Happy July! I hope you are enjoying a happy and safe summer so far! I want to share with you a recent adventure Jeff and I had! We traveled to Washington, DC for the annual IACP (International Academy of Compounding Pharmacists) COMPOUNDERS ON CAPITOL HILL event. IACP is the political group we have in Washington to keep their finger on the pulse of legislation and work to protect the rights of compounders (and thus YOU and your access to compounded medications!) in our country. We were very excited to meet our U.S. Senator from Ohio, Sherrod Brown along with representatives from Speaker of the House John Boehner's office, U.S. Senator Rob Portman, Representative Mike Turner and Representative Jim Johnson. We spoke with them about 4-5 legislative concerns we have that could potentially compromise the rights of compounding pharmacies. Our goal was to bring awareness and education to these issues in hopes of gathering support to continue to protect our rights. The response was very favorable. In fact, I must tell you that our senator Sherrod Brown is most interested in continuing his support FOR compounding pharmacies. The reason is an interesting one and one you may have heard about. It is the story of the KV Pharmaceutical Company and the development of the drug "Makena" versus what we make in our compounding pharmacy (Piqua Medicine Shoppe and Compounding Pharmacy) and other compounding pharmacies make across the country, called "17 hydroxyprogesterone" injectable. This injectable drug is given weekly during pregnancy to keep pregnant women who are at high risk of premature delivery from going into premature labor. Our charge for this compound (17 hydroxyprogesterone injectable) is between $10-$20 per injection. This adds up to between $300-600 total to keep the baby from delivering early. KV Pharmaceuticals-using the "orphan drug law" provision got FDA approval
|
Jeff Hogrefe and Senator Sherrod Brown on the left |
to manufacture "17 hydroxyprogesterone injection." As it became commercially available, KV Pharmaceuticals got exclusive "rights" to this product, and sent warning letters to Compounding Pharmacies threatening legal action by the FDA if we continued to compound this drug for our high-risk pregnant women. The March of Dimes and National OB/GYN Groups initially supported KV Pharmaceuticals UNTIL they announced the price of their brand name drug "Makena" which contained the same medication as our 17 hydroxyprogesterone injectable) would be $1500 per injection! (Yes, you read that right! We have made this drug for years and charged $10-$20 per injection. KV is charging $1500 per injection!) THEN THE OUTROAR ENSUED! Let's see.....$10 vs $1500......Medicaid programs, private insurance and even self-pay women...instead of paying $300-600 for 20 injections to keep their pregnancy intact would now have to pay $30,000! So what happened?
� Congress got involved in an investigation. Senator Sherrod Brown, for one, read us letters HE had received from high-risk pregnant women who were forced to come up with $30,000 (!) to save their unborn child....when they could have spent just $300-600 for this same injectable from their neighborhood compounding pharmacy
� The FDA, for the FIRST TIME EVER, initiated a letter that stated they are going to support and allow compounding pharmacies to compound this product by NOT ENFORCING their own regulations!
I must tell you that THIS action by the FDA was history in the making. Never before in our history has the FDA ever (ever!) NOT enforced their own regulations! This uproar and the subsequent congressional investigation and actions by the FDA resulted in KV Pharmaceuticals lowering the cost of their drug, "Makena," to $700 per injection.
|
Ohio Pharmacists, including Jeff and Lyn Hogrefe front left; Senator Sherrod Brown far right |
So, there you have it! The story of David (us) vs Goliath (KV Pharmaceuticals). Senator Sherrod Brown called us the "good guys" (the guys in the white hats!) who really ARE ALL ABOUT HELPING THE PEOPLE IN OUR COMMUNITY and NOT motivated solely by making money. It felt really good to come away from Capitol Hill with our heads held high, knowing that what we do and the difference we make EVERY day is motivated by integrity and passion for our customers. We will continue to carry on and to fight for our rights AND YOURS by continuing to support IACP, our political group, so we can continue to monitor legislation to protect our rights as compounders.
I hope your awareness of compounding pharmacies and what we do is heightened by what you have just read. It's always good to take a step back and examine our beliefs when we hear and read of stories like this. It makes ME feel good to know there are people in Congress who will fight for us and support us when we need it most.
If YOU would like to be a part of the grassroots movement to protect the rights of compounding pharmacies, and thus the rights for US to continue to make YOUR customized hormone therapy, you can go to iacprx.org and go to P2C2 to register. This will enable you to get updates on compounding issues that are going through legislation. You will also be given information on how to email your congressman so that YOUR voice will be heard. Together we CAN!
Warmly,
Lyn