This time, the FDA rejected a petition KV had filed in hopes of preventing agency approval of a generic version of Delalutin, an older version of Makena, or hydroxyprogesterone caproate. KV argued that the FDA should not approve a generic because this would violate its exclusive marketing rights for Makena under the Orphan Drug Act (here is the petition).
How so? KV maintained that an approved generic could, theoretically, be marketed on an off-label basis for preventing premature births, even though the original approval given Delalutin was for treating adenocarcinoma of the uterine and abnormal uterine bleeding to hormone imbalances in women who are not pregnant.
For the record, Delalutin had once been sold by Bristol-Myers Squibb, but the drugmaker requested its marketing application be withdrawn in 1999 because the treatment had not been marketed for several years. The FDA complied the following year, noting the withdrawal was not due to safety or efficacy reasons. McGuff Pharmaceuticals wants to sell a generic version of Delalutin.
In explaining its decision, the FDA maintained that approving a generic would not violate orphan drug exclusivity because the approved indication would differ from what was granted for Makena. And the hypothetical argument made by KV was shot down because approval would conform with the law and potential off-label marketing is not a factor in such decisions.
The FDA cited a previous court decision where another drugmaker unsuccessfully attempted to make the same argument. In that case, the FDA wrote, a court concluded that the law permits a generic applicant to "carve out a protected indication even when it is likely that the generic drug, once approved, will be used off-label" for another indication (here is the FDA letter to KV, an earlier letter from McGuff).
In short, this conjures up the old cliche 'nice try, but no cigar.' This is a refrain that KV has heard before when tussling with the FDA. Last fall, a federal judge tossed a lawsuit in which KV claimed the FDA abdicated its responsibility to prevent some compounding pharmacies from offering lower-cost versions of Makena.
That decision came just weeks after KV filed bankruptcy and blamed FDA inaction against compounders for its financial woes. The drugmaker had also filed lawsuits against several states over the refusal of their state Medicaid programs to cover Makena, although at least one settlement was later reached.
For those who may not recall, the FDA two years ago approved Makena under the Orphan Drug Act, but shortly afterwards, both the drugmaker and the FDA came under fire after KV set the price at $1,500, compared with $10 to $20 a week for compounded versions of a med that has been used for decades.
In response, the FDA took the unusual step of deciding not to prevent compounders from compounding, and in doing so, inserted itself into an especially heated controversy. As we noted then, the FDA would normally have banned the sale of older, unapproved drugs, and KV, in fact, had already sent letters to compounders threatening legal action.
But the Obama adminstration was concerned about harsh publicity over Makena pricing since a federal agency had allowed a monopoly to develop (read this, this and this). The FDA decision not to pursue enforcement actions against compounders, unless there was a safety issue, was significant because the agency was dragged into a debate over cost.
As a footnote, though, to this debate, KV did have a 'we told you so' moment recently when the New England Compounding Center recalled numerous products - including a compounded version of Makena - due to the fungal meningitis outbreak that has claimed 39 lives (see this). KV had tried to convince the FDA that some compounded versions were unsafe, although the samples reviewed by the agency did not indicate any safety problems (read here).
thumbs down pic thx to italianvoice on flickr