inhaler sold in the US will no longer be available after December 31, 2011. Primatene Mist uses chlorofluorocarbons (CFCs) as the propellant in the medication and the U.S. signed an international agreement to phase out their use. The FDA emphasized that safe and effective alternatives for treating asthma symptoms are available.
http://www.foxnews.com/health/2011/03/17/fda-counter-asthma-inhaler-sold-dec-31/

 
Book Review

The APhA Complete Review for Pharmacy, 8th Edition
January 2011. 928 pages, Paperback. $64.95

The APhA Complete Review for the FPGEE (Foreign Pharmacy Graduate Equivalency Examination)
August 2010. 604 pages, Paperback. $150.00

Both books are published by the American Pharmacists Association, edited by Dick Gourley and written by current or former members of the faculty of the University of Tennessee. They are very well-organized and presented in an easy-to-study fashion. The content is nicely summarized so a lot of material can be covered efficiently in a short amount of time. Both books can serve to assist candidates in preparing for the respective exams or as reviews for current practitioners.

 
Did You Know...

Makena is used as both a boy's name and a girl's name. It is of Hawaiian origin, and the meaning of Makena is "abundance" and "happy one". I guess that's how KV's new baby is projected!

 
Compounding Tip of the Week

Tax Time
Tax time is almost here. Refunds from e-filed returns are supposed to be deposited in about two weeks; refunds from mailed returns still take about 6 weeks.

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