Thursday, May 5, 2011

Soapbox Again

Finally got some replies from Congressman and Senator on KV Pharmaceuticals/Makena.  (Unaware?  Read Here and Here).  I was very disappointed.  I knew I'd get nothing more than a form letter, but I guess I at least expected a well put together form letter.  Here is the first from my Congressman Womack...well I guess he wont be mine for much longer since we got a lovely redistricting...solves the problem of not voting for him huh?

It said......

Dear Erin,
Thank you for contacting me regarding the pharmaceutical Makena.  It is good to hear from you.
On February 4, 2011, the United States Food and Drug Administration (FDA) approved the KV Pharmaceutical drug, Makena, to help prevent premature birth in women who have previously had a preterm delivery.  This is the first such drug approved by the FDA. Makena was approved under FDA's accelerated approval process, which allows promising drugs to be approved for use based on the ability to show a benefit on a 'surrogate endpoint' that is likely to predict an actual clinical benefit 
According to the March of Dimes, one in every eight babies born in the United States does not complete gestation.  Babies born prematurely tend to have greater complications and higher health costs over the span of their lives. Makena could save lives and help to produce healthier babies that become healthier adults. 
Prior to its FDA approval, 17-Hydroxyprogesterone, the chemical name for Makena, was combined by a compounding pharmacist and provided to patients for around $10 per treatment. I do not believe the government should be fixing prices for products sold by private industry.  I am encouraged by KV Pharmaceutical's recent announcement lowering the price from $1,500 to $690 per injection and the assistance they plan to provide to certain patient groups.   I am hopeful KV Pharmaceuticals will continue to reevaluate the pricing to ensure this lifesaving product is accessible for all mothers. 
Thank you again for contacting me regarding your concerns with drug pricing.  Please continue to keep me informed of the issues that are important to you and be sure to visit my website,, for more information and to sign up for my newsletter.

                                                                       Congressman Signature
                                                                       Congressman Steve Womack
                                                                       Member of Congress

1) Oh my goodness...I had no idea what Makena was, thats why I wrote you!
2) Really...I had no idea (being a mom of a child born at 28 weeks)what a preemie was and what that meant!
3) Your stats are wrong...1 in 8 babies are born prior to 37 weeks..."complete gestation" is 40 weeks..or 42...due dates are just estimations. 
4)So glad for the cost decrease...I mean $690/per week for like 19 weeks (what I will be doing) is SO doable.
5) Love how it was signed "Congressman Signature"  Awesome...
6) No...I'd rather NO get your BS newsletter. 

Second letter.  I've always likes John Boozman.  He seemed like a good guy.  But unfortunately I think his current office has gone to his head.  Now, his letter wasnt as bad.  But still not quiet what I expected and its making me seriously rethink my vote...

It said...
Dear Mrs. Rxxxxx,
Thank you for contacting me to express your concerns regarding the recent pricing change for the drug 17-hydroprogesterone caproate. It is good to hear from you.
As you may know, 17-hydroprogesterone caproate has been sold as a compound put together by pharmacists under the name "17P." KV Pharmaceuticals recently submitted information to the U.S. Food and Drug Administration (FDA) requesting approval for the sale of 17P under the brand name "Makena." After receiving approval, KV Pharmaceuticals sent cease-and-desist letters to pharmacists to stop compounding 17P. Finally, on March 7, 2011, KV Pharmaceuticals announced that Makena would be sold at $1,500 per dose, much higher than the $10 or $15 per dose pharmacists charged for 17P.
I understand your concerns and your desire to see the FDA uphold compounding pharmacists' rights to continue compounding 17P. However, you should know that the FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of drugs. The agency can neither regulate drug prices nor enforce a business's rights to continue producing or selling a product.
That being said, Senator Sherrod Brown (D-OH) and Senator Amy Klobuchar (D-MN) did sent a letter to the Federal Trade Commission (FTC) calling for an investigation into KV Pharmaceutical's actions. Senator Brown also sent a letter directly to KV Pharmaceuticals asking them to reconsider the pricing for Makena. Please be assured, I share your concerns regarding KV Pharmaceutical's activities and I will monitor the FTC's investigation into the matter. 
Again, thank you for contacting me on this very important issue. Please be sure to visit our website at www.boozman.senate.govI look forward to your continued correspondence.

John Boozman
U.S. Senator

1) Yes I KNOW that 17P had been available for less through compounding pharmacies...what is with telling me everything I just told you?  Do you find your constituents THAT stupid?
2)Protecting me?  From what?  Compounding pharmacies have been putting this drug together for years, I think like 50 years, there have been NO quality issues.  These are NOT back alley crap holes, they are licensed pharmacies and pharmacists.  The new Makena has perservatives...has that been tested?  Is that safe? 
3) How does making a neccessary drug unattainable for those who need it, risking lives and health of babies help or "protect" us?
4) I dont like the idea that the govts job is to "protect us".  Protect us?  Or yank freedoms?
5) I know that the FDA doesn't influence pricing but my concern is (if you read the email I sent)  is that the FDA took this drug, handed it over to KV Pharma, a bankrupt unethical company.  Good move.

Also love how all these responses came in AFTER the price had been dropped.  AFTER the society of OB/GYNS boycotted KV Pharma.  AFTER the March of Dimes pulled their partnership.  AFTER the FDA issued a statement that compounding pharmacies can continue to make the drug.  Pretty much after the publicity died down, and after there was a resolution (for the most part) THEN and ONLY then do they reply telling me how they care, and are helping, yada yada yada BS BS BS.