Saturday, March 19, 2011

new statement from KV Pharmaceuticals

Well, guys, maybe everyone's complaints and concerns are actually being heard. KV released a new statement today regarding the price of Makena. For those of you contributing to the noise, keep it up!!

*Edited to add:

Has anyone seen/heard that compounding pharmacies can still make an FDA approved drug if it is deemed appropriate by the medical provider? Wonder if there is any truth to the claim. Sorry some of the references are taken out of context, didn't want to copy/paste the entire article, which is posted here.

The compounding pharmacies for now are striking a defiant pose. On March 14, the International Academy of Compounding Pharmacists issued a statement to patients and providers saying that, although many pharmacies had received a warning letter dated Feb. 17 from Ther-Rx that they could no longer compound an FDA-approved medication to which Ther-Rx had exclusive marketing rights, "In our estimation, the letter is nothing more than a ‘scare tactic.’ ... Pharmacists can legally compound FDA approved products when a prescriber determines that the compounded preparation is more clinically appropriate for an individual patient."

David G. Miller, R.Ph., the group’s chief executive, said in an e-mail that the answer to the question of whether 17P can legally be compounded, in light of an FDA-approved product with market exclusivity, was "clear and simple."

"If a prescriber determines that a compounded preparation of a medication is in the best clinical interest of his or her patient and discusses the available options with a pharmacist, there are no statutory or regulatory prohibitions on that professional decision," Mr. Miller said.

One criticism raised by Mr. Miller and others was that Makena had received FDA approval in part as a way to offer 17P with guaranteed consistency across the market. However, Ther-Rx’s parent company, KV Pharmaceutical Company, has recently faced legal trouble over active-ingredient inconsistencies and false labeling of its FDA-approved products.

Just last week, KV Pharmaceutical Company’s former chief executive pleaded guilty to breaching federal food and drug statutes by selling oversized morphine tablets.

Dr. Harman said he had no relevant financial disclosures.


mm said...

Haven't been able to get response to KV on the timing of the meetings. We need to keep the pressure on including driving to make sure the meetings occur. Hopefully KV is serious but it's possible that they are posturing hoping to break the momentum of the growing outrage

Candice said...

I'm really hoping that isn't the case. It seems as though they'd be really stupid to put that out there and not follow through, especially given the response thus far. But then again I would have said they'd be really stupid to try to pass along a 100x price increase, too. Hopefully they are genuine, as it would honestly be in their best interest in my opinion. They could have increased the price by a reasonable amount, still made a huge profit and no one would have said a word. So much greed!

Cyndi Hendrickson said...

I found your blog again! All I had to do was look at my newsfeed! Hahahaha! I'm glad you're still updating on this. I've been catching tidbits here and there - mainly by reading the blogs. This is unbelievable. I'm so disappointed in MOD's association to this. But I was really happy to read today about the compounding pharmacies and their "defiant pose." Good for them! Perhaps all of this virtual outrage is being noticed!