Move over KV Pharmaceuticals, you are not alone! Readers will recall that KV got itself in hot water with Congress, thrid-party payers, physician's groups, patients advocates, various foundations and the Mormon Tabernacle Choir and the Baja Marimba Band when it introduced an FDA approved version of progesterone, called Makena, for the treatment of some high-risk pregnancies.
The problem was that it raised the price of the newly "approved drug" from about $20 to $1500 per dose. The sound that arose from critics was liken to an orchestra of scorched cats. KV had to quickly back off on price but not before losing the support of long-time sponsor The March of Dimes and having the FDA refuse to enforce an prohibitions on use of "non-approved" versions of the drug made in hospital formularies.
Now, URL Pharma and Avanir Pharmaceuticals may be moving into the same dangerous territory. URL Pharma has introduced its version of the old drug, colchicine, under the brand name Colcrys for the treatment of gout. In doing so, it raise dthe price from pennies per dose to about $5. Maybe that doesn't seem quite as egregious as the KV case due to lower nominal amounts but it still drew Congress' attention. Sen. Kohl and Sen. Waxman have written a letter to URL's CEO to 'splain himself on pricing. Uh-oh, this was the similar move KV experienced before all hell broke loose. URL has vigorously defended its pricing as competitive with other gout medications.
Similarly, Avanir markets a drug called Nuedexia, a combination of the legacy drugs quinidine and dextromethorphane, for the treatment of a rare condition called pseudobulbar affect (involuntary emotional outbursts). It pricing raised the ante from about $20 for the old drugs to about $600 for the new. Again, their CEO recieved his Congressional letter in the mail asking about the pricing rationale for the product.
Clearly, all three of these companies took drugs they did not invent (or in some cases even manufacture), but added quality controls and clinical trials to the process to enhance the safety profile. The question is -- what is legit in terms of the mark up for these quality enhancements to compensate them for their investment? Clearly they should be able to earn that back, but not by exhorbitant pricing - particularly given the drugs in question had decades of use prior to their "improvement" by FDA licensing. A balance needs to be struck between profit motive and patient gouging. It looks like companies and Congress will need to zero in on where that balance lies.
Posted by Bruce Lehr May 26th 2011.