In March of this year the FDA took the unusual step of allowing an “unapproved” compounded drug to remain on the market to explicitly make sure Americans could afford that product. That drug is hydroxyprogesterone caproate, branded by K-V Pharmaceuticals as Makena, the first FDA-approved drug to prevent the risk of preterm birth in certain women. Will more such government interventions continue in support of drug affordability?
According to the Wall Street Journal Blog,“Typically, whenever a drug is approved, pharmacy compounding isn’t allowed and the FDA acts to remove any unapproved drugs that might on be the U.S. market.” However, the FDA is allowing the compound to remain solely because of the outrageous cost for the brand-name product; Makena is priced at $1,500 per dose! Before Makena was approved, the same drug without the K-V branding and FDA stamp of approval cost between $10 – 20 per dose.
To the best of our knowledge, the FDA’s role does not include controlling prices to help Americans have access to the medication they need. However, that is precisely what the FDA did in the case of Makena. In our opinion, that’s also what the FDA does by not enforcing certain personal drug importation laws that, if enforced, would prevent Americans from affording needed medication. Currently, under its personal drug importation policy, the FDA has stated it does not take enforcement action against individuals who import non-controlled medicines, which are generally (and ironically) viewed as not FDA-approved even if they’re the exact same drug sold here, often due to labelling or pill color and shape differences between otherwise identical products.
Recently, some lawmakers are up in arms about the costs of Colcrys (a gout drug by URL Pharma), and Nuedexta (Avanair Pharmaceuticals’ pseudobulbar affect drug) –both about $5 per pill. Like with Makena, the compounded versions of these products cost much less, only a few cents per pill. It will be interesting to see if the FDA also allows unbranded compounds for Colcrys and Nuedexta to hit the market, even though they are not “FDA-approved”. Such actions, which make needed medication affordable, make it easy to applaud the FDA.
